CoP Session: GAMP
2:00 PM – 2:30 PM | East Red Level, Suite 20
GAMP
The GAMP community in Boston is growing strong, supporting the global ISPE GAMP CoP (Community of Practice) work to educate, solve challenges and embrace new concepts in Computer Systems Validation (CSV) and Data Integrity (DI). In this session the GAMP Boston CoP co- leaders leads will share the resources available to our community to navigate a changing world and provide an update on our recent successful GAMP Forum, co-hosted by the local Education Program Committee (EPC).If that isn’t enough acronyms, this session will touch on AI/ML, quality in SaaS and IaaS environments, the collaboration of the FDA and CDER, and how the CSA initiative from FDA CDRH is driving a fresh look at what an ICH Quality landscape embraces a risk-based approach to validation. Mark the session in your event calendar to find out more and how you can get involved with local ‘regulated data’ practitioners.
Speakers:
Geetanjali Abbi, Head of Digital Quality, Alkermes
Heather Longden, retired Data Integrity SME
Biographies:
Geetanjali Abbi, Head of Digital Quality, Alkermes
Geetanjali Abbi is a pragmatic leader and a champion in Computer System Validation & Compliance with more than 17 years of experience. Geetu graduated from DIT university in India in 2002 with a degree in Information Technology. From the beginning she is more curious on the quality aspect of the software and started her journey as Testing Lead and transitioned to a career in CS Validation. Throughout her journey she has accomplished numerous projects in areas ranging from Manufacturing, Quality Systems, R&D, Information Technology and Labs. Today, she leads a global team and manages CSV quality process at Alkermes. She is a big proponent of continuous learning and improvement and challenges herself and her team, to think outside the box and develop effective risk-based strategies that fits systems of all facets.
Heather Longden, retired Data Integrity SME
Heather Longden has over 30 years’ experience at a major supplier to the life sciences industry as a key resource to their customers on all regulatory evolution related to quality laboratories. Her career began in technical support and software training in the UK but evolved into a key global role at the headquarters in Milford MA. In this role Heather led the ERES (electronic records and electronic signature) Compliance strategy at Waters collaborating with regulators and life science customers to set a direction for SMEs across the globe and corporate headquarters teams- including software development. Although enjoying her recent retirement from professional life, Heather continues to engage in ISPE activities and leadership, specifically at the Boston Area chapter EPC (education program committee) and in the GAMP Community of Practice (COP). She is relied on as an essential connector for regulatory and industry speakers and contributors for the education committee. Heather also serves on the GAMP Americas leadership team and was the global GAMP representative on the Knowledge Network committee for a couple of years. Heather believes passionately that, as the life science arena transforms digitally, that data engineers and data quality are key challenges and opportunities that ISPE are uniquely positioned to excel at and therefore to empower our members at both a global and Boston Area level.
