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Boston Area Chapter Current Year Events List

Event
ISPE Product Show Committee Meeting
Date: 5 January 2015

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: 7 January 2015

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 January 2015

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 The Future is NOW for Continuous Manufacturing
Date: 15 January 2015

http://www.ispeboston.org/files/cattaneo_presentation.pdf 

http://www.ispeboston.org/files/mihlbachler_presentation_for_printing.pdf  

PROGRAM SUMMARY:

If your initial reaction is:  Impossible!  Can’t be done!  Not with MY process!  You may be surprised to learn that continuous manufacturing is much closer than you think.  As our industry evolves and matures, we continue investigating ways to produce biopharmaceutical products more efficiently. Come and learn from three cutting edge speakers working on different areas of this same complex issue as the Chapter presents a “future trends” program to kick off the 2015 educational program year!

Following up on the Lean and Six Sigma concepts covered during the Chapter’s December educational program, continuous manufacturing can offer process efficiencies that appeared unimaginable just a short time ago.  This program focuses on the science and technology behind different strategies sucessfully used to continuously manufacture products.

Salvatore Mascia will speak about how integrated continuous manufacturing (ICM) has been implemented at the first ever ICM pilot plant, developed by Novartis and MIT’s Center for Continuous Manufacturing to convert raw materials into finished products on a continuous basis. 

Maurizio Cattaneo will speak about how to leverage the science behind the design of experiments (DOE) and quality by design (QbD) concepts to create efficiencies in monoclonal antibody production which have increased yields ten-fold by using continuous manufacturing techniques. 

Kathleen Mihlbachler will speak about the use of multi-column continuous (MCC) chromatography for the effective separation of chiral (mirror image) compounds on a continuous basis and how this approach can be integrated into a more complex manufacturing strategy. 

SPEAKERS:

Salvatore Mascia, Ph.D., Founder and CEO, CONTINUUS Pharmaceuticals
Salvatore Mascia is the Founder & CEO of CONTINUUS Pharmaceuticals. He was the former Strategic Project Manager at the Novartis-MIT Center for Continuous Manufacturing, where he led the integration of the first end-to-end continuous manufacturing process for pharmaceuticals. At the end of the project, he was presented with the “Leadership Award” that recognized his leadership role at the Center. Dr. Mascia gained experience in strategic management and fund raising in addition to leadership skills via various roles of responsibility within the entrepreneurial ecosystem.  Among those, he co-founded “Professional Italians in Boston” in 2009, and served as President of the “Cambridge University Technology and Enterprise Club” in 2006/07.  He also ran a pharmacy business for 2 years.  Dr. Mascia completed a post-doc at MIT in Chemical Engineering and holds a PhD in Chemical Engineering from the University of Cambridge, UK and a BS and MS in Pharmacy (summa cum laude) from University of Perugia, Italy.

Maurizio Cattaneo, Ph.D., CEO, BioVolutions, Inc.
Dr. Cattaneo obtained his Bachelor of Applied Sciences Degree in Chemical Engineering from the University of Toronto and his MS and Ph.D. from McGill University. Dr. Cattaneo was a Research Officer at the National Research Council of Canada where he specialized in the development of human monoclonal antibodies by phage display. Most recently, Dr. Cattaneo spent one year at MIT developing single use systems for manufacturing monoclonal antibodies by cell culture. Dr. Cattaneo holds 6 patents in the field of bioprocess and biotechnology. Dr. Cattaneo is now CEO of BioVolutions, Inc. a local CMO offering diagnostic and therapeutic monoclonal antibodies made by Continuous Manufacturing. Dr. Cattaneo attained his Certified Pharmaceutical Industry Professional (CPIP) credential in 2013.

Kathleen Mihlbachler, Ph.D., Director of Global Separation Development, LEWA Process Technologies
Dr. Mihlbachler has worked in the field of process chromatography for more than 15 years. Currently, she is the Global Director of Separations Development at LEWA Process Technologies. She is responsible for the development of separation technologies for synthetic and biological molecules, in particular for continuous processing. Prior to this appointment, Dr. Mihlbachler worked as an external consultant for LEWA-NIKKISO since 2012 where she supported the technical transfer of process chromatographic technology and consulted in customer projects. Previously, Dr. Mihlbachler was involved as a Sr. Researcher at BMS, Eli Lilly and Pfizer in the development, scale-up and manufacturing of purification/separation processes for chiral and non-chiral compounds, peptides and proteins, in particular to implement continuous processes. From 2011 to 2013, Dr. Mihlbachler taught undergraduate courses for chemical and biomedical students at New Jersey Institute of Technology.

REGISTRATION FEES:

Before 1/8/2015: 

Member $50.00  
Young Professional Members $20.00 
Non-Member $95.00**
ISPE Student Members: Free to attend
Warwick Location: FREE 

After 1/8/2015: 

Member: $60.00
Young Professional Memebers $30.00 
Non-Member: $115.00**
ISPE Student Members: Free to attend
Warwick Location: FREE 

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

 

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ISPE New Year's Social
Date: 22 January 2015

THIS PROGRAM IS SOLD OUT! Walk-ins will NOT be accepted onsite. Call the office with questions 781-647-4773.

ISPE Boston Area Chapter and I2SL New England Joint Event:

New Year's NETWORKING Social

Thursday, January 22, 2015
Flat Top Johnny’s 1 Kendall Square Cambridge, MA, 02139
6:00 - 9:00 PM

Come join ISPE Boston Area Chapter and I2SL New England and celebrate the New Year with Friends and Colleagues! Light fare and cash bar will be provided.

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 the industry. Add your personal interests to your badge to facilitate more networking. If you do not indicate an interest, one will be assigned to you!

Registration Fee:

$10 for Members of ISPE or I2SL
$20 for Non Members

 

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ISPE Young Professionals Committee Meeting
Date: 28 January 2015

If you have any questions regarding this committee meeting, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 2 February 2015

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 February 2015

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 Career Workshop
Date: 7 February 2015

If you will be graduating in 2015-2018, 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, February 7, 2015

10:00 AM – 5:00 PM

Doors open at 9:30AM

 

WHERE

Northeastern University

Alumni Center

Pavilion Room (6th fl)

716 Columbus Ave

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 Board of Directors Meeting
Date: 10 February 2015

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 Myth Busting Biopharm Facility Designs through Leading Edge Concepts
Date: 19 February 2015

EVENT INFORMATION:
Attend the live program at Genzyme Center in Cambridge, MA or a simulcast presentation at the Crowne Plaza Providence in Warwick, RI or at the WPI BETC at Gateway Park in Worcester, MA. The programs at all three locations will include a networking reception including appetizers.

PROGRAM SUMMARY:
The emerging trends in our highly regulated industry require a unique approach and broad experience base to optimize facility designs and implement process improvements in a validated environment. This event brings three industry experts together to provide diverse perspectives on trends, techniques and strategies to implement world-class facility operations. There is a revolution within the Biotech and Pharmaceutical Industries where sharing best practices will enhance standards to address emerging issues such as process complexity, adoption of new technologies, and contamination risks. This collaborative event brings these unique perspectives together, covering:

Facilities Optimization Design Perspectives
The first presentation will illustrate areas where facility design is impacted by the number of products in the pipeline, operational ease, operating costs, and the impact of yield changes. Facility Design Optimization is often overlooked or not fully addressed when developing a facility for a specific process. Designing an optimal facility  requires the input from all stakeholders and incorporating critical input ensuring compliance and consideration for process, risk(s), compliance and operations into account.

Biotech Facility Best Practices
The second presentation focuses on Biotech manufacturing facilities with complex and technical cleaning requirements. Real World examples  of FDA requirements, Quality Practices and Consultant Advice in the Biopharm industry that have contributed to high costs, poor facility hygiene and increased operator and building hazards. There is Best Practice that keeps patients and operators safe and complies with cGMPs will be shared. These Best Practices will be coveredin this presentation, where common myths will be busted.

Facility Optimization Considerations
The closing presentation will provide broad range of consideration exploring Facilities Optimization from the Facilities Management and Facilities Engineering viewpoint. We hear a lot about design, construction and optimization of layout, utilities, capacity and processing areas of new facilities. This presentation looks at a wide range of optimization considerations, including; maintenance programs, calibration and maintenance intervals, capital budgets and resources, facility and utility robustness, process optimization, and evaluations techniques for these categories. Considerations to maximize capital budgets and thoughts on optimal facilities team composition to successfully operate these complex facilities – what? This sentence is missing a closing.

Please join these industry experts and our distinguished panel to learn more about these topics and participate in a Q&A session at this ISPE Boston educational event.

SPEAKERS:

William Jacobsen, Chief Technology Officer, Dovetail Integrated Systems
Mr. Jacobsen has responsibility for leading initiatives focused on optimization and standardization of manufacturing operations. Mr. Jacobsen has extensive experience in biotechnology process development, manufacturing and operations and is considered a subject matter expert for single use systems. He has played key roles in the design, start-up, validation and operation of cell culture facilities at numerous Boston based Biologics companies. These facilities ranged from pilot to full-scale manufacturing. As a consultant, Mr. Jacobsen led the $20M facility expansion at a newly formed CMO based on single use systems. Mr. Jacobsen received his BS in in-vitro cell Biology from the State University of New York at Plattsburgh.

Doyle Johnson, Life Sciences Industry Leader, Hargrove Life Sciences, LLC
Doyle has over thirty years of domestic and international experience in in the chemical, pharmaceutical and biotech industries. His expertise and knowledge includes hands-on operations and project management, technical and business management, process engineering, customer relations and regulatory requirements. Experiences include managing projects up to $120MM total installed cost. Doyle has experience from the owner’s side (Genzyme, MassBiologics) as well as the contractor’s side (CDI/Herzog-Hart, and Hargrove Life Sciences, LLC). As testament to his leadership and expertise, Doyle served on the Board of Directors for the International Society for  Pharmaceutical Engineering (ISPE) and the Engineering and Construction Contracting Association (ECC). Doyle has particular skills in Site Remediation, having been part of the Site Leadership Team at Genzyme during their FDA Consent Decree period. He has managed the operation of two large facilities in Boston – the MassBiologics Laboratories and Genzyme Framingham.

Mike St. Louis,Vice President of Operations, CPS Group
Mike St.. Louis has 22 years of experience in construction and operation of high technology facilities serving the Semiconductor, Pharmaceutical and Biotechnology industry. He previously worked at Olympus Biotech (formerly Stryker) and prior to that Project Manager for Kinetic Systems, Inc. In that time his experience  included roles as a Project Engineer, Project Manager, Manager of Capital Projects, Facilities Engineering Manager and Director of Plant Services, participating in the design, construction, commissioning, qualification and operation of process utility systems. Mr. St. Louis holds a BS degree in Construction Management from Boise State University, and Associate degrees in Architectural Engineering and Building Technology from Vermont Technical College. He has been a long time ISPE member.

REGISTRATION FEES:

Before 2/12/2015: 

Member $50.00  
Young Professional Members $20.00 
Non-Member $95.00**
ISPE Student Members: Free to attend
Warwick Location: FREE
WPI BETC Location: FREE 

After 2/12/2015: 

Member: $60.00
Young Professional Memebers $30.00 
Non-Member: $115.00**
ISPE Student Members: Free to attend
Warwick Location: FREE 
WPI BETC Location: Free

 

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

 

MEETING MANAGERS:

Maurizio Cattaneo, BioVolutions
Terry Butler, Hallam-ICS
Nonjaros Chomcharn, Lyne Labs
Sean Brown, Barry Wehmiller

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ISPE Young Professionals Committee Meeting
Date: 26 February 2015

If you have any questions regarding this committee meeting, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 2 March 2015

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 March 2015

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: 6 March 2015

Join ISPE for the Chapter's Annual Ski Trip on March 6, 2015 at Waterville Valley.  Space is Limited, so Don't Delay!

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

Note: Books of 4 Tickets are available for $265.  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: 7:00 PM: to all Departure Sites (Concord, Andover, Newton)

Thanks to our Ski Trip Sponsors: 

A/Z Corporation
Bard, Rao + Athanas Consulting Engineers
Commissioning Agents Inc.
GxP Automation 
Perkins + Will
Superior Controls
T & M Associates
UltraFiltronics

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ISPE Board of Directors Meeting
Date: 10 March 2015

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 Risk Based Reality
Date: 19 March 2015

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ISPE Young Professionals Committee Meeting
Date: 25 March 2015

If you have any questions regarding this committee meeting, please call the office at 781-647-4773.

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ISPE Educational Programs Planning Meeting
Date: 1 April 2015

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 April 2015

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 April 2015

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 Productions Systems, Single Use
Date: 16 April 2015

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ISPE 2015 Student Poster Contest
Date: 16 April 2015

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 Philadelphia, PA. on November 8-11, 2015. 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  

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ISPE Young Professionals Committee Meeting
Date: 30 April 2015

If you have any questions regarding this committee meeting, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 4 May 2015

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 May 2015

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: 11 May 2015

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.

To sponsor this event click here.

To sign up for a foursome click here. 

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ISPE Board of Directors Meeting
Date: 12 May 2015

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 Engineering and Project Management
Date: 21 May 2015

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ISPE Young Professionals Committee Meeting
Date: 27 May 2015

If you have any questions regarding this committee meeting, please call the office at 781-647-4773.

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ISPE Product Show Committee Meeting
Date: 1 June 2015

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 June 2015

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 June 2015

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 Tech Transfer: How to Manage Your Relationship with a CMO
Date: 18 June 2015

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ISPE Product Show Committee Meeting
Date: 13 July 2015

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 July 2015

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: 16 July 2015

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: 3 August 2015

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: 5 August 2015

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: 11 August 2015 - 12 August 2015

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: 17 August 2015

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: 2 September 2015

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 September 2015

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: 14 September 2015

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 Regulatory Compliance
Date: 17 September 2015

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ISPE Product Show Committee Meeting
Date: 28 September 2015

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 Annual Product Show and Educational Seminars
Date: 7 October 2015

Save the Date for the 24th Annual Product Show!

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ISPE Annual Product Show and Educational Seminars
Date: 7 October 2015

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ISPE Board of Directors Meeting
Date: 13 October 2015

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: 21 October 2015

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 Educational Programs Planning Meeting
Date: 4 November 2015

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 Soft Skill: Death by Powerpoint
Date: 12 November 2015

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ISPE Board of Directors Meeting
Date: 17 November 2015

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: 2 December 2015

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: 7 December 2015

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 December 2015

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 Information Systems
Date: 10 December 2015

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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 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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Page last updated: 26 June 2014