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Boston Area Chapter Current Year Events List

Event
ISPE Student Development Committee Meeting
Date: 3 January 2017

This is a regular meeting for the Student Development Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 4 January 2017

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 9 January 2017

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 10 January 2017

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Design Review and Optimization of SIP and CIP Processes
Date: 19 January 2017

PRESENTATIONS
John Hyde: http://www.ispeboston.org/files/cip_optimization_-_hyde.pdf

Joe Povenski: http://www.ispeboston.org/files/evaluating_sip_and_sterilization_methods_-_povenski.pdf


Framingham State University

D. Justin McCarthy Campus Center - Forum Auditorium
100 State Street
Framingham, MA 01701

EVENT INFORMATION: 
You are invited to attend a live program on optimized process systems design strategies and microbial preventative measures.  The program will be held at Framingham State University’s D. Justin McCarthy Campus Center – Forum Auditorium in Framingham, MA (venue kindly provided by the Framingham State University, Biotechnology Program).  The event will feature a networking reception with appetizers and refreshments, and a live Q&A session after the presentation. Register now for this great program!

Current Best Practices for Biopharma Process Systems Design Strategies for Optimized CIP Performance (John Hyde). John will present a number of recent design reviews providing case studies to illustrate the concepts.

Prevention of microbial ingress within biologics process (Joe Povenski). Prevention of microbial ingress within any biologics process offers numerous challenges.  If any measure or control is ignored or discounted, the frequency of a contamination event can increase exponentially. Any risk to the process should be acknowledged and remediated when possible, even when considered quantitatively low. Evaluating sterilization methods in response to such an event is critical and a key to the overall success of the investigation. The goal of the presentation is to review sterilization principles and how to identify sterilization deficiencies within the overall investigation roadmap. 

WHO SHOULD ATTEND: 
Validation and Facility Engineers, Quality Assurance Professionals, QC Microbiology and Contamination Control Professionals, Capital Projects Managers, Manufacturing Science and Technology Engineers.

SPEAKERS:
John Hyde, Chairman and Founder, Hyde Engineering + Consulting, Inc.
John Hyde founded Hyde Engineering + Consulting, Inc. in 1993 and specializing in process engineering, process and equipment validation, and compliance consulting for biopharmaceutical and pharmaceutical manufacturers. Hyde Engineering + Consulting, Inc. have operations in the United States, Europe, Singapore and India.

For nearly two years prior to the formation of Hyde Engineering + Consulting, Inc., John was Senior Project Engineer with Synergen, a biopharmaceutical research and manufacturing company located in Boulder, CO. His work at Synergen included design, start-up and validation of key process systems and the overall responsibility for the cleaning validation programs for the firm's large scale and clinical manufacturing facilities.  From 1982 to 1992, John was Manager, Process Design with Seiberling Associates, Inc., an engineering firm specializing in the design and start-up of biopharmaceutical, food and beverage process systems and the application of CIP technology.

Joe Povenski, Process Specialist, CRB
With 18 years of experience from the owner’s side ranging from process development to licensed commercial manufacturing, Joe hopes to give an end user, customer focused perspective when response to a microbial contamination event is warranted.  Having facilitated several microbial ingress investigations in the past, those experiences have lead Joe to a comprehensive understanding of all aspects of critical process design and microbial preventative measures.  

MEETING MANAGERS:
Robert Lucas, CAI
Gennady Malin, Sanofi Genzyme
Rami Mitri, Spectra Automation Ltd.

REGISTRATION FEES:
Before 1/12/2017: 
Member $50.00  
Young Professional Members $20.00 
Non-Member $95.00**
ISPE Student Members: FREE

After 1/12/2017: 
Member: $60.00
Young Professional Members $30.00 
Non-Member: $115.00**
ISPE Student Members: FREE
**Non-members may only attend one program as a non-member**

Thank you to our Sponsor:  

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ISPE RE-SHOWING: Design Review and Optimization of SIP and CIP Processes
Date: 26 January 2017

Pre-Registration is now closed. Walk-ins will be accepted on-site.

RE-SHOWING OF 1/19/2017 PROGRAM AT


Redhook Ale Brewery - Alemaker's Hall
1 Redhook Way, Portsmouth, NH 03801

AND WPI Biomanufacturing Education and Training Center at Gateway Park
50 Prescott Street, Worcester, MA 01605

AND Providence Marriott Downtown
1 Orms Street, Providence, RI 02904

EVENT INFORMATION: 
Join us on January 26, 2017 at the Redhook Ale Brewery in Portsmouth, NH; the WPI BETC at Gateway Park in Worcester, MA; or the Providence Marriott Downtown Hotel for a re-showing of the program recorded at Framingham State University. A networking reception, including refreshments and appetizers, will be hosted before the presentation at each location.

PROGRAM SUMMARY: 
Current Best Practices for Biopharma Process Systems Design Strategies for Optimized CIP Performance (John Hyde). John will present a number of recent design reviews providing case studies to illustrate the concepts. 

Prevention of microbial ingress within biologics process (Joe Povenski). Prevention of microbial ingress within any biologics process offers numerous challenges.  If any measure or control is ignored or discounted, the frequency of a contamination event can increase exponentially. Any risk to the process should be acknowledged and remediated when possible, even when considered quantitatively low. Evaluating sterilization methods in response to such an event is critical and a key to the overall success of the investigation. The goal of the presentation is to review sterilization principles and how to identify sterilization deficiencies within the overall investigation roadmap. 

WHO SHOULD ATTEND: 
Validation and Facility Engineers, Quality Assurance Professionals, QC Microbiology and Contamination Control Professionals, Capital Projects Managers, Manufacturing Science and Technology Engineers.

SPEAKERS:
John Hyde, Chairman and Founder, Hyde Engineering + Consulting, Inc.
John Hyde founded Hyde Engineering + Consulting, Inc. in 1993 and specializing in process engineering, process and equipment validation, and compliance consulting for biopharmaceutical and pharmaceutical manufacturers. Hyde Engineering + Consulting, Inc. have operations in the United States, Europe, Singapore and India. For nearly two years prior to the formation of Hyde Engineering + Consulting, Inc., John was Senior Project Engineer with Synergen, a biopharmaceutical research and manufacturing company located in Boulder, CO.

His work at Synergen included design, start-up and validation of key process systems and the overall responsibility for the cleaning validation programs for the firm's large scale and clinical manufacturing facilities.  From 1982 to 1992, John was Manager, Process Design with Seiberling Associates, Inc., an engineering firm specializing in the design and start-up of biopharmaceutical, food and beverage process systems and the application of CIP technology.

Joe Povenski, Process Specialist, CRB
With 18 years of experience from the owner’s side ranging from process development to licensed commercial manufacturing, Joe hopes to give an end user, customer focused perspective when response to a microbial contamination event is warranted.  Having facilitated several microbial ingress investigations in the past, those experiences have lead Joe to a comprehensive understanding of all aspects of critical process design and microbial preventative measures.  

REGISTRATION FEES:
Member FREE
Young Professional Members FREE
Non-Member FREE
ISPE Student Members: FREE

MEETING MANAGERS:
Robert Lucas, CAI
Gennady Malin, Sanofi Genzyme
Rami Mitri, Spectra Automation Ltd.

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ISPE New Year's Social
Date: 26 January 2017

Pre-registration is now closed.
Walk-ins will be accepted onsite.
If you have any questions contact the office at 781-647-4773.

 

Thursday, January 26, 2017
6:00 – 9:00pm
Blazing Paddles at Game On
82 Lansdowne Street, Boston, MA 02215

Start the New Year off by joining the Boston Area Chapter of ISPE for a night of Ping Pong and Baseball!! There will be prizes awarded for the Ping Pong tournament (sign up early).  The batting cage at Fenway Park is available for all to take a few swings. Sign up now and show off your skills on the table and in the cage!

Light fare and cash bar will be provided.

Tournament Prizes and 50/50 Raffle to benefit ALS

Thank you to our Sponsors:


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ISPE Student Career Workshop
Date: 28 January 2017

Pre-Registration is now closed. Walk-ins will be accepted on-site.

If you will be graduating in 2017-2020, come to a workshop specifically designed to help you to hone your skills and improve your chances of getting that internship, co-op, or full time position in the Life Science Industry.

ISPE Boston has assembled a group of industry experts to help you:

Take Inventory of Yourself
Why you are unique

Get the Interview
Resume building
Effective cover letters

Get the Job
First Impressions
Interviewing Tips
What employers look for

Build Your Network
Why networks are important
Where do I begin?

Build Your Career Path
Short and long term planning

Learn from Industry Pros
Young Professionals
Seasoned Veterans
Entrepreneurs

COST/REGISTRATION

Free for ISPE Student Members. Including materials, lunch, and refreshments

Not an ISPE member? Join and attend.

Join ISPE here www.ispe.org/join-or-renew

WHEN

Saturday, January 28, 2017
10:00 AM – 5:00 PM
Doors open at 9:30AM

WHERE

Northeastern University
Egan Hall
Raytheon Amphitheater
End of Forsyth Street
Boston, MA 02120

Here is a map of Northeastern University

What to Bring

Your Questions!
Business Cards
Dress is Business Casual

Want more information? Contact us at office@ispeboston.org or call 781-647-4773

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ISPE Young Professionals Committee Meeting
Date: 31 January 2017

This is a regular meeting of the Young Professionals Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 1 February 2017

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 6 February 2017

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Student Development Committee Meeting
Date: 7 February 2017

This is a regular meeting for the Student Development Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 7 February 2017

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Young Professionals Bowling and Networking
Date: 8 February 2017

Pre-registration is closed. Walk-ins will be accepted onsite. If you have any questions contact the office at office@ISPEBoston.org or 781-647-4773.

Back by Popular Demand! Join the ISPE Boston Area Chapter Young Professionals at The Flatbread Company in Davis Square for an evening of pizza, beer, socializing, and candlepin bowling at the famous Sacco’s Bowl Haven! Enjoy a variety of wood-fired, clay oven flatbread pizzas (vegetarian options will be offered) and salad. Bowling shoes will be provided and a cash bar will be available.

Space is limited to 50 attendees, so please get your tickets before it’s too late!

Wednesday, February 8, 2017
7:00 PM - 9:00 PM

The Flatbread Company
45 Day Street, Somerville, MA 02144

Registration Fees:
Member: $20
Non-Member: $25
Student Member: FREE

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ISPE Shifting Paradigms in Pharmaceutical Water and Steam
Date: 16 February 2017

PRESENTATIONS
Afternoon Presentations:
Brian Hagopian:  http://www.ispeboston.org/files/ispe_feb_16%2C_2017_hagopian_afternoon_handouts.pdf
Joe Manfredi: http://www.ispeboston.org/files/ispe_feb_16%2C_2017_manfredi_afternoon_handouts.pdf

Evening Presentations: 
Brian Hagopian: http://www.ispeboston.org/files/ispe_feb_16%2C_2017_hagopian_evening_intro_handouts.pdf
Joe Manfredi: http://www.ispeboston.org/files/ispe_feb_16%2C_2017_manfredi_evening_handouts.pdf
Brian Pochini: http://www.ispeboston.org/files/ispe_feb_16%2C_2017_pochini_evening_handouts.pdf

LOCATION:
Biogen – Building 8 Auditorium
225 Binney Street, Cambridge, MA 02142
(Entrance at Building 9, 300 Binney Street)

SCHEDULE:
Afternoon Registration and Networking Reception:     3:00 PM – 3:30 PM
Afternoon Presentation:                                       3:30 PM – 5:30 PM
Evening Session Registration:                                5:30 PM – 6:00 PM
Evening Networking Reception:                              5:30 PM – 6:30 PM
Evening Presentation:                                          6:30 PM – 8:30 PM

EVENT INFORMATION:
You are invited to attend a live program presented by ISPE’s Critical Utility Community of Practice on the Critical Utilities of Water and Steam Systems. The program will be held at Biogen in Cambridge (venue kindly provided by Biogen). The event will feature an afternoon educational session, networking reception with appetizers and refreshments, followed by an evening presentation. You are invited to attend either or both of the sessions for one low price. Register now for this great program!

PROGRAM SUMMARY: 
Afternoon Session: The Current State of the Art in Pharmaceutical Water Systems

This session focuses on two important areas in Pharmaceutical Water: changes to USP <1231> and the evolution of rapid microbiological detection techniques and their impact on the biopharm industry.

The US Pharmacopoeia recently updated its non-binding guidance <1231> for the pharmaceutical industry. This session reviews the changes and updates to this important USP guidance document.  Since USP <1231> is a living document, there will also be discussions about future revisions to this document, including some additional elemental monitoring requirements.

Recently, there have been advances in rapidly detecting bacteria present in pure water systems.  These technological advances could a have widespread and positive impact in the biopharm industry as detection times change from 3 days to a few minutes.  But technologies and detection limits vary and implementation of this new technology may pose challenges.  Come to this session for an overview of the technologies in use, how they work, and learn about implementing a rapid microbiological detection system in a regulated environment.


PRESENTED BY:
Brian Hagopian, CPIP, Clear Water Consulting, Inc.
Joe Manfredi, GMP Systems, Inc.

Evening Session: Sampling of Pharmaceutical Water and Steam Systems
Sampling of compendial water and steam systems is required to demonstrate compliance with established process parameters and specifications.  When any step of the sampling process isn’t done properly, errors may be introduced and misrepresentative data can cost companies thousands if not millions of dollars by creating costly and unnecessary investigations and corrective actions. Sampling is an involved and complicated process and there is very little guidance on sampling – until now.  ISPE has recently published The ISPE Good Practice Guide: Sampling for Pharmaceutical Water, Steam, and Process Gases, the first definitive guide to sampling.  The guide provides expert guidance on all aspects of sampling.  Attend this session to learn from contributing authors of the guide, who will highlight some of the content of the Sampling Guide.  The information contained in this session, coupled with the Sampling Guide itself will become an indispensable tool to all users and custodians of water, steam, and process gas systems.

PRESENTED BY:
Joe Manfredi, GMP Systems, Inc.
Brian Pochini, CPIP, Sanofi Genzyme

WHO SHOULD ATTEND?
This session will provide valuable information to engineering, design, facilities, manufacturing, quality, validation, and regulatory functions as well as anyone who wants to learn more about water and steam systems.

SPEAKER AND MODERATOR:

Brian Hagopian, CPIP, Clear Water Consulting, Inc.

Brianis a degreed chemist from Colgate University and is the President of Clear Water Consulting, Inc. Brian brings over 35 years of experience as a high purity water subject matter expert, consultant, trainer, educator, and expert troubleshooter. Brian is an instructor at Worcester Polytechnic Institute’s Biomanufacturing Education and Training Center and is a Massachusetts certified instructor offering courses for industrial wastewater operators.

Brian has been an ISPE member since 1992 and has been an integral part of the growth of the Boston Area Chapter.  In 2015, Brian became one of six people to have received the Hank Moes Lifetime Achievement Award for significant contributions to the Boston Area Chapter and the life sciences industry.  Brian currently leads the Boston Area Chapter’s Student Development Committee where student membership has grown five-fold over the past several years.  Brian has been a member of the ISPE Critical Utilities COP Steering Committee for the past four years and has just finished leading a team of over 20 industry experts in publishing the ISPE Good Practice Guide on Sampling of Pharmaceutical Water, Steam, and Process Gases, which was released in December, 2016

SPEAKERS:

Joe Manfredi, GMP Systems, Inc.

Joe Manfredi is the President of GMP Systems where he has spent over 30 years designing systems, overseeing fabrication and installation, troubleshooting, training and providing consulting services for many of the world’s major pharmaceutical manufacturers. 

Joe was instrumental in establishing the Pharmaceutical Engineering Masters of Science Program at the New Jersey Institute of Technology, where he developed and taught many of the core graduate program courses and served as Chair of their Pharmaceutical Engineering Advisory Committee.

Joe is a graduate of Newark College of Engineering.  His expertise includes all areas of liquid processing with a special emphasis on water and steam systems.  Joe is a leading instructor of orbital welding technology for pharma and provides seminars in operator certification, orbital weld inspection and equipment calibration and service.

Joe was named ISPE Member of the Year in 1991 and Newark College of Engineering Distinguished Alumnus in 2004.  Joe has been a long time member of the ISPE CU CoP steering committee and led the group of subject matter experts to produce the water chapter in the Sampling Guide.

Brian Pochini, CPIP, Sanofi Genzyme

Brian is a principal Engineer working in Sanofi Specialty Care Operations Engineering.  Brian attained his Bachelor’s Degree in Chemical Engineering from Worcester Polytechnic Institute, his MBA from Bentley University, and attained his CPIP Credential from ISPE in 2012.

Brian has 20 years of practical experience within the biotechnology, membrane manufacturing and custom chemical industries.  Brian’s current responsibilities encompass many functions including HVAC, Critical Utilities, Process Engineering, Instrumentation and Controls, and Facility Design where he works with cross functional teams for multiple capital projects.

Brian is a former member of the ISPE C+Q Steering Committee and is currently the Chair of the ISPE Critical Utility COP Steering Committee.  Brian led the team of experts in producing the steam chapter for the Sampling Guide. 

MEETING MANAGERS:
Jim Taylor, Lean Biologix
Brian Hagopian, Clear Water Consulting, Inc.

REGISTRATION FEES:
Before 2/9/2017: 
Member $50.00  
Young Professional Members $20.00 
Non-Member $95.00**
ISPE Student Members: FREE

After 2/9/2017: 
Member: $60.00
Young Professional Members $30.00 
Non-Member: $115.00**
ISPE Student Members: FREE
**Non-members may only attend one program as a non-member**

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ISPE RE-SHOWING: Shifting Paradigms in Pharmaceutical Water and Steam
Date: 23 February 2017

Pre-registration is now closed.  Walk ins will be accepted at all site.  For questions, please contact ISPE Boston's office at (781) 647-4773

RE-SHOWING OF 2/16/2017 PROGRAM AT

Redhook Ale Brewery - Tour Gallery
1 Redhook Way, Portsmouth, NH 03801

AND WPI Biomanufacturing Education and Training Center at Gateway Park
50 Prescott Street, Worcester, MA 01605

AND Crowne Plaza Hotel 
801 Greenwich Ave, Warwick, RI 02886

REGISTRATION FEES:
Member FREE
Young Professional Members FREE
Non-Member FREE
ISPE Student Members: FREE

EVENT INFORMATION:
Join us on February 23, 2017 at the Redhook Ale Brewery in Portsmouth, NH; the WPI BETC at Gateway Park in Worcester, MA; or a location in Providence TBD for a re-showing of the program recorded at Biogen on February 16th. A networking reception, including refreshments and appetizers, will be hosted before the presentation at each location.

PROGRAM SUMMARY: Sampling of Pharmaceutical Water and Steam Systems
Sampling of compendial water and steam systems is required to demonstrate compliance with established process parameters and specifications.  When any step of the sampling process isn’t done properly, errors may be introduced and misrepresentative data can cost companies thousands if not millions of dollars by creating costly and unnecessary investigations and corrective actions. Sampling is an involved and complicated process and there is very little guidance on sampling – until now.  ISPE has recently published The ISPE Good Practice Guide: Sampling for Pharmaceutical Water, Steam, and Process Gases, the first definitive guide to sampling.  The guide provides expert guidance on all aspects of sampling.  Attend this session to learn from contributing authors of the guide, who will highlight some of the content of the Sampling Guide.  The information contained in this session, coupled with the Sampling Guide itself will become an indispensable tool to all users and custodians of water, steam, and process gas systems. 

PRESENTED BY:
Joe Manfredi, GMP Systems, Inc.
Brian Pochini, CPIP, Sanofi Genzyme

*See biographies below

WHO SHOULD ATTEND?
This session will provide valuable information to engineering, design, facilities, manufacturing, quality, validation, and regulatory functions as well as anyone who wants to learn more about water and steam systems.

SPEAKERS:
Joe Manfredi, GMP Systems, Inc.
Joe Manfredi is the President of GMP Systems where he has spent over 30 years designing systems, overseeing fabrication and installation, troubleshooting, training and providing consulting services for many of the world’s major pharmaceutical manufacturers. 

Joe was instrumental in establishing the Pharmaceutical Engineering Masters of Science Program at the New Jersey Institute of Technology, where he developed and taught many of the core graduate program courses and served as Chair of their Pharmaceutical Engineering Advisory Committee.

Joe is a graduate of Newark College of Engineering.  His expertise includes all areas of liquid processing with a special emphasis on water and steam systems.  Joe is a leading instructor of orbital welding technology for pharma and provides seminars in operator certification, orbital weld inspection and equipment calibration and service.

Joe was named ISPE Member of the Year in 1991 and Newark College of Engineering Distinguished Alumnus in 2004.  Joe has been a long time member of the ISPE CU CoP steering committee and led the group of subject matter experts to produce the water chapter in the Sampling Guide

Brian Pochini, CPIP, Sanofi Genzyme
Brian is a principal Engineer working in Sanofi Specialty Care Operations Engineering.  Brian attained his Bachelor’s Degree in Chemical Engineering from Worcester Polytechnic Institute, his MBA from Bentley University, and attained his CPIP Credential from ISPE in 2012.

Brian has 20 years of practical experience within the biotechnology, membrane manufacturing and custom chemical industries.  Brian’s current responsibilities encompass many functions including HVAC, Critical Utilities, Process Engineering, Instrumentation and Controls, and Facility Design where he works with cross functional teams for multiple capital projects.

Brian is a former member of the ISPE C+Q Steering Committee and is currently the Chair of the ISPE Critical Utility COP Steering Committee.  Brian led the team of experts in producing the steam chapter for the Sampling Guide. 

MEETING MANAGERS:
Jim Taylor, Lean Biologix
Brian Hagopian, Clear Water Consulting, Inc

 

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ISPE Young Professionals Committee Meeting
Date: 28 February 2017

This is a regular meeting of the Young Professionals Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 1 March 2017

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Annual Ski Trip
Date: 3 March 2017

Join ISPE for the Chapter's Annual Ski Trip on March 3, 2017 at Waterville Valley!

Pre-registration is now closed. If you are interested in attending and/or have any questions, please contact the ISPE Boston office at (781) 647-4773

Price Includes: Bus ride up and back, full day adult lift ticket, lunch voucher, buffet dinner, and a lot of fun with fellow ISPE members!

Note: Books of 4 Tickets are available for $340.  If you would like to purchase a Book, please fill out the FLYER and email or fax it to office@ispeboston.org or 781-647-7222.

Bus Departures: 
6:00 AM: from Newton Marriott - Rt. 128
6:40 AM: from Chateau Restaurant - Andover, MA
7:40 AM: from LL Bean, Concord - NH

Bus Returns: 4:30 PM from the hill to all Departure Sites (Concord, Andover, Newton)

Thanks to our Ski Trip Sponsors: 

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ISPE Product Show Committee Meeting
Date: 6 March 2017

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Student Development Committee Meeting
Date: 7 March 2017

This is a regular meeting for the Student Development Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 14 March 2017

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Presents: Continuous Manufacturing of Biopharmaceuticals
Date: 16 March 2017

PRESENTATIONS
Andre Walker, CPIP:  http://www.ispeboston.org/files/ispe_march_16_-_walker_handouts.pdf
Ketki Behere:  http://www.ispeboston.org/files/ispe_march_16_-_behere_handouts.pdf
Dr. Kathleen Mihlbachler:  http://www.ispeboston.org/files/ispe_march_16_-_mihlbachler_handouts.pdf

 

Takeda Pharmaceuticals
35 Landsdowne Street
Cambridge, MA 02139

SCHEDULE:

Registration and Networking Reception: 5:30 - 6:30 PM
Presentations: 6:30 - 8:30 PM
Q&A Session: 8:30 - 9:00 PM

EVENT INFORMATION:
Join us to learn about the latest developments in continuous manufacturing of biopharmaceuticals.  The event will feature a networking reception with hors d’oeuvres and refreshments including complimentary wine and beer. The main event includes three presentations followed by a panel discussion. Register now for this great program!

PROGRAM SUMMARY:
Continuous Biopharmaceutical Manufacturing: Challenges & Possibilities (Andre Walker, CPIP)
Continuous processing has transformed industries from petrochemicals to steel.  Endless case studies highlight how early adopters thrived while laggards, often leading firms in the industry, withered.  However, in the highly regulated space of the biopharmaceutical industry, impediments to adoption of this technology range from simple lack of vision and leadership, as well as significant economic and cultural factors.
Do these challenges conspire to make continuous manufacturing of biologics impractical, uneconomical, and simply too risky?  Andre’s presentation will address the hype, the key concerns, and present a possible future of continuous manufacturing of biologics.

Protein A Resin Lifetime Study: Evaluation of Protein A Resin Performance with a Model based approach in continuous capture (Ketki Behere)
Increased product yield at reduced cost and time is the driving force of many bio-manufacturing process improvements. Within the mAb platform, Protein A has played a critical role as an affinity moiety in traditional bind-and-elute (batch) chromatography.  As product demand and upstream titer continue to increase, continuous Protein A chromatography is being explored to keep up.
Although Protein A resins possess unique stability, degradation of resin particles takes place under continuous chromatographic conditions - mainly caused by caustic during the sanitization phase of chromatography. A modified shrinking core model (MSCM) has been employed to describe the mechanism and rate at which the degradation occurs. The kinetic model utilizes semi-empirical parameters estimated from breakthrough experiments for three distinct resins. This study proved the utility and functionality of the designed model, which can be built upon to design effective cleaning strategies.  In turn this should improve resin performance, and extend resin lifetime for continuous downstream processing.

Transforming Downstream Processing through Multi-Column Chromatography (Kathleen Mihlbachler)
Implementation of continuous processing in bio-manufacturing requires rethinking process chromatography and its equipment design. After years of development and many successes, continuously operating technologies are becoming part of the downstream processing (DSP) platform. This presentation will focus on multi-column technology including:

Basics of multi-column chromatography
Design requirements: Equipment and Automation
Optimization: Reducing the complexity in process and system design
Regulatory aspects and Performance Verification (PV)
Current developments and future trends

WHO SHOULD ATTEND?
Engineers, Scientists, and Quality Personnel who are interested in learning more about continuous manufacturing.

SPEAKERS:
Andre Walker, CPIP, Principal, Andre Walker Consulting, LLC
Andre Walker has over 30 years of experience providing engineering and technical support for manufacturing operations in consumer products, medical devices, and biotechnology. His biologics industry experience includes Director of Engineering and Manufacturing Sciences at several bio-manufacturing facilities ranging in scale from 2000 to 15,000 liters. He has held leadership roles in commercial cGMP facilities in the US and Denmark, and has served as Chairman of ISPE’s Board of Directors. Andre holds the Certified Pharmaceutical Industry Professional (CPIP) credential and is a recipient of the Hank Moes Lifetime Achievement Award.

Ketki Behere, PhD Candidate, Chemical Engineering, UMass Lowell
Ketki Behere’s research focusses on characterization of Protein A resin in downstream chromatography for purification of antibodies. She has worked at Lonza Biologics, Portsmouth as a co-op student in the Manufacturing Sciences and Technology (MSAT) group and as a Research Associate at Lonza Biologics, Hopkinton in the Downstream Process Development (PD) group. Previously she worked as Production executive in bio-manufacturing at Reliance Life Sciences (RIL), India. She has a Bachelor of Engineering degree in Biotechnology Engineering from Shivaji University, India.

Dr. Kathleen Mihlbachler, Global Director of Separation Development, LEWA Bioprocess
Dr. Mihlbachler has 20 years’ experiences in the field of process chromatography. In her current position as Global Director of Separation Development, she is responsible for the establishment of innovative technologies at LEWA Bioprocess, in particular for continuous processing applications in pharma. She is the principal designer/developer of the EcoPrime Twin platform by successfully leading the tech transfer of the ChromaCon’s CaptureSMB technology to the process scale. Dr. Mihlbachler has also been involved in hands-on training of engineers and scientists, as well as advisory roles for bachelor and PhD theses.  Dr. Mihlbachler presents technical and scientific results at international meetings and in peer-reviewed publications.
Prior to joining LEWA Bioprocess, Dr. Mihlbachler was Sr. Researcher for 10 years in the pharmaceutical industry. She was involved in the development and scale-up of purification/separation processes for numerous biologic compounds, peptides and proteins, implementing continuous processes at BMS, Eli Lilly and Pfizer. She has taught undergraduate courses in chemical and biomedical engineering at New Jersey Institute of Technology.  She also lead process chromatographic workshops (Prep Symposium) for more than 10 years.

MEETING MANAGERS:
Dan Pratt, Takeda Pharmaceuticals
Jack Campion, The Hart Companies

REGISTRATION FEES
Before 3/9/2017:
Member $50.00  
Young Professional Members $20.00 
Non-Member $95.00
ISPE Student Members: FREE

After 3/9/2017:
Member: $60.00
Young Professional Members $30.00 
Non-Member: $115.00
ISPE Student Members: FREE

Thank you to our Sponsor:

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ISPE INTERPHEX Bus #1
Date: 21 March 2017

Registration is now closed for this event. If you have any questions please contact the office at 781-647-4773 or office@ISPEBoston.org. 

Traveling to INTERPHEX from the New England Area?
Take the INTERPHEX Bus
Roundtrip Shuttle Bus Service for Just $10!

Tuesday, March 21, 2017
There are 2 separate routes: A and B. Please select the box for the stop where you will be boarding and note that the times listed are DEPARTURE TIMES. Please allow enough time to arrive, park your car, and board the bus.

Return trip departs from the Jacob K. Javits Center in NYC at 6:00 pm on Tuesday, March 21.

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ISPE INTERPHEX Bus #2
Date: 22 March 2017

Registration is now closed for this event. If you have any questions please contact the office at 781-647-4773 or office@ISPEBoston.org. 

Traveling to INTERPHEX from the New England Area?
Take the INTERPHEX Bus
Roundtrip Shuttle Bus Service for Just $10!

Wednesday, March 22, 2017
There are 2 separate routes: A and B. Please select the box for the stop where you will be boarding and note that the times listed are DEPARTURE TIMES. Please allow enough time to arrive, park your car, and board the bus.

Return trip departs from the Jacob K. Javits Center in NYC at 5:30 pm on Wednesday, March 22.

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ISPE Student Plant Tour of Sanofi Genzyme
Date: 27 March 2017

Registration is now closed.  Should you have any questions, please contact (781) 647-4773 or office@ispeboston.org

Free Student Plant Tour of Sanofi Genzyme

Monday, March 27, 2017
3:00 pm to 5:00 pm

3-4 pm Presentation
4-5 pm Plant Tour

The ISPE Boston Area Chapter Student Development Committee is proud to sponsor a plant tour of Sanofi Genzyme. This event will feature an introductory presentation and a tour of this state-of-the-art manufacturing facility. This exclusive event is limited to 25 guests so register now!

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ISPE Student Plant Tour of uniQure
Date: 28 March 2017

Registration is now closed.  Should you have any questions, please contact (781)647-4773 or office@ispeboston.org

Free Student Plant Tour of uniQure

Tuesday, March 28, 2017
3:00 pm to 5:00 pm

The ISPE Boston Area Chapter Student Development Committee is proud to sponsor a plant tour in collaboration with uniQure. This event will feature an introductory presentation by uniQure, a tour of their state-of-the-art manufacturing facility, and a question & answer session. This exclusive event is limited to 50 guests so register now!

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ISPE Young Professionals Committee Meeting
Date: 28 March 2017

This is a regular meeting of the Young Professionals Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE RE-SHOWING: Continuous Manufacturing
Date: 30 March 2017

Pre-registration is closed, but walk-ins will be accepted onsite. If you have any questions, please contact the office at office@ispeboston.org or 781-647-4773.

Redhook Ale Brewery - Tour Gallery
1 Redhook Way, Portsmouth, NH 03801

AND WPI Biomanufacturing Education and Training Center at Gateway Park
50 Prescott Street, Worcester, MA 01605

AND Doherty's Ale House
30 Jefferson Blvd, Warwick, RI 02888

REGISTRATION FEES:
Member FREE
Young Professional Members FREE
Non-Member FREE
ISPE Student Members: FREE

EVENT INFORMATION:
Join us on March 30, 2017 at the Redhook Ale Brewery in Portsmouth, NH; the WPI BETC at Gateway Park in Worcester, MA; or at a location in Providence, RI, for a re-showing of the program recorded at Takeda Pharmaceuticals on March 16th. A networking reception, including refreshments and appetizers, will be hosted before the presentation at each location.

PROGRAM SUMMARY:
Continuous Biopharmaceutical Manufacturing: Challenges & Possibilities (Andre Walker, CPIP)
Continuous processing has transformed industries from petrochemicals to steel. Endless case studies highlight how early adopters thrived while laggards, often leading firms in the industry, withered. However, in the highly regulated space of the biopharmaceutical industry, impediments to adoption of this technology range from simple lack of vision and leadership, as well as significant economic and cultural factors.
Do these challenges conspire to make continuous manufacturing of biologics impractical, uneconomical, and simply too risky? Andre’s presentation will address the hype, the key concerns, and present a possible future of continuous manufacturing of biologics.

Protein A Resin Lifetime Study: Evaluation of Protein A Resin Performance with a Model based approach in continuous capture (Ketki Behere)
Increased product yield at reduced cost and time is the driving force of many biomanufacturing process improvements. Within the mAb platform, Protein A has played a critical role as an affinity moiety in traditional bind-and-elute (batch) chromatography. As product demand and upstream titer continue to increase, continuous Protein A chromatography is being explored to keep up.
Although Protein A resins possess unique stability, degradation of resin particles takes place under continuous chromatographic conditions - mainly caused by caustic during the sanitization phase of chromatography. A modified shrinking core model (MSCM) has been employed to describe the mechanism and rate at which the degradation occurs. The kinetic model utilizes semi-empirical parameters estimated from breakthrough experiments for three distinct resins. This study proved the utility and functionality of the designed model, which can be built upon to design effective cleaning strategies. In turn this should improve resin performance, and extend resin lifetime for continuous downstream processing.

Transforming Downstream Processing through Multi-Column Chromatography (Kathleen Mihlbachler)
Implementation of continuous processing in bio-manufacturing requires rethinking process chromatography and its equipment design. After years of development and many successes, continuously operating technologies are becoming part of the downstream processing (DSP) platform. This presentation will focus on multi-column technology including:
Basics of multi-column chromatography
Design requirements: Equipment and Automation
Optimization: Reducing the complexity in process and system design
Regulatory aspects and Performance Verification (PV)
Current developments and future trends

WHO SHOULD ATTEND?
Engineers, Scientists, and Quality Personnel who are interested in learning more about continuous manufacturing.

SPEAKERS:
Andre Walker, CPIP, Principal, Andre Walker Consulting, LLC
Andre Walker has over 30 years of experience providing engineering and technical support for manufacturing operations in consumer products, medical devices, and biotechnology. His biologics industry experience includes Director of Engineering and Manufacturing Sciences at several bio-manufacturing facilities ranging in scale from 2000 to 15,000 liters. He has held leadership roles in commercial cGMP facilities in the US and Denmark, and has served as Chairman of ISPE’s Board of Directors. Andre holds the Certified Pharmaceutical Industry Professional (CPIP) credential and is a recipient of the Hank Moes Lifetime Achievement Award.

Ketki Behere, PhD Candidate, Chemical Engineering, UMass Lowell
Ketki Behere’s research focusses on characterization of Protein A resin in downstream chromatography for purification of antibodies. She has worked at Lonza Biologics, Portsmouth as a co-op student in the Manufacturing Sciences and Technology (MSAT) group and as a Research Associate at Lonza Biologics, Hopkinton in the Downstream Process Development (PD) group. Previously she worked as Production executive in bio-manufacturing at Reliance Life Sciences (RIL), India. She has a Bachelor of Engineering degree in Biotechnology Engineering from Shivaji University, India.

Dr. Kathleen Mihlbachler, Global Director of Separation Development, LEWA Bioprocess
Dr. Mihlbachler has 20 years’ experiences in the field of process chromatography. In her current position as Global Director of Separation Development, she is responsible for the establishment of innovative technologies
at LEWA Bioprocess, in particular for continuous processing applications in pharma. She is the principal  designer/developer of the EcoPrime Twin platform by successfully leading the tech transfer of the ChromaCon’s CaptureSMB technology to the process scale. Dr. Mihlbachler has also been involved in hands-on training of engineers and scientists, as well as advisory roles for bachelor and PhD theses. Dr. Mihlbachler presents technical and scientific results at international meetings and in peer-reviewed publications.
Prior to joining LEWA Bioprocess, Dr. Mihlbachler was Sr. Researcher for 10 years in the pharmaceutical industry. She was involved in the development and scale-up of purification/separation processes for numerous biologic compounds, peptides and proteins, implementing continuous processes at BMS, Eli Lilly and Pfizer. She has taught undergraduate courses in chemical and biomedical engineering at New Jersey Institute of Technology. She also lead process chromatographic workshops (Prep Symposium) for more than 10 years.

MEETING MANAGERS:
Dan Pratt, Takeda Pharmaceuticals
Jack Campion, The Hart Companies

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ISPE Product Show Committee Meeting
Date: 3 April 2017

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Student Development Committee Meeting
Date: 4 April 2017

This is a regular meeting for the Student Development Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 4 April 2017

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 5 April 2017

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Young Professionals Spring Event at Meadhall
Date: 6 April 2017

Join ISPE Young Professionals for our Spring Networking Event at Meadhall in Cambridge! Enjoy delicious snacks and an extensive and eclectic beer menu while getting to know fellow industry young professionals in one of Kendall Square’s iconic pubs.

When: 6 – 9 PM on Thursday, April 6, 2017

Where: Meadhall, 4 Cambridge Center, Cambridge MA 02142

Parking availability: Street Parking, Validated parking for Kendall Center Green Garage after 6 PM

Cost: $20 for ISPE members, $25 for non-Members

Please note that the entry fee covers the cost of food only. Alcoholic beverages are not included and may be purchased at the bar.

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ISPE 2017 Student Poster Contest
Date: 13 April 2017

Want to Show Off Your Work and Win $500.00? Register to Compete in the:

 

ISPE Boston Area Chapter
ANNUAL STUDENT POSTER CONTEST
on Thursday, April 13, 2017

Two winning student posters, one each from the graduate and undergraduate categories will receive a $500 cash prize and a FREE TRIP to compete at the International Student Poster Competition at ISPE’s Annual Meeting in San Diego, CA on October 28-November 1, 2017. Winners of the International competition receive cash awards and have the opportunity to publish their materials in ISPE's Pharmaceutical Engineering magazine, as well as other Chapter/Affiliate publications. 

Pre-Registration is required and you must be a member of the Boston Area Chapter of ISPE to participate.  Join ISPE at www.ispe.org/join-or-renew .

Cost:
Free

Location:
WPI’s Biomanufacturing Education and Training Center (BETC)
50 Prescott Street, Worcester, MA

Registration Deadline:
April 6, 2017 at noon

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Single Use Manufacturing: A Preview of the ISPE Guidance Document
Date: 13 April 2017

Presentations 
Pietro Perrone:  
http://www.ispeboston.org/files/ispe_april_13_-_perrone.pdf
Sally Kline:  http://www.ispeboston.org/files/ispe_april_13_-_kline.pdf
Jillian Willard:  http://www.ispeboston.org/files/ispe_april_13_-_willard.pdf

 

 

WPI – BETC at Gateway Park
50 Prescott Street
Worcester, MA 01605

EVENT INFORMATION:
Dive into the contents of ISPE’s Guidance Document. At this event you’ll hear different perspectives of Single Use Manufacturing and the importance each aspect of single use design has to different individuals. This event is generously hosted by WPI-BETC and will start with a networking reception with hors d’oeuvres and refreshments, Register now for this great program! 

PROGRAM SUMMARY:
The session provides a preview of ISPE’s Good Practice Guide to Single-Use Technology, provide insight into how it was generated, what challenges the authors faced, and solutions they developed. The presentation will highlight successes that can occur when applying this technology, and guidance, in the manufacturing processes. Participants will also learn about different perspectives of the document from a material scientist and an end user and how the guidance is important to each of them.

WHO SHOULD ATTEND?
Anyone associated and concerned with the quality and consistency of products produced with single use manufacturing technologies. 

SPEAKERS:
Pietro Perrone, Product Surveillance Lead Engineer, GE Healthcare
Pietro is a Professional Engineer registered in Massachusetts with degrees in Chemical Engineering from Tufts University and in Biomedical Engineering and Biotechnology from the University of Massachusetts. Pietro has more than 20 years of purification/separation technology experience in process development/optimization, equipment scale-up, and project management. Pietro chaired of the Disposables Community of Practice and is currently on its Steering Committee. He is a member of the Pharmaceutical Engineering Committee and an Editorial Reviewer for Pharmaceutical Engineering Magazine. As part of his activity with the Boston Chapter of ISPE, he is the Industry Advisor to the Tufts University Student Chapter. 

Sally Kline, Director of Process Development - Materials Science, Amgen
Sally joined Amgen in 2011 as a plastics subject matter expert specializing in Single Use Technology (SUT) design, commercialization, and Extractables & Leachables (E&L) topics. She has extensive experience in biotechnology, polymers and chemical industries focusing on R&D, manufacturing and supply chain. In her role, Sally serves as an industry thought leader and active member for consensus standards and industry trade organizations including Biophorum Operations Groups (BPOG), ASTM E-55, ACS, ISPE, and ELSIE. Sally received a B.S in Chemistry from Baldwin Wallace College, a M.S and Ph.D in Macromolecular Sciences from Case Western Reserve University, and completed a Post-Doctorate Fellowship at the Max Planck Institut fur Festkorperforshung, Germany. 

Jillian Willard, Senior Process Engineer - Manufacturing Sciences and Technology, Sanofi
Jillian has a Chemical Engineering degree from Tufts University. Jillian has more than 12 years of experience in validation, manufacturing technical support, and facility design/startup. She recently worked on a team tasked with the process and equipment design for a commercial scale biologics purification facility, including the selection and implementation of single use technology. Jillian is also an adjunct instructor at WPI’s Biomanufacturing Education and Training Center and served on the ISPE Boston Chapter Board of Directors for four years.

MEETING MANAGERS: 
Brody Stara, Amgen 
Dan Mardirosian, WPI

REGISTRATION FEES
Before 4/6/2017:
Members, $50.00  
Young Professional Members, $20.00 
Non-Members, $95.00
Student Members, FREE

After 4/6/2017:
Members, $60.00
Young Professional Members $30.00 
Non-Members, $115.00
Student Members, FREE

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ISPE RE-SHOWING: Single Use Manufacturing: A Preview of the ISPE Guidance Document
Date: 20 April 2017

Pre-registration is closed.  Walk-ins are welcome!  Contact office@ispeboston.org or (781) 647-4773 with questions and/or concerns.

RE-SHOWING OF APRIL 13th PROGRAM AT 

Redhook Ale Brewery – Tour Gallery 
1 Redhook Way, Portsmouth, NH 03801

AND AT

The Hart Companies
800 Scenic View Drive, Cumberland, RI 02864

EVENT INFORMATION: 
Join us on April 20, 2017 at the Redhook Ale Brewery in Portsmouth, NH or at The Hart Companies in Cumberland, RI, for a re-showing of the program recorded at WPI on April 13th. A networking reception, including refreshments and appetizers, will be hosted before the presentation at each location.

PROGRAM SUMMARY: 
The session provides a preview of ISPE’s Good Practice Guide to Single-Use Technology, provide insight into how it was generated, what challenges the authors faced, and solutions they developed. The presentation will highlight successes that can occur when applying this technology, and guidance, in the manufacturing processes. Participants will also learn about different perspectives of the document from a material scientist and an end user and how the guidance is important to each of them.

WHO SHOULD ATTEND?: 
Anyone associated and concerned with the quality and consistency of products produced with single use manufacturing technologies.

SPEAKERS: 
Pietro Perrone, Product Surveillance Lead Engineer, GE Healthcare 
Pietro is a Professional Engineer registered in Massachusetts with degrees in Chemical Engineering from Tufts University and in Biomedical Engineering and Biotechnology from the University of Massachusetts. Pietro has more than 20 years of purification/separation technology experience in process development/optimization, equipment scale-up, and project management. Pietro chaired of the Disposables Community of Practice and is currently on its Steering Committee. He is a member of the Pharmaceutical Engineering Committee and an Editorial Reviewer for Pharmaceutical Engineering Magazine. As part of his activity with the Boston Chapter of ISPE, he is the Industry Advisor to the Tufts University Student Chapter. 

Sally Kline, Director of Process Development - Materials Science, Amgen 
Sally joined Amgen in 2011 as a plastics subject matter expert specializing in Single Use Technology (SUT) design, commercialization, and Extractables & Leachables (E&L) topics. She has extensive experience in biotechnology, polymers and chemical industries focusing on R&D, manufacturing and supply chain. In her role, Sally serves as an industry thought leader and active member for consensus standards and industry trade organizations including Biophorum Operations Groups (BPOG), ASTM E-55, ACS, ISPE, and ELSIE. Sally received a B.S in Chemistry from Baldwin Wallace College, a M.S and Ph.D in Macromolecular Sciences from Case Western Reserve University, and completed a Post-Doctorate Fellowship at the Max Planck Institut fur Festkorperforshung, Germany.

Jillian Willard, Senior Process Engineer - Manufacturing Sciences and Technology, Sanofi 
Jillian has a Chemical Engineering degree from Tufts University. Jillian has more than 12 years of experience in validation, manufacturing technical support, and facility design/startup. She recently worked on a team tasked with the process and equipment design for a commercial scale biologics purification facility, including the selection and implementation of single use technology. Jillian is also an adjunct instructor at WPI’s Biomanufacturing Education and Training Center and served on the ISPE Boston Chapter Board of Directors for four years.

 

MEETING MANAGERS: 
Brody Stara, Amgen 
Dan Mardirosian, WPI

 

REGISTRATION FEES
Before 4/13/2017:
Member $20.00  
Young Professional Members $5.00 
Non-Member $45.00
ISPE Student Members: FREE

After 4/13/2017:
Member: $30.00
Young Professional Members $10.00 
Non-Member: $55.00
ISPE Student Members: FREE

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ISPE Young Professionals Committee Meeting
Date: 25 April 2017

This is a regular meeting of the Young Professionals Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE 25th Anniversary Gala
Date: 27 April 2017

Missed the Gala or just want to see the Anniversary Video again? Here it is! 

 

Due to an overwhelming response, registration for this event is closed. If you have any questions contact the office at office@ISPEBoston.org or 781-647-4773

Join your friends, colleagues, and fellow chapter members in commemorating the 25th Anniversary of the ISPE Boston Area Chapter with a gala cocktail reception and sit-down dinner  at the InterContinental Hotel in Boston. Celebrate this milestone by enjoying keynote speakers, entertainment, and socializing with friends and colleagues. Don’t miss this quarter century party!

Thursday, April 27, 2017

6:00–7:00 p.m. Cocktail Reception
7:00–8:00 p.m. Dinner
8:00–9:00 p.m. Keynote Address
9:00–10:30 p.m. Entertainment & Networking


 Sponsorships are SOLD OUT!

Email office@ispeboston.org to be added to the sponsorship waitlist.

 


 

Thank you to our gala sponsors:

 

Platinum

A/Z Corporation
Azzur Consulting
DPS
Hyde Engineering
Masy Bioservices
Perkins+Will
Superior Controls
The Hart Companies
Ultrafiltronics
ValSource, LLC

Gold

Albireo Energy
Boston Analytical
Columbia Construction Company
Commissioning Agents, Inc.
Commodore Builders
Cotter Brothers Corp
CRB
DPR Construction
E-Volve Systems
RW Sullivan Engineering
Sartorius Stedim NA Inc.
Sentinel Process Systems, Inc
Sentrol, Inc.
SPEC Process Engineering & Construction
Total Facility Solutions

Silver

AES Clean Technology, Inc.
Hargrove Life Sciences
Northeast Engineering
PendoTECH
SNC Lavalin

Bronze

Brooks Instrument
Festo Corporation
Prudential Cleanroom Services
Watson Marlow, Inc.

 

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ISPE Product Show Committee Meeting
Date: 1 May 2017

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Student Development Committee Meeting
Date: 2 May 2017

This is a regular meeting for the Student Development Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 3 May 2017

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Spring Golf Tournament
Date: 8 May 2017

General Sponsorship available. Individual Player and Foursome registration has closed.  Please contact (781) 647-4773 or office@ispeboston.org with questions.  

Get ready for Spring Golf! Register today for golfing, lunch and dinner with fellow colleagues.

Interested in a Foursome or a Sponsorship? Click here for the flyer and registration form. Use the online form for single registrations.

SCHEDULE:
10:45 AM - 11:45 PM Registration and Buffet Lunch 
12:00 PM -Shotgun Start – Scramble Format 
5:30 PM - Reception/Cocktails/Buffet Dinner

COST:
$700 Foursome/$200 Player
Lunch, Dinner and Golf are included for each player

LOCATION:
Ledgemont Country Club, Seekonk, MA 02271

Please contact the office at (781) 647-4773 if you have any questions about this event.

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ISPE Board of Directors Meeting
Date: 9 May 2017

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Mentoring Meeting
Date: 16 May 2017

Initial Kick-Off Meeting For Mentoring Program

This is an invitation-only pilot program. If you would like to have more information about upcoming Mentoring programs email the office at office@ISPEBoston.org.

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ISPE & PDA Joint Presentation - Validation: The Bridge Between Engineering & Quality Assurance
Date: 17 May 2017

 

Presentations:
http://www.ispeboston.org/files/ispe_pda_may_17_presentation_-_poeckh.pdf
http://www.ispeboston.org/files/ispe_pda_may_17_presentation_-_stanovich.pdf

ISPE Boston Area Chapter and the PDA New England Chapter are pleased to reunite again to present May’s educational event. We’ve secured two excellent speakers who will help us understand what’s needed to bring Engineers and Quality professionals together. Register now for this one of a kind opportunity to meet, exchange ideas and network with a much larger industry cross section.

SCHEDULE:

Registration and Networking Reception: 5:30 - 6:30 PM
Dinner: 6:30 - 7:00 PM
Presentations and Q&A Session: 7:00 - 8:45 PM
Networking: 8:45 - 9:00 PM

PROGRAM SUMMARY:

The Role and Purpose of Data - Before, During and After Qualification (Sylvan Poeckh)

Computers and data have become ubiquitous in manufacturing technology and in the science of validation. This presentation will use controlled storage and monitoring as a primary example to discuss and examine:

The prevalence of data and analytics in equipment design and manufacturing Leveraging available data to make better decisions toward purchasing, qualification and operation How validation and maintaining compliance are reliant on data integrity and quality How data and qualification provide a bridge between design and implementation The importance of robust data management systems for data monitoring and retention

Effectively Integrating the Concepts and Principles of Quality by Design (QbD) and QRM into the Life Cycle of Manufacturing Systems (Paul Stanovich)

This presentation will demonstrate how to implement the ASTM E2500 standard as a framework for the specification and design and verification of systems, with a focus on early involvement of the quality and validation units throughout the requirements definition and design phases of systems in order to ensure product quality and patient safety. The presentation will also show the effective use of design review and risk assessment to improve system design and formulate a verification strategy based on SME input. With this approach, true quality oversight involves much more SME level interaction than simply review and signature approval.

SPEAKERS:

Sylvan Poeckh is the Director of Validation for the Pennsylvania branch of Masy BioServices. He has worked in the pharma/biotech industry for over 22 years, with the past 15 years in a validation services role. His validation experience includes qualification and project management for numerous global Fortune 500 companies. Notable examples include Building Automation Systems, Distributed Control Systems for filling and packaging lines, data logging systems, and hundreds of environmentally controlled chambers. Sylvan is a Bachelor of Science in Information Systems degree candidate at Albright College.

Paul Stanovich is the Managing Partner and Senior Consultant at Process Design Solutions (PDS) and PDS Sandbox. Paul has over 20+ years of engineering consulting and executive level management experience at multiple global Engineering and Validation companies successfully delivering professional services to the pharmaceutical, biotech, and medical device industries. The PDS companies provide process and automation engineering, QbD/QRM, process/product development/design solutions for Single Use Technology (SUT) end users and suppliers alike. Paul is an expert in the development, execution, management of engineering/design, commissioning, qualification and validation strategies, plans, and programs. Paul also has an extensive experience and expertise in the implementation of current and new industry trends and best practices such as ASTM E2500, GAMP 5, ICH Q8, Q9, and Quality by Design (QbD) in engineering.

MEETING MANAGERS:

Michael Levesque, GE Healthcare
Brian Hagopian, Clear Water Consulting, Inc.
Howard Sneider, CRB

REGISTRATION FEES:

Before 5/10/2017:
ISPE Member $75.00
ISPE Young Professional Members $35.00
Non-Member $95.00
ISPE Student Members: FREE

After 5/10/2017:
ISPE Member $115.00
ISPE Young Professional Members $45.00
Non-Member $135.00
ISPE Student Members: FREE

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ISPE Young Professionals Committee Meeting
Date: 23 May 2017

This is a regular meeting of the Young Professionals Committee.  If you have any questions, please call the office at 781-647-4773.

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RE-SHOWING, Redhook: Validation: The Bridge Between Engineering & Quality Assurance
Date: 23 May 2017

Pre-registration is now closed.  Walk-ins welcome!  Please contact office@ispeboston.org or (781) 647-4773 with questions.

 

RE-SHOWING OF MAY 17th PROGRAM AT 

Redhook Ale Brewery - Alemaker's Hall
1 Redhook Way, Portsmouth, NH 03801

 

EVENT INFORMATION
Register now for this re-showing of the May 17th event recorded at the Hilton Boston/Woburn, hosted at Redhook Ale Brewery in Portsmouth, NH. A networking reception, including refreshments and appetizers, will occur before the presentation.

 

PROGRAM SUMMARY: 
The Role and Purpose of Data - Before, During and After Qualification (Sylvan Poeckh) 
Computers and data have become ubiquitous in manufacturing technology and in the science of validation.  This presentation will use controlled storage and monitoring as a primary example to discuss and examine:
-  The prevalence of data and analytics in equipment design and manufacturing  
-  Leveraging available data to make better decisions toward purchasing, qualification and operation 
-  How validation and maintaining compliance are reliant on data integrity and quality  
-  How data and qualification provide a bridge between design and implementation 
-  The importance of robust data management systems for data monitoring and retention 

Effectively Integrating the Concepts and Principles of Quality by Design (QbD) and QRM into the Life Cycle of Manufacturing Systems (Paul Stanovich) 
This presentation will demonstrate how to implement the ASTM E2500 standard as a framework for the specification and design and verification of systems, with a focus on early involvement of the quality and validation units throughout the requirements definition and design phases of systems in order to ensure product quality and patient safety. The presentation will also show the effective use of design review and risk assessment to improve system design and formulate a verification strategy based on SME input. With this approach, true quality oversight involves much more SME level interaction than simply review and signature approval.

 

WHO SHOULD ATTEND? 
This educational session will be of great value to individuals who hold GxP relevant roles in Manufacturing, Engineering, Quality and Validation. 

 

SPEAKERS
Sylvan Poeckh is the Director of Validation for the Pennsylvania branch of Masy BioServices. He has worked in the pharma/biotech industry for over 22 years, with the past 15 years in a validation services role. His validation experience includes qualification and project management for numerous global Fortune 500 companies. Notable examples include Building Automation Systems, Distributed Control Systems for filling and packaging lines, data logging systems, and hundreds of environmentally controlled chambers. Sylvan is a Bachelor of Science in Information Systems degree candidate at Albright College. 

Paul Stanovich is the Managing Partner and Senior Consultant at Process Design Solutions (PDS) and PDS Sandbox. Paul has over 20+ years of engineering consulting and executive level management experience at multiple global Engineering and Validation companies successfully delivering professional services to the pharmaceutical, biotech, and medical device industries. The PDS companies provide process and automation engineering, QbD/QRM, process/product development/design solutions for Single Use Technology (SUT) end users and suppliers alike. Paul is an expert in the development, execution, management of engineering/design, commissioning, qualification and validation strategies, plans, and programs. Paul also has an extensive experience and expertise in the implementation of current and new industry trends and best practices such as ASTM E2500, GAMP 5, ICH Q8, Q9, and Quality by Design (QbD) in engineering. 

 

PROGRAM MANAGERS: 
Michael Levesque, GE Healthcare 
Brian Hagopian, Clear Water Consulting, Inc. 
Howard Sneider, CRB

 

REGISTRATION FEES
Before 5/16/2017:
Member $20.00  
Young Professional Members $5.00 
Non-Member $45.00
ISPE Student Members: FREE

After 5/16/2017:
Member: $30.00
Young Professional Members $10.00 
Non-Member: $55.00
ISPE Student Members: FREE

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RE-SHOWING, Waters: Validation: The Bridge Between Engineering & Quality Assurance
Date: 25 May 2017

Pre-registration is now closed.  Walk-ins welcome!  Please contact office@ispeboston.org or (781) 647-4773 with questions.

 

RE-SHOWING OF MAY 17th PROGRAM AT 

Waters Corporation
34 Maple Street, Milford, MA 01757 

 

EVENT INFORMATION
Register now for this re-showing of the May 17th event recorded at the Hilton Boston/Woburn, hosted at Waters Corporation in Milford, MA. A tour of the facility (please plan to arrive well before 6:00 pm and bring a photo ID for security to participate), networking reception, will occur before the presentation.

 

PROGRAM SUMMARY: 
The Role and Purpose of Data - Before, During and After Qualification (Sylvan Poeckh) 
Computers and data have become ubiquitous in manufacturing technology and in the science of validation.  This presentation will use controlled storage and monitoring as a primary example to discuss and examine:
-  The prevalence of data and analytics in equipment design and manufacturing  
-  Leveraging available data to make better decisions toward purchasing, qualification and operation 
-  How validation and maintaining compliance are reliant on data integrity and quality  
-  How data and qualification provide a bridge between design and implementation 
-  The importance of robust data management systems for data monitoring and retention 

Effectively Integrating the Concepts and Principles of Quality by Design (QbD) and QRM into the Life Cycle of Manufacturing Systems (Paul Stanovich) 
This presentation will demonstrate how to implement the ASTM E2500 standard as a framework for the specification and design and verification of systems, with a focus on early involvement of the quality and validation units throughout the requirements definition and design phases of systems in order to ensure product quality and patient safety. The presentation will also show the effective use of design review and risk assessment to improve system design and formulate a verification strategy based on SME input. With this approach, true quality oversight involves much more SME level interaction than simply review and signature approval.

 

WHO SHOULD ATTEND? 
This educational session will be of great value to individuals who hold GxP relevant roles in Manufacturing, Engineering, Quality and Validation. 

 

SPEAKERS
Sylvan Poeckh is the Director of Validation for the Pennsylvania branch of Masy BioServices. He has worked in the pharma/biotech industry for over 22 years, with the past 15 years in a validation services role. His validation experience includes qualification and project management for numerous global Fortune 500 companies. Notable examples include Building Automation Systems, Distributed Control Systems for filling and packaging lines, data logging systems, and hundreds of environmentally controlled chambers. Sylvan is a Bachelor of Science in Information Systems degree candidate at Albright College. 

Paul Stanovich is the Managing Partner and Senior Consultant at Process Design Solutions (PDS) and PDS Sandbox. Paul has over 20+ years of engineering consulting and executive level management experience at multiple global Engineering and Validation companies successfully delivering professional services to the pharmaceutical, biotech, and medical device industries. The PDS companies provide process and automation engineering, QbD/QRM, process/product development/design solutions for Single Use Technology (SUT) end users and suppliers alike. Paul is an expert in the development, execution, management of engineering/design, commissioning, qualification and validation strategies, plans, and programs. Paul also has an extensive experience and expertise in the implementation of current and new industry trends and best practices such as ASTM E2500, GAMP 5, ICH Q8, Q9, and Quality by Design (QbD) in engineering. 

 

PROGRAM MANAGERS: 
Michael Levesque, GE Healthcare 
Brian Hagopian, Clear Water Consulting, Inc. 
Howard Sneider, CRB

 

REGISTRATION FEES
Before 5/18/2017:
Member $20.00  
Young Professional Members $5.00 
Non-Member $45.00
ISPE Student Members: FREE

After 5/18/2017:
Member: $30.00
Young Professional Members $10.00 
Non-Member: $55.00
ISPE Student Members: FREE

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ISPE Product Show Committee Meeting
Date: 5 June 2017

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Student Development Committee Meeting
Date: 6 June 2017

This is a regular meeting for the Student Development Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 7 June 2017

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 13 June 2017

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Brewing, Brettanomyces, and Biotech
Date: 14 June 2017

Presentations
Kate Steblenko:  http://www.ispeboston.org/files/ispe_june_14_presentation_-kate_steblenko.pdf
Ronn Friedlander:  http://www.ispeboston.org/files/ispe_june_14_presentation-_ronn_friedlander.pdf 

Springdale by Jack's Abby Brewing 
102 Clinton Street, Framingham, MA 01702

 

EVENT INFORMATION:
What can biotech learn from the brewing industry? It turns out, quite a bit! Join us to learn about the microbiology of beer and the interesting role yeast plays in brewing, as well as what lessons we can take away from the industry. The event will consist of brewery tours, presentations from two accomplished brewers with scientific backgrounds, and networking with food and beer. Please note: this is a 21+ venue

 

PROGRAM SUMMARY:
The Taming of the Brew (Ronn Friedlander) - In this increasingly hop-focused world of craft beer, yeast are the unsung heroes of brewing. Beyond just converting sugar into alcohol, yeast are responsible for a large proportion of beer's flavor. By going beyond the boundaries of domesticated brewing yeast, it may be possible to introduce a world of new flavors to beer. At Aeronaut Labs, we are collecting wild yeast to explore these flavors and develop new beers. Taming a wild yeast is no simple task, however, and this talk will focus on methods of collection and ensuring these yeasts are usable on an industrial scale.

When Good Bugs Go Bad: Detection of Beer Spoiling Microorganisms in a Mixed Fermentation Environment (Kate Steblenko) - Sour beer is a growing trend in the craft brewing industry, and many breweries are beginning to establish well respected, long term sour programs. Intentionally souring beers in a facility that also produces clean beer introduces an environment ripe for contamination. Both inoculating beer and preventing cross contamination require an active and evolving microbiology program. How contamination detection and prevention is accomplished in an environment that is intentionally saturated with spoilage microbes in a large brewery space.

 

WHO SHOULD ATTEND?
This session will provide valuable information to engineering, design, facilities, manufacturing, quality, validation and beer enthusiasts.

 

SPEAKERS AND BIOGRAPHIES:
Ronn Friedlander, Aeronaut Brewing Company 
Ronn Friedlander is cofounder and Chief Scientific Officer (CSO) of Aeronaut Brewing Company.  Ronn brings a vast academic background with a Biomedical Engineering degree from Rutgers, and a PhD in Medical Engineering and Medical Physics from MIT.  Ronn has taken his knowledge of cell culture to the industrial world heading up Aeronaut’s lab.

Kate Steblenko, Jack’s Abby Crafy Lagers 
Kate Steblenko is Jack Abby’s resident Beer Scientist in charge of maintaining their quality control program. Kate graduated from University of Vermont with a BS in Biochemistry and Molecular Biology and worked in a UMass/Harvard lab studying immunology to tuberculosis prior to joining Jack Abby’s in 2015.

 

MEETING MANAGERS: 
Eric Felz, Shire 
Patrick Govoni, DPS


REGISTRATION FEES
Before 6/7/2017:
Member $50.00  
Young Professional Members $20.00 
Non-Member $95.00
ISPE Student Members: FREE

After 6/7/2017:
Member: $60.00
Young Professional Members $30.00 
Non-Member: $115.00
ISPE Student Members: FREE

 

Thank you to our sponsor!:

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ISPE Young Professionals Softball Game
Date: 22 June 2017

Pre-registration for this event is now closed. Walk-ins are welcome!
Please contact office@ispeboston.org or (781) 647-4773 with questions.

Join ISPE Boston Young Professionals for a softball game! It's spring so let's get outside and have some fun! We will score some runs at the field and then head over to Jake n Joes for food and drinks! 

Sign up by June 14th with your shirt size to receive a team t-shirt! 

When: 5:45 - 9:30pm
Thursday June 22nd
Game Starts at 6pm 

Where: Lincoln Field, 122 Lincoln Street, Lexington, MA 
Jake n Joes, 70 Market Pl Drive, Waltham, MA
Free Parking Available 

Cost: $20 Young Professionals, $30 Members, $40 Non-members 

Registration includes softball game, team t-shirt, one drink ticket, and post-game food! T-shirts will be available for sign ups after June 14th, however sizes are not guaranteed.

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ISPE Young Professionals Committee Meeting
Date: 27 June 2017

This is a regular meeting of the Young Professionals Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Summer Social and Volunteer Appreciation Night
Date: 28 June 2017

SOLD OUT!  Please contact (781) 647-4773 or office@ispeboston.org with questions


Join the ISPE Boston Area Chapter for a Luau on Quincy Bay to celebrate the start of Summer and Volunteer Appreciation Night!

Wednesday, June 28, 2017
5:00 pm to 9:00 pm 
Squantum Yacht Club 
646 Quincy Shore Dr., Quincy, MA 02170

Admission: 
$15 ISPE Members 
$25 Non-Members 
ISPE Volunteers - FREE! - Email to office@ispeboston.org to RSVP

The event will feature: 
Raffle for Community Servings 
Music
BBQ Feast 
1 Drink ticket with admission 
Cash bar

Abundant street parking can be found along Quincy Shore Drive

 

Mahalo to our Summer Social Sponsors!
A/Z Corporation
Albireo Energy
Azzur Consulting
DPS
Hereva Consultants 
LJ Star 
Northeast Engineering 
RW Sullivan 
Sentrol, Inc. 
TRIA

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ISPE Product Show Committee Meeting
Date: 10 July 2017

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 11 July 2017

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Young Professionals Red Sox Game and Social
Date: 17 July 2017

Pre-registration for this event has closed.  Please contact office@ispeboston.org or (781) 647-4773 if you have any questions. 


Join the ISPE Boston Area Chapter Young Professionals in cheering on the Boston Red Sox as they take on the Toronto Blue Jays! We will be convening at Bullpen Kitchen + Tap beforehand for ticket pickup, as well as some pre-game food and drinks.

Availability is limited, so register today!

5:00 PM
Pre-Game Social at 
The Bullpen Kitchen + Tap
19 Yawkey Way, Boston, MA 02215

7:10 PM
Red Sox vs. Toronto Blue Jays

REGISTRATION FEES:
Young Professional Member $30.00
Member $50.00
Non-Member $75.00


Thank you to our sponsors!
Azzur Group
Integra Companies
Sequence, Inc.

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ISPE Educational Programs 2018 Season Planning Meeting
Date: 19 July 2017

Pre-registration for this event has closed.  Walk-ins welcomed!  Please contact (781) 647-4773 or office@ispeboston.org with questions. 


The Educational Program Committee would like YOUR help to finalize the educational program content for the upcoming Chapter year. Please join us on Wednesday, July 19th as the 2018 educational season is developed. We are looking for program managers both experience and new to join our team. 

Schedule 5:30 PM - 8:30 PM Dinner, planning the 2018 programming year, and brief committee meeting

Attendance and parking are free (we want your assistance) and food will be provided! 

ISPE Membership is required in order to participate in any Chapter Committee.  To become a member, click here and select the Boston Area Chapter.

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ISPE Young Professionals Committee Meeting
Date: 1 August 2017

This is a regular meeting of the Young Professionals Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Committee Meeting
Date: 2 August 2017

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Student Chapter Committee Strategic Planning Session
Date: 2 August 2017

Pre-registration is closed. Please call the office if you have any questions about attending 781-647-4773

Please join the Boston Area Chapter of ISPE to participate in a strategic planning meeting and workshop for our student chapters. Please RSVP using the button below. Call the office at 781-647-4773 with any questions. 

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ISPE Product Show Committee Meeting
Date: 7 August 2017

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 8 August 2017

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 9 August 2017

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Summer Golf Tournament
Date: 21 August 2017

SOLD OUT!  Please contact office@ispeboston.org or (781) 647-4773 with questions.


Take in panoramic waterfront views at this year's event at Kernwood Country Club in Salem, MA.  
Lunch, dinner and golf are included for each player.

 

LOCATION:
Kernwood Country Club
1 Kernwood Street
Salem, MA 01970

 

SCHEDULE
11:00 AM - Registration, Lunch and Driving Range 
12:30 PM - Shotgun Start – Scramble Format 
6:00 PM - Reception/Cocktails/Dinner

Thank you to our Sponsors:

Putting Contest:  Wise Construction
Hole-in-One:  Superior Controls
Closest to the Pin Men: DPS
Closest to the Pin Women:  Cotter Brothers Corp.
Longest Drive Men:  Azzur Group
Longest Drive Women:  TRIA
Straightest Drive Men:  Ultrafiltronics
Straightest Drive Women:  Erland Construction
Hole Sponsor:  A/Z Corporation
Hole Sponsor:  Albireo Energy
Hole Sponsor:  Azzur Group
Hole Sponsor:  BOND Brothers
Hole Sponsor:  Commodore Builders
Hole Sponsor:  Hyde Engineering + Consulting
Hole Sponsor:  M+W Group
Hole Sponsor:  PIDC Construction
Hole Sponsor:  R.W. Sullivan
Hole Sponsor:  Bowdoin Construction Corp. 
Hole Sponsor:  ValSource
Attendee Cart Gift:  Boston Analytical
Reception Sponsor:  AHA Engineers

Please contact (781) 647-4773 or office@ispeboston.org if you have questions.

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ISPE Summer Golf Tournament - DINNER ONLY
Date: 21 August 2017

Pre-registration for this dinner event is closed.  Walk-ins welcome.  Please contact (781) 647-4773 or office@ispeboston.org with questions.

Our Sponsorships and Foursomes are sold out for the Annual Summer Golf Tournament, but we still want you there! Please join us for a dinner reception and a chance to network with your ISPE peers while taking in waterfront views at this year's event at Kernwood Country Club in Salem, MA.   

LOCATION:
Kernwood Country Club
1 Kernwood Street
Salem, MA 01970

SCHEDULE
6:00 PM - Reception/Cocktails/Dinner





Thank you to our Sponsors
Putting Contest:  Wise Construction 
Hole-in-One:  Superior Controls 
Closest to the Pin Men: DPS 
Closest to the Pin Women:  Cotter Brothers Corp. 
Longest Drive Men:  Azzur Group 
Longest Drive Women:  TRIA 
Straightest Drive Men:  Ultrafiltronics 
Straightest Drive Women:  Erland Construction 
Hole Sponsor:  A/Z Corporation 
Hole Sponsor:  Albireo Energy 
Hole Sponsor:  Azzur Group 
Hole Sponsor:  BOND Brothers 
Hole Sponsor:  Commodore Builders 
Hole Sponsor:  Hyde Engineering + Consulting 
Hole Sponsor:  M+W Group 
Hole Sponsor:  PIDC Construction 
Hole Sponsor:  R.W. Sullivan 
Hole Sponsor:  Bowdoin Construction Corp. 
Hole Sponsor:  ValSource 
Attendee Cart Gift:  Boston Analytical 
Reception Sponsor:  AHA Engineers

Please contact (781) 647-4773 or office@ispeboston.org if you have questions.

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ISPE Product Show Committee Meeting
Date: 28 August 2017

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Geographic Outreach (GO) Committee Meeting
Date: 28 August 2017

This is a regularly scheduled GO Committee Meeting. If you have any questions please contact the office at office@ISPEBoston.org or 781-647-4773.

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ISPE Young Professionals Committee Meeting
Date: 29 August 2017

This is a regular meeting of the Young Professionals Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Committee Meeting
Date: 6 September 2017

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Young Professional's Boston Harbor Boat Cruise
Date: 7 September 2017

Pre-registration is now closed.  Walk-ins welcome!  Please contact (781) 647-4773 or office@ispeboston.org with questions

 

Join the ISPE Boston Area Chapter for our kick-off event of the season! New and returning members, young and old professionals are all welcome to enjoy in a night of socializing and networking with music as we tour the Boston Harbor waters.


This event is geared towards facilitating social and professional networking between people in the pharmaceutical, biotech, and life sciences fields. This is a great opportunity to meet other people from different areas of these exciting and diverse industries and get involved with the ISPE Boston Area Chapter. 


6:00 pm - Boarding
     Massachusetts Bay Lines, Inc.
     60 Rowes Wharf
     Boston, MA 02110
6:30 pm - Sailing
9:30 pm - Return

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ISPE Product Show Committee Meeting
Date: 11 September 2017

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 12 September 2017

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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Focused Trends from FDA: What are they focusing on during their inspection?
Date: 21 September 2017

Presentations
Jolly Bhatia:  http://www.ispeboston.org/files/membersonly/ispe_sept_21_presentation_-_jolly_bhatia.pdf
Mark Lookabaugh:  http://www.ispeboston.org/files/membersonly/ispe_sept_21_presentation_-_mark_lookabaugh.pdf 

Shire
Fortis Lecture Hall 
200 Shire Way 
Lexington, MA 02421


SCHEDULE:
4:30 - 5:15 PM Members Only Tours
5:30 - 6:30 PM Registration and Networking Reception
6:30 - 8:30 PM Presentations


EVENT INFORMATION
Attend a live program at Shire in Lexington, MA on the FDA's inspection trends and focuses featuring an ex-FDA inspector and an industry Quality representative. This program will feature a facility tour, networking reception including refreshments and a live Q&A session at the end of presentation. Register now to stay current on FDA inspection trends and be inspection-ready at all times!


Membership has its privileges!
This tour is open only to ISPE Members!  Please check-in at Fortis Lecture Hall at 200 Shire Way, Lexington and you will be given your tour group schedule.  Tours start at 4:30PM and the last tour leaves at 5:15PM.

 

PROGRAM SUMMARY
Staying up-to-date on the regulatory guidance and health authority expectations is critical for any GMP-regulated organization.  With fast growth in technology and changes in how organizations are run, it’s critical to understand the requirements for maintaining regulatory compliance.  In this event focused on the FDA, we will hear from both sides of the compliance dilemma: a Director of Quality Assurance in the industry, and an ex-FDA inspector.  Come to this event to find out the most current perspective on preparing for your inspection, and to learn about upcoming trends in FDA oversight.  Our speakers will participate in a joint Q&A after their presentations for discussion and to answer your questions.


WHO SHOULD ATTEND
Quality Engineers and Quality Assurance Professionals, Validation Engineers, Compliance Professionals, QC Microbiology and Contamination Control Professionals, and anyone responsible for maintaining inspection-readiness for their organization.

  

PART 1: Inspection Readiness – The Industry Perspective 

As more and more pharmaceutical companies move towards building their products around contract research, test, and manufacturing organizations, our industry must adapt our understanding of how to operate in compliance with FDA and global regulations when operations are not within our immediate control.  The first presentation of the evening, delivered by Jolly Bhatia, Senior Director of Supply Chain Quality Assurance at Alnylam Pharmaceutials, will focus on current trends in regulatory inspections from the perspective of a CMO-based quality organization.  Jolly will present a case study on inspection planning for a CMO-based organization, and will answer questions on the ever-changing regulatory landscape impacting them.

  

SPEAKER: 
Jolly Bhatia, Senior Diector, Quality Assurance, Alnylam Pharmaceuticals 
Jolly Bhatia currently works at Alynylam Pharmaceuticals as the Senior Director of Supply Chain Quality Assurance. His responsibilities include quality oversight of manufacturing and supply chain operations, starting from procurement of raw materials to delivery of product to the patient. In his more than 20 years of experience in the bio pharmaceutical industry, Jolly has worked with several internal and contract manufacturing sites, in validation and quality leadership roles, preparing for routine and Pre-Approval Inspections. 


PART 2: Regulatory Developments and Areas of Concern
The FDA continues to issue the most warning letters for rudimentary cGMP issues worldwide, but in this presentation Mark Lookabaugh (ex-FDA, Parexel Consulting) will focus on the most modern inspections trends and issues effecting FDA-regulated organizations.  Mark will discuss ongoing issues with data integrity, and provide his most current perspective on which guidance to follow to deal with those issues. Mark will also discuss the FDA’s program alignment initiative and how it may affect inspection schedules, turn-around times, as well as the effects of EU / FDA Mutual Recognition Initiative and Responsible Corporate Officer Doctrine.


SPEAKER
Mark Lookabaugh, Principal Consultant, PAREXEL Consulting 
Mark Lookabaugh, Principal Consultant, provides GMP and QSR auditing and consulting services to PAREXEL clients worldwide. Prior to joining PAREXEL, he served 30 years with the FDA.  His career included work as an Analytical Chemist in the New England District laboratory, specializing in pharmaceutical chemistry.  He performed Pre-Approval Inspections (PAIs) in the pharmaceutical and biotechnology industries in the US and overseas.  He also served for 8 years as a Compliance Officer in the New England District Office, processing FDA enforcement actions in the 6 New England States.  During this period, he managed several medical device cases and gained knowledge of the QSR and MDR regulations. In 2004, he was promoted to Director, Compliance Branch, with responsibility for oversight of all FDA enforcement activities in the New England District.  He has published scientific papers in the Journal of Chromatography, and is the recipient of several FDA awards. Mark received a BS degree (Chemistry) with high honors from Worcester Polytechnic Institute, Worcester, Massachusetts.


COST:
Early bird, register by 9/14/17
Members - $50
YP Members - $20
Nonmembers - $95
Student Members - FREE

After 9/14/17
Members -  $60
YP Members -  $30
Nonmembers - $115
Student Members - FREE


MEETING MANAGERS: 
Brijesh Patel, Shire 
James Hughes, Boston Technology Research

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ISPE Geographic Outreach (GO) Committee Meeting
Date: 25 September 2017

This is a regularly scheduled GO Committee Meeting. If you have any questions please contact the office at office@ISPEBoston.org or 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 25 September 2017

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Young Professionals Committee Meeting
Date: 26 September 2017

This is a regular meeting of the Young Professionals Committee.  If you have any questions, please call the office at 781-647-4773.

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Portsmouth Re-showing: Focused Trends from FDA: What are they focusing on during their inspection?
Date: 28 September 2017

Pre-registration for this event is now closed.  Walk-ins are welcome!  Please contact (781) 647-4773 or office@ispeboston.org if you have any questions.

Redhook Ale Brewery - Tour Gallery
1 Redhook Way, Portsmouth, NH 03801 


EVENT INFO
Register now for this re-showing of the September 21st event recorded at Shire!  A networking reception, including refreshments and appetizers, will occur before the presentations. 


PROGRAM SUMMARY
Staying up-to-date on the regulatory guidance and health authority expectations is critical for any GMP-regulated organization.  With fast growth in technology and changes in how organizations are run, it’s critical to understand the requirements for maintaining regulatory compliance.  In this event focused on the FDA, we will hear from both sides of the compliance dilemma: a Director of Quality Assurance in the industry, and an ex-FDA inspector.  


WHO SHOULD ATTEND
Quality Engineers and Quality Assurance Professionals, Validation Engineers, Compliance Professionals, QC Microbiology and Contamination Control Professionals, and anyone responsible for maintaining inspection-readiness for their organization.


PART 1:  Inspection Readiness - The Industry Perspective
Presented by:  Jolly Bhatia, Senior Director, Quality Assurance, Alnylam Pharmaceuticals


PART 2:  Regulatory Developments and Areas of Concern
Presented by:
 Mark Lookabaugh, Principal Consultant, PAREXEL Consulting 


PROGRAM SCHEDULE
5:30 PM - 6:30 PM, Registration and Networking Reception
6:30 PM - 8:30 PM, Presentations 
8:30 PM - 9:00 PM, Q&A


REGISTRATION FEES
Early bird, register by 9/21/17
Members - $20 
YP Members - $5 
Nonmembers - $45 
Student Members - FREE 

After 9/21/17 
Members - $30 
YP Members - $10 
Nonmembers - $55 
Student Members - FREE

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ISPE Annual Product Show and Educational Seminars
Date: 4 October 2017

Please note that this is the planned date for the 26th Annual Product Show!

Click here for the ISPE Product Show site

Click here to register for the ISPE Product Show

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ISPE Board of Directors Meeting
Date: 10 October 2017

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Committee Meeting
Date: 17 October 2017

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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Utilities not Included
Date: 19 October 2017

Northeastern University 
Egan Research Center 
120 Forsyth St  
Boston, MA 02115


SCHEDULE:
5:30 PM - 6:30 PM - Networking, Room 306 
6:30 PM - 9:00 PM - Presentations, Room 440

PROGRAM INFORMATION
Control of the manufacturing environment and utilities are critical elements of implementing a successful pharmaceutical manufacturing process. Engineers entering the pharmaceutical and biopharmaceutical industries can find excellent opportunities in the design and implementation of high-purity water an HVAC systemts. Process engineers should also have a working knowledge of the utility systems which support their porcesses. This workshop will provide students and young professionals with a basic understanding of the terminology and industry jargon associated with high-purity water and HVAC systems, as well as the purpose and function of the system components.


PRESENTATION ABSTRACTS:  
HVAC Systems One key of automation is understanding the process and understanding the cause and affect of our everyday actions. This presentation will review the basics of HVAC operation enabling attendees to understand the systems controlling the laboratory and production suite environments utilized for research and to manufacture product. This presentation is geared towards those with little to no facilities background or those in facilities who wish to review the very basic operation of HVAC systems serving critical environments. In addition, it will review the basics of the associated automation theory which allows the systems to operate and maintain personnel, equipment, and product requirements. Attendees will learn how their actions in one environment affects adjacent environments and what automation systems are in place in todays facilities to compensate for those actions to prevent personnel discomfort, ensure environmental safety, and maintain product requirements. 


High Purity Water Systems Water is the most commonly used material in the manufacture and purification of many biotech and pharmaceutical products as well as medical devices.  Water is used as an ingredient, a solvent, a diluent, a cleaner, and for many other purposes. We will start by focusing on the contaminants and impurities present in the incoming water supply and then focus on what needs to be removed based on the intended use of the water.   Attendees will learn about dozens of different water purification process and how they can be integrated to get the right water purity for the intended use. We will touch on different grades of water as identified by various pharmacopoeias and consensus standards (ASTM, CAP/CLSI, pharmaceutical, and microelectronics grades). Attendees will receive a broad overview of why different grades of water purity exist and, as time permits, we’ll spend time focusing on three important topics:  reverse osmosis, deionization, and bacteria.


SPEAKERS:
Jay Zaino is the former president and co-founder of GxP Automation, LLC which was acquired by Albireo Energy in 2015. Currently, Mr. Zaino is an independent consultant to the local Life Science market. He has over 26 successful years in engineering, software development, and validation strategies for critical automation systems serving the Life Science Industry. Mr. Zaino is a Past President of the Boston Chapter of ISPE and currently serves on the Scholarship Committee. Mr. Zaino is an industry leader in implementing new facility integration technologies, automation initiatives, and validation strategies for the pharmaceutical, biotech, and medical device markets.

Brian Hagopian, CPIP received his degree in chemistry from Colgate University a long time ago and is currently the President of Clear Water Consulting, Inc. Brian has over 35 years of design, manufacturing and operational experience with water purification systems and is a subject matter expert, consultant, trainer, educator, and expert troubleshooter helping clients solve complex operational problems, assess risks, address compliance observations, and document activities. Brian is an instructor at Worcester Polytechnic Institute’s Biomanufacturing Education and Training Center and is also certified by the Commonwealth of Massachusetts as an instructor offering courses for the training and licensing of industrial wastewater operators. Brian is a charter member and Past President of the Boston Area Chapter where he helped to build the foundation for the Boston Chapter’s highly successful Product Show, which has won two International awards for “Best Special Event” at ISPE Annual Meetings.  Brian ran point on the Product Show when it moved from Cambridge to Newton and was one of the people responsible for bringing the show to Gillette Stadium, where he ran the show for its first four years at Gillette.  Brian is one of 150 people worldwide to have attained the Certified Pharmaceutical Industry Professional (CPIP) certification.  Brian led several CPIP study groups that resulted in the Boston Chapter being home to about 50% of the world’s CPIP’s.  Brian is one of only eight people to have received the prestigious Hank Moes Lifetime Achievement Award for significant contributions to the Boston Area Chapter and the Life Sciences industry.  Brian has led the Boston Chapter’s Student Development Committee for the past six years and his efforts have brought growth and stability with student membership quadrupling and the number of student chapters doubling through these efforts.  Brian has also been an active member of the ISPE International Critical Utilities Community of Practice Steering Committee where he recently led a team of subject matter experts in the publication of a long overdue benchmark document: The ISPE Good Practice Guide on Sampling of Critical Utilities, which was published in December 2016.


COST
Early bird, register by 10/12/17 
Member - $50  
YP Member - $20  
Nonmember - $95  
Student Member - FREE 

After 10/12/17 
Member - $60 
YP Member - $30 
Nonmember - $115 
Student Member - FREE

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ISPE International Boston Training Event
Date: 23 October 2017 - 26 October 2017

A well-trained staff is critical to meeting global cGMP regulations. Training can mean the difference between successful operations and regulatory violations.

Our Courses:
* Have Measurable Learning Objectives
* Provide an In-Depth Understanding of "How" and "Why"
* Use Lectures, Group Exercises, Case Studies, and ISPE's Guidance Documents
* Provide You With Tangible "Take-A-Ways" For Immediate Application on the Job
* Leverage the Expertise of ISPE's Global Subject Matter Experts

To see more detail on the courses being offered in Boston, October 23-26 click on the buttons below.


DATE

TOPIC

SPEAKER

M/T
23-24 Oct

Applying the Biopharmaceutical Manufacturing Facilities Baseline® Guide Principles

Robert Warn

M/T
23-24 Oct

Cleaning Validation Principles

Becky Brewer

M/T
23-24 Oct

Pharmaceutical Water Generation

Gary Zoccolante

M/T/W
24-26 Oct

HVAC

Norm Goldschmidt

W/Th
25-26 Oct

Storage, Delivery and Qualification of Pharmaceutical Waters

Gary Zoccolante

W/Th
25-26 Oct

Facility Project Management in a Regulated Pharmaceutical Environment

Robert Perry













































Register today using the buttons below. Contact the International ISPE office at 813-960-2105 with any questions.

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ISPE Young Professionals Committee Meeting
Date: 24 October 2017

This is a regular meeting of the Young Professionals Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Fall Social and Costume Contest
Date: 26 October 2017

Join us on Thursday, October 26th at Clery's Bar & Restaurant in the Back Bay/South End of Boston for our Fall Social. This year's social will be a Costume Party! So dress up and be part of the fun. A costume contest will be held for the Best, Scariest and Most Creative costumes. The Social will also feature a 50/50 raffle to benefit The Jimmy Fund! Every attendee will receive a free drink ticket with registration.

Thank you to our Fall Social sponsors!

AHA Engineers
Albireo Energy
Azzur Group
Boston Analytical
DPS
Hereva Consultants
R.W. Sullivan

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ISPE Annual Meeting
Date: 29 October 2017 - 1 November 2017

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ISPE Geographic Outreach (GO) Committee Meeting
Date: 30 October 2017

This is a regularly scheduled GO Committee Meeting. If you have any questions please contact the office at office@ISPEBoston.org or 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 6 November 2017

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE How to Deal with Difficult People
Date: 8 November 2017

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ISPE Educational Programs Committee Meeting
Date: 9 November 2017

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 14 November 2017

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ISPE Geographic Outreach (GO) Committee Meeting
Date: 27 November 2017

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ISPE Young Professionals Committee Meeting
Date: 28 November 2017

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ISPE Product Show Committee Meeting
Date: 4 December 2017

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Committee Meeting
Date: 6 December 2017

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ISPE Single Use
Date: 7 December 2017

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ISPE Board of Directors Meeting
Date: 12 December 2017

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ISPE Geographic Outreach (GO) Committee Meeting
Date: 18 December 2017

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ISPE Educational Programs Committee Meeting
Date: 3 January 2018

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 8 January 2018

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 9 January 2018

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ISPE Monthly Education Program
Date: 18 January 2018

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ISPE New Year's Social
Date: 25 January 2018

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ISPE Geographic Outreach (GO) Committee Meeting
Date: 29 January 2018

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ISPE Young Professionals Committee Meeting
Date: 30 January 2018

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ISPE Product Show Committee Meeting
Date: 5 February 2018

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Committee Meeting
Date: 7 February 2018

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Young Professionals Event
Date: 8 February 2018

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ISPE Board of Directors Meeting
Date: 13 February 2018

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ISPE Monthly Education Program
Date: 15 February 2018

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ISPE Geographic Outreach (GO) Committee Meeting
Date: 26 February 2018

This is a regularly scheduled GO Committee Meeting. If you have any questions please contact the office at office@ISPEBoston.org or 781-647-4773.

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ISPE Young Professionals Committee Meeting
Date: 27 February 2018

This is a regular meeting of the Young Professionals Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Annual Ski Trip
Date: 2 March 2018

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ISPE Product Show Committee Meeting
Date: 5 March 2018

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Committee Meeting
Date: 7 March 2018

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 13 March 2018

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ISPE Monthly Education Program
Date: 15 March 2018

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ISPE Geographic Outreach (GO) Committee Meeting
Date: 26 March 2018

This is a regularly scheduled GO Committee Meeting. If you have any questions please contact the office at office@ISPEBoston.org or 781-647-4773.

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ISPE Young Professionals Committee Meeting
Date: 27 March 2018

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ISPE Product Show Committee Meeting
Date: 2 April 2018

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Committee Meeting
Date: 4 April 2018

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Young Professionals Event
Date: 5 April 2018

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ISPE Board of Directors Meeting
Date: 10 April 2018

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ISPE 2018 Student Poster Contest
Date: 12 April 2018

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ISPE Young Professionals Committee Meeting
Date: 24 April 2018

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ISPE Geographic Outreach (GO) Committee Meeting
Date: 30 April 2018

This is a regularly scheduled GO Committee Meeting. If you have any questions please contact the office at office@ISPEBoston.org or 781-647-4773.

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ISPE Educational Programs Committee Meeting
Date: 2 May 2018

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Young Professionals Event
Date: 3 May 2018

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ISPE Product Show Committee Meeting
Date: 7 May 2018

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 8 May 2018

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Spring Golf Tournament
Date: 14 May 2018

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ISPE Monthly Education Program
Date: 17 May 2018

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ISPE Geographic Outreach (GO) Committee Meeting
Date: 21 May 2018

This is a regularly scheduled GO Committee Meeting. If you have any questions please contact the office at office@ISPEBoston.org or 781-647-4773.

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ISPE Young Professionals Committee Meeting
Date: 29 May 2018

This is a regular meeting of the Young Professionals Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 4 June 2018

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Committee Meeting
Date: 6 June 2018

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 12 June 2018

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ISPE Monthly Education Program
Date: 21 June 2018

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ISPE Geographic Outreach (GO) Committee Meeting
Date: 25 June 2018

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ISPE Young Professionals Committee Meeting
Date: 26 June 2018

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ISPE Summer Social and Volunteer Appreciation Night
Date: 28 June 2018

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ISPE Product Show Committee Meeting
Date: 2 July 2018

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 10 July 2018

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE 2019 Educational Season Planning Meeting
Date: 18 July 2018

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ISPE Young Professionals Event
Date: 19 July 2018

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ISPE Geographic Outreach (GO) Committee Meeting
Date: 30 July 2018

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ISPE Young Professionals Committee Meeting
Date: 31 July 2018

This is a regular meeting of the Young Professionals Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Committee Meeting
Date: 1 August 2018

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 6 August 2018

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Summer Golf Tournament
Date: 13 August 2018

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ISPE Board of Directors Meeting
Date: 14 August 2018 - 15 August 2018

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 20 August 2018

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Geographic Outreach (GO) Committee Meeting
Date: 27 August 2018

This is a regularly scheduled GO Committee Meeting. If you have any questions please contact the office at office@ISPEBoston.org or 781-647-4773.

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ISPE Young Professionals Committee Meeting
Date: 28 August 2018

This is a regular meeting of the Young Professionals Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Committee Meeting
Date: 5 September 2018

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Young Professionals Event
Date: 6 September 2018

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ISPE Product Show Committee Meeting
Date: 10 September 2018

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ISPE Board of Directors Meeting
Date: 11 September 2018

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Monthly Education Webinar
Date: 13 September 2018

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ISPE Product Show Committee Meeting
Date: 17 September 2018

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Geographic Outreach (GO) Committee Meeting
Date: 24 September 2018

This is a regularly scheduled GO Committee Meeting. If you have any questions please contact the office at office@ISPEBoston.org or 781-647-4773.

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ISPE Young Professionals Committee Meeting
Date: 25 September 2018

This is a regular meeting of the Young Professionals Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Annual Product Show and Educational Seminars
Date: 26 September 2018

Please note that this is the planned date for the 27th Annual Product Show!

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ISPE Educational Programs Committee Meeting
Date: 3 October 2018

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Board of Directors Meeting
Date: 9 October 2018

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Young Professionals Event
Date: 18 October 2018

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ISPE Fall Social
Date: 25 October 2018

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ISPE Geographic Outreach (GO) Committee Meeting
Date: 29 October 2018

This is a regularly scheduled GO Committee Meeting. If you have any questions please contact the office at office@ISPEBoston.org or 781-647-4773.

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ISPE Young Professionals Committee Meeting
Date: 30 October 2018

This is a regular meeting of the Young Professionals Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 5 November 2018

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Committee Meeting
Date: 7 November 2018

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Monthly Education Program
Date: 8 November 2018

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ISPE Board of Directors Meeting
Date: 13 November 2018

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Geographic Outreach (GO) Committee Meeting
Date: 26 November 2018

This is a regularly scheduled GO Committee Meeting. If you have any questions please contact the office at office@ISPEBoston.org or 781-647-4773.

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ISPE Young Professionals Committee Meeting
Date: 27 November 2018

This is a regular meeting of the Young Professionals Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 3 December 2018

This is a regular meeting for the Product Show Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Educational Programs Committee Meeting
Date: 5 December 2018

This is a regular meeting for the EPC Committee.  If you have any questions, please call the office at 781-647-4773.

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ISPE Monthly Education Program
Date: 6 December 2018

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ISPE Board of Directors Meeting
Date: 11 December 2018

This is a regular meeting for the Board of Directors.  If you have any questions, please call the office at 781-647-4773.

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ISPE Annual Product Show and Educational Seminars
Date: 18 September 2019

Please note that this is the planned date for the 28th Annual Product Show!

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ISPE Annual Product Show and Educational Seminars
Date: 16 September 2020

Please note that this is the planned date for the 29th Annual Product Show!

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ISPE Annual Product Show and Educational Seminars
Date: 15 September 2021

Please note that this is the planned date for the 30th Annual Product Show!

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Page last updated: 29 May 2017