Upcoming Events:

Boston Area Chapter Current Year Events List

Event
ISPE Educational Programs Planning Meeting
Date: 6 January 2016

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: 11 January 2016

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 January 2016

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 New Year's Social
Date: 14 January 2016

Pre-Registration is now closed.  Walk-ins accepted onsite.

Start the New Year off by joining Boston 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.

Thursday, January 14, 2016
6:00 – 9:00pm
Blazing Paddles
85 Lansdowne Street, Boston, MA 02215

Thank you to our Sponsors:
Albireo Energy, LLC (formerly GxP Automation)
A/Z Corporation
Boston Analytical
DPS
JENSEN HUGHES
TRIA

50/50 Raffle benefitting The ALS Foundation

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ISPE Build A Bio
Date: 21 January 2016

PRESENTATION

Peter Cramer and Jeffrey Odum: http://www.ispeboston.org/files/ispe_build_a_bio_-_cramer_and_odum.pdf


EVENT INFORMATION:
Join ISPE Boston Chapter at the UMass Lowell for an eventful Town Hall discussion covering the ins and outs of manufacturing strategies. The program will include a networking reception including appetizers.  As an added bonus, representatives from UMass Lowell are hosting a tour of the Emerging Technologies and Innovation Center. This is an ISPE MEMBER ONLY tour.  Tour participation is limited, so register now!

PROGRAM SUMMARY:
As companies develop both short and long-term manufacturing strategies, operational efficiency and utilization become very critical to optimizing cost-of-goods, manpower planning, and supply chain management.  The approach that companies may take includes new technology and delivery platforms that are “outside the box” from the traditional project models of the past four decades.  During this session we will discuss the key decisions needed to be made in implementing new technologies in a full single use or a hybrid production facility. Our goal is to get feedback from the audience on the needs of the industry and how advances in technology are changing the way new facilities are being designed and built in the future. We will also discuss the implications and risks associated with choosing new technologies versus current industry standards.

TOUR:
The ISPE Boston Area Chapter is also glad to present a rare opportunity to join a tour of UMass Lowell’s Core Research Facilities in the Saab ETIC and Olney Science Center by CRF Staff.

Membership has its privileges!
This tour is open only to ISPE Members and will fill up fast! So register early!

Please check-in before 5:00 and you will be given your tour group schedule.  Tours start at 5:15 PM.|

SPEAKERS: 
Peter Cramer, Vice President of Life Science Facility Design, M+W Group
Peter Cramer, Vice President of Life Science Facility Design for M+W Group, has over 25 years of professional experience in the process architectural field.  Mr. Cramer serves as lead process architect on numerous projects serving the life science industry including vaccine, biotech, API, drug development, packaging and laboratory facilities and pilot plants to name a few.  Past clients have included Pfizer, Wyeth, Baxter, Vertex, Amylin, and Crucell.  Mr. Cramer holds a Master’s of Science degree in Civil Engineering degree from Northeastern University and a Bachelor of Architecture from the University of Miami.  Peter has LEED® AP accreditation and is affiliated with the American Institute of Architects and ISPE. Mr. Cramer is a frequent panelist and speaker for Seminars and Symposiums across the country. 

Jeffrey Odum, CPIP, SME, Director of Operations, Biotech Lead, IPS
Mr. Odum has over 25 years of management experience in the design, construction, and commissioning of facilities in the process, biotechnology, pharmaceutical, and chemical industries.  He is currently the Director of Operations and Biotech Sector Lead at IPS, leading the RTP Office in Morrisville, NC.  A recognized expert in biopharmaceutical manufacturing, Mr. Odum has authored over 60 articles on subjects related to GMP compliance, process improvement, and the design and construction of biopharmaceutical manufacturing facilities.  He is a welcomed speaker at numerous international industry forums and conferences, presenting on topics relating to facility design, bioprocess, project management and GMP compliance.   Mr. Odum, a Certified Pharmaceutical Industry Professional (CPIP), served as the North American Education Advisor to the International Society of Pharmaceutical Engineering (ISPE), is a member of the Biotechnology Community of Practice, a contributing author to numerous industry baseline and reference guides focused on biotechnology manufacturing, process development, project management as well as commissioning and qualification, and is a member of ISPE's technical training faculty.   He has led training efforts in 15 countries, as well as in the US.  He is also a Teaching Fellow in NC State University’s BTEC graduate program in biomanufacturing and a guest Instructor for the North Carolina Community College System BioNetwork Program.

REGISTRATION FEES:

Before 1/14/2016: 
Member $50.00
Young Professional Members $20.00 
Non-Member $95.00
ISPE Student Members: Free to attend

After 1/14/2016: 
Member: $60.00
Young Professional Members $30.00 
Non-Member: $115.00
ISPE Student Members: Free to attend

MEETING MANAGERS:
Mark Braatz, 
FW Webb
John Sheridan, PMA Consultants LLC

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ISPE RE-SHOWING: Build A Bio
Date: 28 January 2016

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

RE-SHOWING OF 1/21 PROGRAM AT


Crowne Plaza Hotel Providence - Warwick

801 Greenwich Street, Warwick, RI 02886

AND AT

WPI Biomanufacturing Education and Training Center at Gateway Park

50 Prescott Street, Worcester, MA 01605

EVENT INFORMATION:
Attend a re-showing at the Crowne Plaza Providence in Warwick, RI or at the WPI BETC at Gateway Park in Worcester, MA.  The programs will both feature a networking reception including refreshments and appetizers.  

PROGRAM SUMMARY:
As companies develop both short and long-term manufacturing strategies, operational efficiency and utilization become very critical to optimizing cost-of-goods, manpower planning, and supply chain management.  The approach that companies may take includes new technology and delivery platforms that are “outside the box” from the traditional project models of the past four decades.  This pre-recorded session will discuss the key decisions needed to be made in implementing new technologies in a full single use or a hybrid production facility. In the live session, our goal was to get feedback from the audience on the needs of the industry and how advances in technology are changing the way new facilities are being designed and built in the future. We will also discuss the implications and risks associated with choosing new technologies versus current industry standards. 

SPEAKERS: 

Peter Cramer, Vice President of Life Science Facility Design, M+W Group
Peter Cramer, Vice President of Life Science Facility Design for M+W Group, has over 25 years of professional experience in the process architectural field.  Mr. Cramer serves as lead process architect on numerous projects serving the life science industry including vaccine, biotech, API, drug development, packaging and laboratory facilities and pilot plants to name a few.  Past clients have included Pfizer, Wyeth, Baxter, Vertex, Amylin, and Crucell.  Mr. Cramer holds a Master’s of Science degree in Civil Engineering degree from Northeastern University and a Bachelor of Architecture from the University of Miami.  Peter has LEED® AP accreditation and is affiliated with the American Institute of Architects and ISPE. Mr. Cramer is a frequent panelist and speaker for Seminars and Symposiums across the country.

Jeffrey Odum, CPIP, SME, Director of Operations, Biotech Lead, IPS
Mr. Odum has over 25 years of management experience in the design, construction, and commissioning of facilities in the process, biotechnology, pharmaceutical, and chemical industries.  He is currently the Director of Operations and Biotech Sector Lead at IPS, leading the RTP Office in Morrisville, NC.  A recognized expert in biopharmaceutical manufacturing, Mr. Odum has authored over 60 articles on subjects related to GMP compliance, process improvement, and the design and construction of biopharmaceutical manufacturing facilities.  He is a welcomed speaker at numerous international industry forums and conferences, presenting on topics relating to facility design, bioprocess, project management and GMP compliance.   Mr. Odum, a Certified Pharmaceutical Industry Professional (CPIP), served as the North American Education Advisor to the International Society of Pharmaceutical Engineering (ISPE), is a member of the Biotechnology Community of Practice, a contributing author to numerous industry baseline and reference guides focused on biotechnology manufacturing, process development, project management as well as commissioning and qualification, and is a member of ISPE's technical training faculty.   He has led training efforts in 15 countries, as well as in the US.  He is also a Teaching Fellow in NC State University’s BTEC graduate program in biomanufacturing and a guest Instructor for the North Carolina Community College System BioNetwork Program.

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

MEETING MANAGERS:
Mark Braatz, FW Webb      
John Sheridan, PMA Consultants LLC

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ISPE Student Career Workshop
Date: 30 January 2016

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

If you will be graduating in 2016-2019, 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 30, 2016

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 Product Show Committee Meeting
Date: 1 February 2016

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 Planning Meeting
Date: 3 February 2016

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 Retro Social
Date: 4 February 2016

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

Come join the ISPE Boston Area Chapter Young Professionals at Roller World for an evening of socializing, roller skating, and food! Come reminisce when roller skating birthday parties were the envy all of your friends and request your favorite 90s songs! Registration includes food and skate rentals and admission to this private event to show off your skating skills!

Thursday, February 4, 2016
7:00 PM - 9:00 PM

Roller World
425r Broadway
Saugus, MA 01906

Registration Fees by 1/27:
Member: $25
Non-Member: $35
Student Member: FREE

Registration Fees after 1/27:
Member: $30
Non-Member: $40
Student Member: FREE

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ISPE Board of Directors Meeting
Date: 9 February 2016

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 Dancing Through Traffic: Facility Expansions in Operating Plants
Date: 18 February 2016

PRESENTATION

Rick Kotosky and John Spohn: http://www.ispeboston.org/files/dancing_through_traffic_-_kotosky_and_spohn.pdf


EVENT INFORMATION: 
Attend the live program at Genzyme in Cambridge, MA, or a simulcast presentation at the Crowne Plaza Providence in Warwick, RI, or a simulcast presentation at the WPI BETC at Gateway Park in Worcester, MA.  The programs at each location will feature a networking reception including refreshments and appetizers.

PROGRAM SUMMARY: 
When companies determine their current GMP facilities cannot support current or future manufacturing requirements, they need to choose whether to renovate, expand, or relocate. Often the decision to retrofit and remediate is the least costly option but most challenging because it must occur in tight quarters with minimal disruption to ongoing processes. Successful execution of these projects require a different approach than the fundamental or classic approach to planning and design. Our speakers will provide direction and strategies that are well-suited to these types of projects.

Specifically, this evening's program will:

*  Methodically presents a different approach to planning and implementation to mitigate product risks and business vulnerability
*  Addresses these key Owner concerns: Limiting production interruptions, developing a high-confidence schedule, proving no adverse effects to process under modification, to product concurrently in-process or to regulatory filings
*  Discusses considerations in all phases of the project lifecycle: Design, Planning, Execution, Return-to-Service
*  Suggests a dramatic shift in the approach to the planning and implementation of retrofit or remediation projects
*  Illustrates with case studies and leaves attendees with actionable information.

WHO SHOULD ATTEND: 

This presentation is intended for industry professionals seeking to gain a better understanding of the challenges of performing facility projects in operating GMP facilities.

SPEAKERS: 
Richard Kotosky, PE, CPIP, Senior Project Manager, Hargrove Life Sciences
Rick is a Senior Project Manager with Hargrove Life Sciences New England Operations with over thirty years of experience. He has held design engineering and project management positions with consulting A/E firms and has also worked directly for manufacturers of biologics, MAbs, vaccines, and medical devices. His operational experience includes roles from Senior Process Engineer to Senior Director of Facilities Operations and he has successfully managed retrofit projects and coordinated full plant maintenance and repair shutdowns in FDA licensed facilities that date back to the early 1900s. Rick is an active member of ISPE and earned his Certified Pharmaceutical Industry Professional™ credential in 2013. He holds a BS in Chemical Engineering from MIT and an MBA from Boston University. 

John Spohn, CPIP, Senior Project Manager, Hargrove Life Sciences
John is a Senior Project Manager with Hargrove Life Sciences New England Operations.   John has provided owner’s representative services and managed mission-critical projects in biotechnology, pharmaceutical and other industries.  He has over thirty years’ experience in the design and implementation of automated processes, systems and equipment.  John is an active member of the ISPE and earned its Certified Pharmaceutical Industry Professional™ credential in 2011.  He serves on the Boston Area Chapter Board of Directors and Educational Program Committee, managing educational presentations and authoring articles and presentations on topics of interest to the Pharmaceutical Engineering community.  John is co-author of the Pharmaceutical Engineering 2013 Article of the Year:  “Automating a Manual Cleaning Program In a Multi-Product Biopharmaceutical Manufacturing Operation”.  He holds a BS in Mechanical Engineering from Rensselaer Polytechnic Institute.


REGISTRATION FEES:

Before 2/11/2016: 
Member $50.00  
Young Professional Members $20.00 
Non-Member $95.00**
ISPE Student Members: FREE
Warwick Location: FREE
WPI BETC Location: FREE 

After 6/11/2015: 
Member: $60.00
Young Professional Memebers $30.00 
Non-Member: $115.00**
ISPE Student Members: FREE
Warwick Location: FREE 
WPI BETC Location: FREE

**Non-members may only attend one program as a non-member**

 

 

MEETING MANAGERS:
Norline Crossdale-Walker, Genzyme
Joseph Kifer, RDK Engineers
Heather Longden, Waters
David Novak, OSDV Engineers, Inc.
Rose Mary Su, Acentech

Thank you to our Sponsor:  

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ISPE Educational Programs Planning Meeting
Date: 2 March 2016

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: 4 March 2016

Pre-Registration is now closed.  Please call the office if you have any questions at 781-647-4773.

Join ISPE for the Chapter's Annual Ski Trip on March 4, 2016 at Waterville Valley.  Space is Limited, so Don't Delay!

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 $310.  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: 

Albireo Energy
A/Z Corporation
Boston Analytical
Commissioning Agents Inc.
Commodore Builders
DPS
JENSEN HUGHES
Reflex Lighting 
RW Sullivan
Sentrol
Superior Controls
TRIA

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ISPE Product Show Committee Meeting
Date: 7 March 2016

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 March 2016

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 Learning Through Doing: The Interplay of Pilot Plant, Product, and Process
Date: 24 March 2016

PANELIST PRESENTATION: http://www.ispeboston.org/files/ispe_pilot_plant_benchmarking_3-24-26.pdf


EVENT INFORMATION: 
Attend the live program at Shire in Lexington, MA.  This program will feature a networking reception including appetizers.  As an added bonus, Shire is hosting a tour of the Shire’s Pilot Plant Facility. This is an ISPE MEMBER ONLY tour.  Tour participation is limited, so register now!  There is also a Young Professional's Pre-Meeting available.

PROGRAM SUMMARY: 
The Pilot Plant plays an instrumental role both in material supply for preclinical and clinical development purposes as well as scale-up of technology and operations.  The ultimate goal is developing a solid process that can be successfully transferred to a commercial manufacturing site.  In the developing age of customizable, specialized biotechnology therapies, how will Pilot Plants adapt to new technology and what niche will the Pilot Plant play in the future product development lifecycle?  

This educational event will include a presentation and panel discussion of Pilot Plant leaders from notable local biotechnology companies.  The current and future role of the pilot plant in the product development lifecycle will be examined.  The group will first present and comment on benchmarking data collected across their companies.  The group will then discuss agility and adaptability of their pilot plants in regards to the current and future pipeline and technologies. 

WHO SHOULD ATTEND: 
This presentation is intended for industry professionals involved in technology transfer, scale-up of manufacturing processes, process development and manufacturing.

TOUR:
The ISPE Boston Area Chapter is also glad to present a rare opportunity to tour Shire’s 200 Shire Way Pilot Plant in Lexington.  Highlights of the tour will include disposable technology and novel purification equipment.

Membership has its privileges!
This tour is open only to ISPE Members and will fill up fast! So register early!
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.

YOUNG PROFESSIONAL’S PRE-MEETING:
Join the YP’s for a pre-meeting session from 4:30PM -5:30PM.

MODERATOR:
Brad Ebel, Manager, Pilot Plant Operations, Shire
Brad Ebel has been active in the biopharmaceutical industry for over 15 years and has been focusing on the disposable industry for over 12 years. He is the Manager of Upstream and Media production in Shire’s Pilot Plant Operation (PPO) Group. While at Shire, he has designed and developed two fully disposable perfusion based cell culture operation facilities; responsible for supporting process development activities up too supplying material for toxicology studies.  Previous to Shire, Brad worked for two different manufacturing companies in Colorado where he was active in process development, MFG and media production groups. While in Colorado he helped developed and commission a stainless steel MFG/PD lab from “dirt” to operation in 6 months. In addition, he was able to develop a MFG process in an ISO 7 (100ft2) laboratoryand later transferred the process to an ISO5-8 (7200+ft2) facility that he helped design, oversaw construction and was an active member of the team responsible for commissioning it into a cGMP facility.  Brad holds his B.S. in Chemistry for Westminster College.

PANELISTS:
Bill Brazier, Senior Manager, Process Development Pilot Plant, Amgen Rhode Island
Bill has 25 years of biotechnology experience in the areas of Manufacturing, Engineering and Process Development. He began his biotech career at Genentech in Manufacturing with roles that included operations, manufacturing technical support, facility and equipment design and start up. After 10 years he transferred to Immunex in Seattle for a role in Process Development responsible for the design, start up and engineering support of the Process Development Facility in Bothell, WA. In 2002 Immunex was acquired by Amgen and he took on roles in global Process Development and Corporate Engineering responsible for developing corporate standards for equipment design. In 2011 he transferred to Amgen Rhode Island for the position of Sr. Manager of the Pilot Plant.

Shaun Grier, Associate Director, Pilot Plant Operations, Shire
Shaun Grier has over 14 years of experience in Process Development, Clinical Manufacturing, and Pilot Plant Operations.   He currently is the Associate Director of downstream processing in Pilot Plant Operations at Shire Pharmaceuticals where he leads a group of downstream specialists responsible for the material production and scale-up of early stage therapeutic candidates.  In addition, his group also supports process development and manufacturing. 

Prior to taking a role in the Pilot Plant, he spent 5 years in Process Development at Shire as a process development engineer where he contributed to the development of several early stage purification processes.  He also has led the technology transfer efforts for several processes to internal and external manufacturing along with regulatory file authoring.   Before joining Shire in 2006, Shaun held positions in clinical manufacturing and Pilot Operations at Wyeth Biopharma.  Shaun holds a B.S in Biology and Chemistry from Fitchburg University and a M.S in Biotechnology Management from the University of Maryland University College.

Christof Schulz, Principal Scientist and Senior Group Leader of Scale-up Laboratory, AbbVie Bioresearch Center
Christof Schulz has over 15 years of experience in the Biotech industry. After obtaining his Ph.D. in Biochemical Engineering, Dr. Schulz worked as a Postdoctoral Scientist in Bioprocess Research and Development at Eli Lilly and Company in Indianapolis, IN. In 2003, Dr. Schulz joined the Abbott Bioresearch Center (now AbbVie Bioresearch Center) in Worcester, MA as a Scientist in Process Sciences. At Abbott and AbbVie, he has been holding positions with increasing responsibility, currently as Principal Scientist and Senior Group Leader of the Process Sciences Scale-up Laboratory.

Dave Sullivan, Director – Bioprocess R&D, Pfizer
David Sullivan is a Director in Pfizer’s Bioprocess R&D Organization responsible for leading the Non-GMP Pilot Plant and development lab support organization.  Pfizer’s Bioprocessing Pilot Plants, located in Andover, MA and Chesterfield, MO, support both early and late stage biologic and vaccine process development.  The primary outputs of the organization include regulatory toxicology and development study drug substance, 100L-1000L process characterization / scale up studies, and implementation of advanced manufacturing processes and process analytical technologies.

David has held a number of diverse roles within the large scale commercial/clinical manufacturing and process development since joining Pfizer in 2004.  Prior to Pfizer, he spent 4 years at Bayer Healthcare as a member of their nucleic acid and infectious disease diagnostics unit.  David received a B.S. from Worcester Polytechnic Institute and an M.S. from Tufts University.

Kelly Wiltberger, Associate Director Manufacturing, Biogen
Kelly currently oversees Biogen’s single-use Flexible Volume Manufacturing (FVM) facility in RTP, NC following over a decade leading the pilot scale teams in various capacities. She collaboratively designed and started up the upstream and downstream RTP pilot scale labs. She managed Pilot Scale Cell Culture Development across three separate sites, successfully integrating the San Diego site into RTP and Cambridge in 2011. She was the RTP Technical Development department site lead, spearheaded the initiative to align equipment and procedures between the RTP and Cambridge labs, and was instrumental in implementing the disposable bioreactor technology now used in FVM. Kelly has played key roles in the development of Advanced Process Control (APC) technology and the N-1 perfusion platform, both of which have recently been successfully implemented into large scale manufacturing processes. Under her leadership, the Pilot Scale group worked extensively on bioreactor characterization and process understanding, collaborating both internally and externally to improve scale-up capabilities and modeling of manufacturing processes.

Kelly holds a BS degree in Chemical Engineering from the University of Rochester as well as an MBA from UNC Chapel Hill and has been a co-author on numerous scientific publications.  


REGISTRATION FEES:

Before 3/17/2016: 
Member $50.00  
Young Professional Members $20.00 
Non-Member $95.00**
ISPE Student Members: FREE
Warwick Location: FREE
WPI BETC Location: FREE 

After 3/17/2016: 
Member: $60.00
Young Professional Memebers $30.00 
Non-Member: $115.00**
ISPE Student Members: FREE
Warwick Location: FREE 
WPI BETC Location: FREE

**Non-members may only attend one program as a non-member**

MEETING MANAGERS:
Stacy Price, Shire
Eric Felz, Shire
Chris Ciampa, Thermo Fisher Scientific

Thank you to our Sponsor:  

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ISPE Student Only Educational Program and Tour of Shire
Date: 30 March 2016

Registration is now closed for this event. Walk-ins will NOT be allowed onsite. If you have any questions please contact our office at 781-647-4773 or office@ISPEBoston.org.

ANNOUNCING A STUDENT ONLY EDUCATIONAL PROGRAM AND PLANT TOUR AT

SHIRE, BUILDING 400, LEXINGTON, MASS

WEDNESDAY, MARCH 30TH, 3:00 – 5:00 PM

See first-hand how an industry leader uses disposable technologies to manufacture specialty gene therapy products.

Learn about Shire’s:

*  Upstream Processing: Disposable and Wave Bioreactors
*  Downstream Processing:  Purification
*  Buffer Preparation
*  Intro to Shire and Disposables Technology Talk
*  Plant Tour

Capacity is limited

Sign up now to secure your spot!

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ISPE RE-SHOWING: Learning Through Doing: The Interplay of Pilot Plant, Product, and Process
Date: 31 March 2016

Pre-Registration is now closed.  Walk-ins accepted on site at all locations.

RE-SHOWING OF 3/24 PROGRAM AT

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

AND AT Tech Collective - Providence
166 Valley Street, Providence, RI 02909

AND AT NEW LOCATION 
Redhook Ale Brewery - Alemaker's Hall
1 Redhook Way, Portsmouth, NH 03801

EVENT INFORMATION:
Join us at the WPI BETC at Gateway Park in Worcester, MA or Tech Collective in Providence, RI or the Redhook Ale Brewery in Portsmouth, NH for a re-showing of the program recorded at Shire, March 24, 2016. A networking reception, including refreshments and appetizers, will be hosted before the presentation at each location. Shaun Grier will be available at WPI BETC in Worcester, MA and Bill Brazier at the Tech Collective in Providence, RI for a live Q&A session after the re-showing of the presentation.


PROGRAM SUMMARY:
The Pilot Plant plays an instrumental role both in material supply for preclinical and clinical development purposes as well as scale-up of technology and operations.  The ultimate goal is developing a solid process that can be successfully transferred to a commercial manufacturing site.  In the developing age of customizable, specialized biotechnology therapies, how will Pilot Plants adapt to new technology and what niche will the Pilot Plant play in the future product development lifecycle? 

This pre-recorded session will include a presentation and panel discussion of Pilot Plant leaders from notable local biotechnology companies.  The current and future role of the pilot plant in the product development lifecycle will be examined.  The group will first present and comment on benchmarking data collected across their companies.  The group will then discuss agility and adaptability of their pilot plants in regards to the current and future pipeline and technologies. 

WHO SHOULD ATTEND: 
This presentation is intended for industry professionals involved in technology transfer, scale-up of manufacturing processes, process development and manufacturing.

MODERATOR:
Brad Ebel, Manager, Pilot Plant Operations, Shire
Brad Ebel has been active in the biopharmaceutical industry for over 15 years and has been focusing on the disposable industry for over 12 years. He is the Manager of Upstream and Media production in Shire’s Pilot Plant Operation (PPO) Group. While at Shire, he has designed and developed two fully disposable perfusion based cell culture operation facilities; responsible for supporting process development activities up too supplying material for toxicology studies.  Previous to Shire, Brad worked for two different manufacturing companies in Colorado where he was active in process development, MFG and media production groups. While in Colorado he helped developed and commission a stainless steel MFG/PD lab from “dirt” to operation in 6 months. In addition, he was able to develop a MFG process in an ISO 7 (100ft2) laboratoryand later transferred the process to an ISO5-8 (7200+ft2) facility that he helped design, oversaw construction and was an active member of the team responsible for commissioning it into a cGMP facility.  Brad holds his B.S. in Chemistry for Westminster College.

PANELISTS:
Bill Brazier, Senior Manager, Process Development Pilot Plant, Amgen Rhode Island
Bill has 25 years of biotechnology experience in the areas of Manufacturing, Engineering and Process Development. He began his biotech career at Genentech in Manufacturing with roles that included operations, manufacturing technical support, facility and equipment design and start up. After 10 years he transferred to Immunex in Seattle for a role in Process Development responsible for the design, start up and engineering support of the Process Development Facility in Bothell, WA. In 2002 Immunex was acquired by Amgen and he took on roles in global Process Development and Corporate Engineering responsible for developing corporate standards for equipment design. In 2011 he transferred to Amgen Rhode Island for the position of Sr. Manager of the Pilot Plant.

Shaun Grier, Associate Director, Pilot Plant Operations, Shire
Shaun Grier has over 14 years of experience in Process Development, Clinical Manufacturing, and Pilot Plant Operations.   He currently is the Associate Director of downstream processing in Pilot Plant Operations at Shire Pharmaceuticals where he leads a group of downstream specialists responsible for the material production and scale-up of early stage therapeutic candidates.  In addition, his group also supports process development and manufacturing. 

Prior to taking a role in the Pilot Plant, he spent 5 years in Process Development at Shire as a process development engineer where he contributed to the development of several early stage purification processes.  He also has led the technology transfer efforts for several processes to internal and external manufacturing along with regulatory file authoring.   Before joining Shire in 2006, Shaun held positions in clinical manufacturing and Pilot Operations at Wyeth Biopharma.  Shaun holds a B.S in Biology and Chemistry from Fitchburg University and a M.S in Biotechnology Management from the University of Maryland University College.

Christof Schulz, Principal Scientist and Senior Group Leader of Scale-up Laboratory, AbbVie Bioresearch Center
Christof Schulz has over 15 years of experience in the Biotech industry. After obtaining his Ph.D. in Biochemical Engineering, Dr. Schulz worked as a Postdoctoral Scientist in Bioprocess Research and Development at Eli Lilly and Company in Indianapolis, IN. In 2003, Dr. Schulz joined the Abbott Bioresearch Center (now AbbVie Bioresearch Center) in Worcester, MA as a Scientist in Process Sciences. At Abbott and AbbVie, he has been holding positions with increasing responsibility, currently as Principal Scientist and Senior Group Leader of the Process Sciences Scale-up Laboratory.

Dave Sullivan, Director – Bioprocess R&D, Pfizer
David Sullivan is a Director in Pfizer’s Bioprocess R&D Organization responsible for leading the Non-GMP Pilot Plant and development lab support organization.  Pfizer’s Bioprocessing Pilot Plants, located in Andover, MA and Chesterfield, MO, support both early and late stage biologic and vaccine process development.  The primary outputs of the organization include regulatory toxicology and development study drug substance, 100L-1000L process characterization / scale up studies, and implementation of advanced manufacturing processes and process analytical technologies.

David has held a number of diverse roles within the large scale commercial/clinical manufacturing and process development since joining Pfizer in 2004.  Prior to Pfizer, he spent 4 years at Bayer Healthcare as a member of their nucleic acid and infectious disease diagnostics unit.  David received a B.S. from Worcester Polytechnic Institute and an M.S. from Tufts University.

Kelly Wiltberger, Associate Director Manufacturing, Biogen
Kelly currently oversees Biogen’s single-use Flexible Volume Manufacturing (FVM) facility in RTP, NC following over a decade leading the pilot scale teams in various capacities. She collaboratively designed and started up the upstream and downstream RTP pilot scale labs. She managed Pilot Scale Cell Culture Development across three separate sites, successfully integrating the San Diego site into RTP and Cambridge in 2011. She was the RTP Technical Development department site lead, spearheaded the initiative to align equipment and procedures between the RTP and Cambridge labs, and was instrumental in implementing the disposable bioreactor technology now used in FVM. Kelly has played key roles in the development of Advanced Process Control (APC) technology and the N-1 perfusion platform, both of which have recently been successfully implemented into large scale manufacturing processes. Under her leadership, the Pilot Scale group worked extensively on bioreactor characterization and process understanding, collaborating both internally and externally to improve scale-up capabilities and modeling of manufacturing processes.

Kelly holds a BS degree in Chemical Engineering from the University of Rochester as well as an MBA from UNC Chapel Hill and has been a co-author on numerous scientific publications.  


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

MEETING MANAGERS:
Stacy Price, Shire
Eric Felz, Shire

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ISPE Sponsored WPI Symposium
Date: 4 April 2016 - 5 April 2016

The WPI Symposium is full.  If you have any qusetions, please contact the office at office@ispeboston.org or 781-647-4773.

ANNOUNCING A SPECIAL OPPORTUNITY FOR STUDENTS

THE WPI BIOMANUFACTURING EDUCATION AND TRAINING CENTER

IS HOSTING A TWO DAY

ADVANCED INDUSTRIAL BIOMANUFACTURING SYMPOSIUM

MONDAY AND TUESDAY, APRIL 4-5, 8AM - 5PM

PROGRAM DETAILS FOR THIS TWO-DAY PROGRAM ARE AVAILABLE HERE

The Boston Area Chapter of ISPE is offering up to 10 stipends for students to attend this two-day program for only $20.00. This is a $130 discount.

Applicants will be accepted on a first come, first served basis. 
You MUST register for this program through the ISPE Boston Area Chapter website to receive this special discount.

Sign up now to secure your spot!

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ISPE Product Show Committee Meeting
Date: 4 April 2016

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 Planning Meeting
Date: 6 April 2016

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: Pizza, Networking, and Bowling
Date: 7 April 2016

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

Back by Popular Demand!
Come join the Young Professional's 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), salad, and dessert. 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!

6:00pm: Pizza and Networking
7:00pm - 9:00pm: Bowling

Registration  by 3/31
ISPE Member: $25
ISPE Student Members: Free
Non-Member: $35

Registration after 3/31
ISPE Member: $30
ISPE Student Member: Free
Non-Member: $40

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ISPE Board of Directors Meeting
Date: 12 April 2016

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 Bruins Game and Networking at Providence
Date: 13 April 2016

Registration is now closed and the event is sold out.  Please call the office if you have any questions at 781-647-4773.

More than just the thrill of the game!!!!
Join us at an evening filled with fun, excitement, food, drinks and networking!  Catch the Providence Bruins play the Springfield Falcons from an amazing location.  The event includes access to the game, cash bar, as well as a buffet (including but not limited to chicken tenders, buffalo wings, hot dogs and more!).   It’s an event worth attending because don't just watch, socialize and network while Bruins play!

Doors open an hour & a half before the game (5:30pm; this time also includes when the restaurant/buffet will open) and the buffet is open for most of the game and ends at the beginning of the 3rd period. 

Wednesday, April 13, 2016
5:30 PM - 9:30 PM

Dunkin' Donuts Center
1 La Salle Square
Providence, RI 02903

Registration Fees by 4/6:
Member: $25
Non-Member: $35
Student Member: FREE

Registration Fees after 4/6:
Member: $30
Non-Member: $40
Student Member: FREE

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ISPE 2016 Student Poster Contest
Date: 20 April 2016

Pre-Registration is now closed.  Please contact the office if you have any questions at 781-647-4773 or office@ispeboston.org.


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

ISPE Boston Area Chapter
ANNUAL STUDENT POSTER CONTEST
on Wednesday, April 20, 2016

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 Atlanta, GA. on September 18-21, 2016. 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)
60 Prescott Street, Worcester, MA

Registration Deadline:
April 13, 2016 at noon

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ISPE Biomanufacturing Science & Technology, Preparing for Tomorrow
Date: 20 April 2016

PRESENTATIONS

Prakash Rai: http://www.ispeboston.org/files/design_and_development_of_next_generation_nanomedicines_-_rai.pdf

Philippe de Vilmorin: http://www.ispeboston.org/files/aducanumab_and_ngm_at_biogen_-_de_vilmorin.pdf

WPI Life Sciences and Bioengineering Center at Gateway Park

60 Prescott Street, Worcester, MA 01605

Or Via Simulcast at:

Biogen, 300 Binney Street, Cambridge, MA 02142
Redhook Ale Brewery, 1 Redhook Way, Portsmouth, NH 03801
The Tech Collective, 166 Valley Street, Providence, RI 02909

EVENT INFORMATION:
Join us for this event and the ISPE student poster contest! Attend the live program or a simulcast presentation at Biogen in Cambridge, MA; Redhook Ale Brewery in Portsmouth, NH; or the Tech Collective in Providence, RI. The programs at all locations will feature a networking reception including appetizers. Cheer on the Student Poster Contestants during the final phase of judging at WPI during the reception hour.

WHO SHOULD ATTEND:
Those working in process development, manufacturing development, equipment designers and facility design & construction companies. Anyone interested in the future of Biomanufacturing and the new manufacturing technologies they should be expecting and planning for.

Science, Technology, and Society, What Will the Next Ten Years Bring?
The Global demand for Biologics and manufacturing capacity is exploding. To meet this demand, medicines need to be affordable and available in mass quantities and the facilities need to be cost effective and flexible.

This program will present information surrounding the direction science is heading, the manufacturing required to deliver new products and the innovative approach to facilities. Our panel consists of educators and industry professionals that will share some of the latest developments in science, manufacturing, and technologies that will shape the future of Biomanufacturing. Join us in a panel discussion with our speakers who will present what they are working on to address these needs.

“Design and Development of Next Generation Nanomedicines” by Prakash Rai
Nanomedicine has the potential to deliver therapeutic agents for enhancing treatment outcome while reducing morbidity. This could dramatically improve treatment responses in several diseases including infectious diseases and especially cancer where the survival statistics have been, so far, dismal. However, progress to date in translating these innovative medicines into commercial success stories is currently limited by the inability to manufacture batches of the nanopharmaceuticals at the required scale and in line with stringent quality control measures required for medical products. Success in developing nanomedicines for clinical use depends on understanding the complex biology, the use of predictive animal models, and the importance of sharing data as key denominators for potential successful translation of nanocarriers from a bench scale into clinical modality for patient care. The global market for nanomedicine, including neurology, cardiovascular, anti-inflammatory, anti-infective, and oncology applications, was valued at $79 billion in 2012 and is expected to reach a value of $178 billion in 2019, predicted to grow 12.3% from 2013 to 2019. It is predicted that nanocarriers will account for 40% of the $136 billion nanotechnology-enabled drug delivery market by 2021. Manufacturing issues in nanomedicine may halt the predicted progress of this field and its imperative that these concerns are tackled in a collaborative way with industry and academia working together to translate nanomedicines

“Aducanumab and Next-Generation Manufacturing at Biogen” by Philippe de Vilmorin
Aducanumab is a monoclonal antibody currently in Phase 3 clinical trials, and it has shown tremendous potential as a disease modifying therapy in Alzheimer’s Disease.  Leveraging the optimism about aducanumab and other promising clinical products, Biogen is building a multi-billion dollar biologics manufacturing facility in Solothurn, Switzerland.  The facility is planned to be the largest ever of its kind, with a total mammalian cell culture capacity that may ultimately exceed 500,000 liters.  This presentation will review the clinical success of aducanumab and introduce the next-generation manufacturing concepts which will enable the Solothurn facility to deliver consistent product quality and unprecedented productivity.

“Avoiding Facility Obsolescence: Immortal Facilities for Increasing Drug Diversity” by Parrish Galliher
As worldwide annual sales of biologics increase toward the 200 bn USD mark, so has the diversity of treatment modalities and drug pipelines increased. Pipeline diversity has grown from recombinant hormones and cytokines to monoclonal antibodies (MAb), MAb-toxin conjugates, Mab antibody fragments, multivalent MAbs, cell-based and rDNA vaccines, precision cell and gene therapies,  therapeutic enzymes, biobetters, biosimilars, biofuels and more. Over the decades, many manufacturing facilities have been unable to accommodate this increasing diversity and have become underutilized, mothballed or obsolete. The presentation will discuss the challenges of increasingly diverse pipelines and process flow architectures and how innovations in manufacturing facility design and operations can maximize facility utilization and help avoid facility obsolescence.

MODERATOR:

Kamal Rashid, PhD, Director and Research Professor, WPI BETC
Kamal has over thirty years of academic experience in both research and biotechnology educational program development plus an additional focus on training at universities including WPI, Utah State University, and Penn State University.

PANELISTS:

Parrish Galliher, Founder and Chief Technology Officer, Xcellerex, a GE Healthcare Life Sciences company
Mr. Galliher earned his BA in Biology at Boston University (1975) and then joined the Biofuels R/D Laboratories of Dynatech R/D Corporation where he built and studied the performance of biomethanation stirred tank and packed bed fermenters to convert coal synthesis gas, kelp seaweed, freshwater algae and municipal solid waste to methane and higher alkanes.  Mr. Galliher then earned his MS degree in Biochemical Engineering at MIT (1981) after which he joined Biogen, Inc. in 1981 where he was responsible for design, commissioning, validation and operation of Biogen’s Cambridge MA. biomanufacturing facilities for both 1500L microbial fermentation and Verax continuous perfusion mammalian cell manufacturing facilities. As Director of Process Engineering, he led the team responsible for the development of the commercial upstream process for Avonex® (beta-Interferon) and the startup, initial validation and commissioning of Biogen’s 2000Lstirred tank Avonex® commercial manufacturing facility, later licensed by the FDA. Mr. Galliher joined Alpha-Beta Technology (ABT) in 1994 as Director of Manufacturing Development and led the technology transfer, startup, validation, and commissioning of ABT’s commercial biopharmaceutical manufacturing plant in Smithfield, RI at which he became Vice President of Operations and General Manager in 1997. Mr. Galliher joined LeukoSite, Inc. in 1999 as Vice President of Biologics Manufacturing and continued in that role after Millennium Pharmaceuticals acquired LeukoSite in 1999. At Millennium, Mr. Galliher led the CMC Team that contributed to FDA and EMA commercial licensure of CAMPATH® monoclonal antibody in 2001-2002.  At Millennium, he created and led the $18M biologics single use manufacturing “Factory of the Future” Program which enabled high speed development of Millennium’s monoclonal antibodies for clinical trials (from clone to new facility to drug in the clinic in 12 months). In December 2002, Mr. Galliher became Founder, President and CEO of Xcellerex, Inc., an advanced single use biomanufacturing technology and services company, at which he led the creation and commercialization of the single use (SU) XDR™ mammalian and microbial bioreactor, XDM™ SU mixing systems and the turnkey SU modular FlexFactory® biomanufacturing platform. As Principal Investigator, Mr. Galliher led Xcellerex's $19M US Gov't DoD DARPA/DTRA prime contract for the "Accelerated Manufacture of Pharmaceuticals Program" (AMP), awarded in 2007 and continued through Phase 2 and successful Swine flu Live Fire Test in 2010. In 2012 GE Healthcare acquired Xcellerex Inc. and Mr. Galliher took on the new role of Chief Technology Officer, Upstream for GEHC. In 2012 Mr. Galliher was awarded Bioprocess International’s 2012 “Thought Leader of the Decade, Upstream”. Mr. Galliher is committed to the potential of biotechnology to transform human health, and is a co-inventor of numerous patents in the field of advanced, high efficiency biomanufacturing technologies.

Philippe de Vilmorin, Senior Engineer, Biogen
Philippe de Vilmorin is a Senior Engineer at Biogen and Technical Development Lead for the Next Generation Manufacturing project.  During more than 13 years at Biogen, he has contributed to development of manufacturing processes and control strategies for biologics including Tysabri, Alprolix, Eloctate, and Plegridy.  Recently he has been leading development teams for early-stage biologics, applying innovative approaches to minimize the time between discovery and clinical studies.  His latest focus is on the design of Biogen’s next-generation manufacturing facility for mass production of future commercial products.  Phil has a Bachelor of Science degree in Chemical Engineering from MIT.

Prakash Rai, PhD, Assistant Professor, UMass Lowell
Prakash Rai, Ph.D., joined the Department of Chemical Engineering at UMass Lowell in 2012 as a tenure-track Assistant Professor. Prior to this he was an Instructor at the Center for Engineering in Medicine at Massachusetts General Hospital (MGH) and Harvard Medical School. Dr. Rai is currently working on developing translational nanotechnology-based platforms for imaging, prevention and treatment of breast cancer. His research involves designing, synthesizing, characterizing, and evaluating the efficacy of these nano-platforms in cell culture, as well as animal models of the disease. Dr. Rai has several first author publications in journals including Nature Biotechnology, Proceedings of the National Academy of Sciences, Angewandte Chemie, and Cancer Research. In 2010, Dr. Rai was chosen to receive the "Scholar in Training" award by the American Association of Cancer Research. Dr. Rai received his Bachelor's degree in Chemical Engineering from the University of Mumbai, India in 2003 and his Ph.D. in Chemical and Biological Engineering from Rensselaer Polytechnic Institute in 2007. Recently he received a grant award from the National Cancer institute to carry out research in the area of cancer nanomedicine

REGISTRATION FEES:
Before 4/13/2016: 
Member $50.00  
Young Professional Members $20.00 
Non-Member $95.00**
ISPE Student Members: FREE
Cambridge Location: FREE
Providence Location: FREE 
Portsmouth Location: FREE 

After 4/13/2016: 
Member: $60.00
Young Professional Memebers $30.00 
Non-Member: $115.00**
ISPE Student Members: FREE
Cambridge Location: FREE
Providence Location: FREE 
Portsmouth Location: FREE 

**Non-members may only attend one program as a non-member**

 

MEETING MANAGERS:
Cheryl Huie, Axiom Collaborative
Joe Kifer, RDK Engineers
Dan Mardirosian, WPI BETC
Zoey Shen, WPI

 

Thank you to our Sponsor:  

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ISPE Young Professionals Committee Meeting
Date: 26 April 2016

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: 2 May 2016

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 Planning Meeting
Date: 4 May 2016

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: 9 May 2016

The Spring Golf Tournament is sold out.  Please contact the office at 781-647-4773 if you have any questions.

SCHEDULE:
11:30 AM - 12:45 PM Registration and Buffet Lunch 
1:00 PM -Shotgun Start – Scramble Format 
5:30 PM - Reception/Cocktails/Buffet Dinner

COST:
$700 Foursome/$175 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: 10 May 2016

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 Single Use: From Toddler to Adolescent
Date: 19 May 2016

The tour portion of the program is sold out. If you have any questions, please contact the office at 781-647-4773 or office@ispeboston.org.

Pre-Registration for the seminar will close May 17th at noon.

EVENT INFORMATION: 
Attend the live program at Shire in Lexington, MA.  This program will feature a networking reception including appetizers.  As an added bonus, Shire is hosting a tour of Shire’s Pilot Plant Facility with an emphasis on single use implementation. This is an ISPE MEMBER ONLY tour.  Tour participation is limited, so register now!  

PROGRAM SUMMARY: 
Single use was an emerging, breakthrough technology a decade ago.  After justifying capital savings and operational efficiencies, Biotech has adopted single use as a mainstream manufacturing approach. Our industry has learned a great deal about additional challenges that present themselves when implementing single use in various configurations and in combination with more traditional manufacturing approaches.  Come to find out first-hand the experiences of two industry experts who have witnessed the progression of single-use from toddlerhood to adolescence, and who have uncovered previously hidden considerations. Our speakers will enrich their accounts with actual examples from a pilot plant.

WHO SHOULD ATTEND: 
Vendors, service providers, integrators and users of single use technology will all benefit from this event.

TOUR:
The ISPE Boston Area Chapter is also glad to present a rare opportunity to tour Shire’s 200 Shire Way Pilot Plant in Lexington.  Highlights of the tour will include single-use technology and novel purification equipment.

Membership has its privileges!
This tour is open only to ISPE Members and will fill up fast! So register early!
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.

PART 1: Uncovering Hidden Costs Behind Implementing Effective Single Use Technology
As Biotech and Pharmaceutical companies continue to increase their dependence on Single Use Technologies (SUT), effective integration of QRM and SUT is paramount to ensuring both project and operational success. There are several key elements to ensure an effective integration into current engineering, materials management/supply chain, manufacturing operations and quality assurance business systems. Project success also depends on providing the framework for a life-cycle based approach toward SUT implementation. These key programmatic elements will be outlined and through the combination of direct project/practical experience and programmatic development, Mark McElligott will demonstrate robust, effective and sustainable methodologies for reducing risks associated with SUT integration.

SPEAKER:
Mark McElligott, Partner/Principal Process Engineer, Process Design Solutions and PDS Sandbox
Mark McElligott is the Founder of PDS Sandbox, as well as, Partner and Principal SU Engineer with PDS Consulting which are companies providing Single Use technical engineering, QbD/QRM, process/product development/design solutions for Single Use Technology (SUT) end users and suppliers alike. Mr. McElligott has 18+ years of experience in the biopharmaceutical, medical device and pharmaceutical industries and his consulting expertise is focused on SUT engineering for cGMP Manufacturing Operations, SUT Implementation feasibility assessments, Leachables and Extractables Program Development, Material Science Evaluations, Process Optimization/Debottlenecking, QbD/QRM and Product/Process Development. Mark has developed and successfully implemented life-cycle based SUT programs across the globe by working with end-users and suppliers to establish appropriate and relevant requirements supporting patient safety and product quality.


PART 2: Adaptation of Single-Use Technology in Pilot Plant Operations
Development laboratories utilizing disposable/single-use technology are beneficial because of their lower initial capital expense, faster turnaround times, flexibility to run multiple products in the same facility and reduction of product cross-contamination risk. However, single-use technology also comes with multiple challenges.  Shire’s development laboratory predominantly runs perfusion-based cell culture for multiple weeks using two different types of cell retention technologies: centrifugation and Alternating Tangential Flow (ATF) filtration.  This presentation will focus on the challenges encountered transferring these two sciences from the small-scale development laboratory to the single-use pilot laboratory.  By the end of the presentation you will have a better understanding of the following:
       - How the adoption of single-use systems significantly alters the development model.
       - The design and development required to integrate single-use systems into your facility
       - How to partner with your selected single-use vendor(s) to achieve success 

SPEAKER:
Brad Ebel, Manager, LSDL, Shire Pharmaceuticals
Brad Ebel has been active in the biopharmaceutical industry for over 15 years and has been focusing on the disposable industry for over 12 years. He is the Manager of Upstream and Media production in Shire’s Pilot Plant Operation (PPO) Group. While at Shire, he has designed and developed two fully disposable perfusion based cell culture operation facilities; responsible for supporting process development activities up too supplying material for toxicology studies.  Previous to Shire, Brad worked for two different manufacturing companies in Colorado where he was active in process development, manufacturing and media production groups. While in Colorado he helped developed and commission a stainless steel MFG/PD lab from “dirt” to operation in 6 months. In addition, he developed a manufacturing process in an ISO 7 (100ft^2) laboratory and later transferred the processs to an ISO5-8 (7200+ft^2) cGMP facility that he helped design, provide construction oversight, and commission.  Brad holds his B.S. in Chemistry for Westminster College.

REGISTRATION FEES:
Before 5/12/2016: 
Member $50.00  
Young Professional Members $20.00 
Non-Member $95.00**
ISPE Student Members: FREE

After 5/12/2016: 
Member: $60.00
Young Professional Memebers $30.00 
Non-Member: $115.00**
ISPE Student Members: FREE

**Non-members may only attend one program as a non-member**

MEETING MANAGERS:
Joyce Chiu
Chris Opolski

Thank you to our Sponsor:  

 

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ISPE Brainstorming Session For 2017 Educational Programming
Date: 25 May 2016

We Need Your Help!
Join our annual brainstorming get-together for 2017-2018 educational programs

Biogen
225 Binney Street, Cambridge, MA

The Educational Program Committee of the ISPE Boston Area Chapter is sponsoring a free fun get-together with door prizes to brainstorm topics for the 2017-2018 season. If you have ideas for educational programs, speakers, or locations, please join us to share your thoughts. The session will begin with a networking reception and light dinner, and continue with a forum where attendees will offer their ideas and suggestions.  All ideas will be voted on by the entire Boston area chapter membership via electronic survey. Results off the survey will be presented in July at which time you may volunteer to be a program manager or assist in another manner for a specific event. Please consider volunteering for the Educational Programs Committee to make these programs come to life!

Attendance is free (we want your ideas!), so please come and help us plan and brainstorm! All you have to do is RSVP via the website. If you have ideas but are unable to attend, please send your ideas to the office at office@ispeboston.org.

SCHEDULE:

5:30 - 6:30 pm Networking Reception with light dinner served
6:30 - 8:30 pm Brainstorming Session

COST: Free

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ISPE RE-SHOWING: Single Use: From Toddler to Adolescent
Date: 26 May 2016

RE-SHOWING OF 5/19 PROGRAM AT

WPI Biomanufacturing Education and Training Center at Gateway Park

50 Prescott Street, Worcester, MA 01605

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

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

EVENT INFORMATION: 
Join us at the WPI BETC at Gateway Park in Worcester, MA; Doherty’s Ale House in Warwick, RI; or the Redhook Ale Brewery in Portsmouth, NH for a re-showing of the program recorded at Shire, May 19, 2016. A networking reception, including refreshments and appetizers, will be hosted before the presentation at each location. 

PROGRAM SUMMARY: 
Single use was an emerging, breakthrough technology a decade ago. After justifying capital savings and operational efficiencies, Biotech has adopted single use as a mainstream manufacturing approach. Our industry has learned a great deal about additional challenges that present themselves when implementing single use in various configurations and in combination with more traditional manufacturing approaches. This pre-recorded session will include a presentation regarding first-hand the experiences of two industry experts who have witnessed the progression of single-use from toddlerhood to adolescence, and who have uncovered previously hidden considerations. Our speakers will enrich their accounts with actual examples from a pilot plant.

WHO SHOULD ATTEND: 
Vendors, service providers, integrators and users of single use technology will all benefit from this event.

PART 1: Uncovering Hidden Costs Behind Implementing Effective Single Use Technology
As Biotech and Pharmaceutical companies continue to increase their dependence on Single Use Technologies (SUT), effective integration of QRM and SUT is paramount to ensuring both project and operational success. There are several key elements to ensure an effective integration into current engineering, materials management/supply chain, manufacturing operations and quality assurance business systems. Project success also depends on providing the framework for a life-cycle based approach toward SUT implementation. These key programmatic elements will be outlined and through the combination of direct project/practical experience and programmatic development, Mark McElligott will demonstrate robust, effective and sustainable methodologies for reducing risks associated with SUT integration.

SPEAKER:
Mark McElligott, Partner/Principal Process Engineer, Process Design Solutions and PDS Sandbox
Mark McElligott is the Founder of PDS Sandbox, as well as, Partner and Principal SU Engineer with PDS Consulting which are companies providing Single Use technical engineering, QbD/QRM, process/product development/design solutions for Single Use Technology (SUT) end users and suppliers alike. Mr. McElligott has 18+ years of experience in the biopharmaceutical, medical device and pharmaceutical industries and his consulting expertise is focused on SUT engineering for cGMP Manufacturing Operations, SUT Implementation feasibility assessments, Leachables and Extractables Program Development, Material Science Evaluations, Process Optimization/Debottlenecking, QbD/QRM and Product/Process Development. Mark has developed and successfully implemented life-cycle based SUT programs across the globe by working with end-users and suppliers to establish appropriate and relevant requirements supporting patient safety and product quality.


PART 2: Adaptation of Single-Use Technology in Pilot Plant Operations
Development laboratories utilizing disposable/single-use technology are beneficial because of their lower initial capital expense, faster turnaround times, flexibility to run multiple products in the same facility and reduction of product cross-contamination risk. However, single-use technology also comes with multiple challenges.  Shire’s development laboratory predominantly runs perfusion-based cell culture for multiple weeks using two different types of cell retention technologies: centrifugation and Alternating Tangential Flow (ATF) filtration.  This presentation will focus on the challenges encountered transferring these two sciences from the small-scale development laboratory to the single-use pilot laboratory.  By the end of the presentation you will have a better understanding of the following:
       - How the adoption of single-use systems significantly alters the development model.
       - The design and development required to integrate single-use systems into your facility
       - How to partner with your selected single-use vendor(s) to achieve success 

SPEAKER:
Brad Ebel, Manager, LSDL, Shire Pharmaceuticals
Brad Ebel has been active in the biopharmaceutical industry for over 15 years and has been focusing on the disposable industry for over 12 years. He is the Manager of Upstream and Media production in Shire’s Pilot Plant Operation (PPO) Group. While at Shire, he has designed and developed two fully disposable perfusion based cell culture operation facilities; responsible for supporting process development activities up too supplying material for toxicology studies.  Previous to Shire, Brad worked for two different manufacturing companies in Colorado where he was active in process development, manufacturing and media production groups. While in Colorado he helped developed and commission a stainless steel MFG/PD lab from “dirt” to operation in 6 months. In addition, he developed a manufacturing process in an ISO 7 (100ft^2) laboratory and later transferred the processs to an ISO5-8 (7200+ft^2) cGMP facility that he helped design, provide construction oversight, and commission.  Brad holds his B.S. in Chemistry for Westminster College.

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

MEETING MANAGERS:
Joyce Chiu
Chris Opolski

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ISPE Young Professionals Committee Meeting
Date: 31 May 2016

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 Membership Drive
Date: 1 June 2016

Join us at Genzyme Framingham for a Membership Drive!

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ISPE Educational Programs Planning Meeting
Date: 1 June 2016

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 June 2016

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: 14 June 2016

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 Data Integrity: Part 11 is the Least of Your Problems
Date: 16 June 2016

EVENT INFORMATION: 
You are invited to attend a live program on Data Integrity with a focus on the recent FDA draft guidance for "Data Integrity and Compliance with CGMP." The event will be held at the Crowne Plaza in Warwick, RI, and simulcast at the WPI LSBC in Worcester, MA; the Redhook Ale Brewery in Portsmouth, NH; and the Tufts Gordon Institute in Medford, MA.  Each venue will feature a networking reception with refreshments and a live Q&A after the presentation. Register now to stay up-to-date on the new FDA guidance!

PROGRAM SUMMARY: 
"Data Integrity" is more than just a buzzword.  With the recent release of the FDA’s draft guidance for “Data Integrity and Compliance With CGMP” this April, it is apparent now more than ever that the pharmaceutical industry still has room to grow when it comes to understanding the serious risks associated with the generation, handling, and archival of GMP data.  The continued issuance of warning letters, consent decrees, and other regulatory action around data integrity has led some organizations to rethink control of their data.  In this program, we will get two different perspectives on the issue: one from an industry expert equipment vendor who leads the industry in Part 11 compliance with over 25 years of experience; the other from a consultant with more than 30 years of experience working to improve GxP compliance in the pharmaceutical, biotechnology, and medical device industries.  To conclude the program, our speakers will open up the discussion to the audience for questions and answers.

WHO SHOULD ATTEND: 
QA/QC, IT, Validation, Regulatory, Engineers, Auditors, Compliance officers, Lab managers, automation engineers, laboratory and computer systems validation engineers, and any individual responsible for generating or handling data.

SPEAKERS:
Heather Longden, Senior Marketing Manager, Waters
After a number of years in training, supporting and selling Waters Software, Heather's current role is as a specialist in compliance with e-record regulations, acting as a resource to the global informatics community at Waters and the users of all Waters informatics products. This involves helping design the compliance into Waters’ informatics products and services, attending and presenting at specialist conferences, keeping up to data on the latest interpretations and amendments to the regulations, and disseminating this information to the Waters field and corporate organizations.

Heather also manages the global Empower Product Management team. This team has significant responsibility for supporting our global customer base and managing the backlog of feature enhancements and defect fixes requested by our customers for inclusion in future releases.

Robert Wherry, Principal Consultant, PAREXEL International
Principal Consultant, Strategic Compliance Services at PAREXEL. Certified ISPE CPIP. Previously with Sunovion, Sepracor, and Rhône-Poulenc Rorer. Thirty-plus years’ experience in the pharmaceutical, biotechnology, and medical device industries, with expertise in Quality Systems, GxP regulations, ERES/CSV and Part 11 compliance, Regulatory Operations and eCTD, aseptic processing, process validation, and QSR production and process control. MSc in Pharmaceutical Quality from University of Strathclyde and MS in Regulatory Affairs from Northeastern University. BS in Chemical Engineering from Lehigh University.

REGISTRATION FEES:
Before 6/9/2016: 
Member $50.00  
Young Professional Members $20.00 
Non-Member $95.00**
ISPE Student Members: FREE
Worcester Location: FREE
Portsmouth Location: FREE
Medford Location: FREE  

After 6/9/2016: 
Member: $60.00
Young Professional Memebers $30.00 
Non-Member: $115.00**
ISPE Student Members: FREE
Worcester Location: FREE
Portsmouth Location: FREE
Medford Location: FREE   

**Non-members may only attend one program as a non-member**

MEETING MANAGERS:
Jack Campion, The Hart Companies
James Hughes, Shire
Brijesh Patel, Shire

Thank you to our Sponsor:  

 

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ISPE Luau Summer Social
Date: 23 June 2016

Join the ISPE Boston Area Chapter for a Tropical Luau Beach Party to celebrate the start of Summer and Volunteer Appreciation Night!

Thursday, June 23, 2016
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 (www.servings.org)
Live Band
BBQ Feast
1 Drink ticket with admission
Cash bar

Abundant street parking can be found along Quincy Shore Drive

Thank you our Summer Social Sponsors!
Albireo Energy
Boston Analytical
DPS
Hereva Consultants
Jensen Hughes
LJ Star
New England Laboratories
Northeast Engineering
RW Sullivan
SPEC Process Engineering
TRIA

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ISPE Young Professionals Committee Meeting
Date: 28 June 2016

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: 11 July 2016

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 July 2016

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 2017 Season Planning Meeting
Date: 20 July 2016

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ISPE Young Professionals Red Sox Social
Date: 21 July 2016

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ISPE Young Professionals Committee Meeting
Date: 26 July 2016

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: 1 August 2016

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 Planning Meeting
Date: 3 August 2016

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 Summer Golf Tournament
Date: 8 August 2016

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This year the Social Committee is bringing us to a great location for a golf tournament - Lake Winnipesaukee Golf Club. Lake Winnipesaukee Golf Club is a private, 18-hole Clive Clark championship course that offers the golf experience of a lifetime - again and again. A stunning 700 mountain acres shelter almost 7,000 yards of magic. From magnificent bent grass tees and fairways to elegant greens, an exquisite experience nurtured by state-of-the-art technologies and the game's premier staff professionals. 

Click here for a video tour of the club: http://www.lwgcnh.com/The-Club/Video-Tours.aspx

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ISPE Product Show Committee Meeting
Date: 15 August 2016

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: 16 August 2016

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: 17 August 2016

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: 29 August 2016

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: 30 August 2016

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: 7 September 2016

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: 8 September 2016

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ISPE Product Show Committee Meeting
Date: 12 September 2016

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: 13 September 2016

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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Accidental Project Manager
Date: 15 September 2016

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ISPE Annual Meeting
Date: 18 September 2016 - 21 September 2016

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ISPE RE-SHOWING: Accidental Project Manager
Date: 22 September 2016

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ISPE Product Show Committee Meeting
Date: 26 September 2016

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: 27 September 2016

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: 5 October 2016

Please note that this is the planned date for the 25th Annual Product Show!

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ISPE Board of Directors Meeting
Date: 11 October 2016

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: 12 October 2016

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 Classroom Training
Date: 17 October 2016 - 20 October 2016

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ISPE Young Professionals Committee Meeting
Date: 25 October 2016

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
Date: 27 October 2016

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ISPE Educational Programs Planning Meeting
Date: 2 November 2016

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: 8 November 2016

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 QBD
Date: 10 November 2016

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ISPE RE-SHOWING: QBD
Date: 17 November 2016

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ISPE Young Professionals Committee Meeting
Date: 29 November 2016

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 Young Professionals Social
Date: 1 December 2016

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ISPE Educational Programs Planning Meeting
Date: 7 December 2016

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 December 2016

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 Joint with ISA
Date: 15 December 2016

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ISPE RE-SHOWING: Joint with ISA
Date: 22 December 2016

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ISPE Young Professionals Committee Meeting
Date: 27 December 2016

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 CIP & SIP
Date: 19 January 2017

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ISPE RE-SHOWING: CIP & SIP
Date: 26 January 2017

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ISPE Water, Water, Everywhere
Date: 16 February 2017

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ISPE RE-SHOWING: Water
Date: 23 February 2017

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ISPE C&Q Baseline Guide Update
Date: 16 March 2017

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ISPE RE-SHOWING: C&Q Baseline Guide
Date: 23 March 2017

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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!

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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 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: 23 November 2015