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ISPE Boston GAMP 5 Forum

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ISPE Boston GAMP 5 Forum


ISPE Boston's Good Automated Manufacturing Practice (GAMP) 5 Forum Program

NEW SPEAKERS JUST ANNOUNCED FROM THE FDA!!


WHEN:   August 18, 2022 | 1:30pm - 7:00pm

WHERE: Courtyard by Marriott Boston Cambridge
             777 Memorial Drive

             Cambridge, MA 02139

PROGRAM DETAILS:

After celebrating GAMP’s 30th anniversary in 2021, the GAMP Global Steering committee and ISPE are proud to present the Second Edition of GAMP® 5 which will be available Summer of 2022.  GAMP 5 Guide–A Risk-Based Approach to Compliant GxP Computerized Systems was initially published in 2008. A GAMP 5 Second Edition has been developed based on comprehensive reviews of GAMP 5 content performed in 2017 and early 2020 by the GAMP CoP Global Steering Committee and the GAMP CoP ERB (Editorial Review Board).

The primary purpose and objective of this revision is to provide updates, clarify the relationship between GAMP 5 and the GAMP® 5 Guide: Records and Data Integrity, acknowledgment of current FDA work on computer software assurance (CSA), and an updated, dynamic, and evolving set of Appendices. 

Join the ISPE Boston Chapter Educational Program on August 18th in Cambridge, MA to learn more about how volunteer experts and regulators from the ISPE family collaborate through GAMP on a range of software and computerized systems challenges in a highly quality driven and regulated space. Hear from contributing authors, reviewers, and the editorial team about the highlights of this second edition. 

We also hope to shortly confirm a lively panel discussion with two invited FDA speakers from CDER and CDRH, who are both passionate about risk-based Validation of software and have worked closely with the editorial team on the upcoming ISPE guide. 


AGENDA:

1:30pm Welcome
Overview of the ISPE GAMP Community of Practice
Overview of the ISPE GAMP® 5 Guide, 2nd Edition
Panel Discussion on critical thinking and risk-based approach to computer system validation (FDA invited)
ISPE GAMP® 5 Guide, 2nd Edition new chapters/appendices on critical thinking and risk-based testing
How to be involved in ISPE GAMP, Special Interest Groups, and local Communities of Practice
5:30-7:00pm Networking Session


SPEAKERS:
Lorrie Vuolo-Schuessler is Senior Director of Computer Systems Quality and Data Integrity at Syneos Health providing support and consultation to internal and external business partners to assist them in meeting global regulatory and data integrity requirements for computerized systems. Lorrie has been involved with ISPE and the GAMP Community of Practice leadership since 2002. She is currently Chair of the GAMP Americas Steering Committee and a member of the GAMP Global leadership team. She has contributed to the development of the GAMP 5 2ed A Risk-Based Approach to Compliant GxP Computerized Systems and the ISPE GAMP Good Practice Guide (GPG): Enabling Innovation - Critical Thinking, Agile, IT Service Management. She is a co-leader of the recently formed Computer Software Assurance (CSA) Special Interest Group (SIG) and drove the data integrity efforts within GAMP as the co-chair of the recently sunsetted GAMP Data Integrity SIG. The Data Integrity SIG developed multiple GPG’s including: the ISPE GAMP RDI GPG: Data Integrity by Design, the GAMP RDI GPG: Data Integrity – Manufacturing Records, the ISPE GAMP RDI GPG: Data Integrity – Key Concepts, and the ISPE GAMP Records and Data Integrity Guide. Additionally, she has contributed to multiple ISPE/GAMP webinars, expert exchanges, and trainings.

Khaled Moussally, EVP Client & Regulatory Relations, Compliance Group Inc. Khaled is a Quality / IT executive who partners with clients from the Pharma, Biotech and Medical Device industries to deliver solutions to their IT / Engineering quality and compliance related challenges. After spending over 27 years in IT, Manufacturing and Quality, 19 years of which at Baxter Healthcare, Khaled understands the regulated environment and is able through his deep experience and valuable network to provide his expert advice. Khaled is a contributor to the MDIC “Case for Quality Initiatives” and an active member of the “FDA CSA Industry team” (FICSA), contributed countless recommendation to the FDA draft guidance on “Computer Software Assurance (CSA) for Manufacturing, Operations, and Quality System Software”. Khaled has presented in numerous seminars along with the FDA & Industry leaders on how to reduce time and cost in validating software by applying CSA Draft guidance. Khaled is a member of GAMP Americas Steering Committee, contributor to both, Good Practice Guides on DI by Design and Enabling Innovation and GAMP 5 2nd Edition.

NEW CONFIRMED SPEAKERS:

Seneca D. Toms, National Drug Expert, Drugs, U.S. Food & Drug Administration (FDA)

Francisco Vicenty, Program Manager, Case for Quality, U.S. Food & Drug Administration (FDA)


REGISTRATION FEES:

Early Bird (Ends 08/11/2022)
Member: $125
Non-Member: $195
ISPE Young Professionals Member: $65
Student: FREE

After 08/11/2022
Member: $135
Non-Member: $210
ISPE Young Professionals Member: $70
Student: FREE

PARKING INFORMATION:

Courtyard by Marriott Boston Cambridge offers valet parking at a rate of $45 per night or you can park your car in the adjacent garage at a rate of $40 for 24 hours. If you are planning on taking your car in and out multiple times during your stay, then valet parking is the less expensive alternative. Street parking is free between 8pm and 8am and all day on Sundays.

Thank you to our wonderful sponsors:


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Event Date: August 18, 2022 1:30 pm — August 18, 2022 7:00 pm
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