CoP Session: GAMP CoP & GAMP Boston Local CoP Formation
11:30 AM – 12:00 PM | West Red Level, Suite 70
This session will share the excellent collaboration of the GAMP Community and its contribution to the pharmaceutical industry in the area of Computer Excellence and Quality, through expert guide publication and insightful and timely articles. While regional and global GAMP communities focus in Industry-wide needs, in Europe and Asia, local communities work within the ISPE Affiliates to provide for the needs of specific countries, specifically to connect in local language and facilitate face to face activities. Now, ISPE Chapters will join the affiliates with the formation of the first Chapter level COP, ISPE GAMP Boston, within the ISPE Boston Chapter.
Speakers: Heather Longden, SME in Data Integrity Geetanjali Abbi, Head of Digital Quality, Alkermes
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 as they collaborated with regulators and life science customers, setting a direction for SMEs across the globe and corporate headquarters teams- including software development.
Geetanjali Abbi (Geetu) is a highly experienced leader in Computer System Validation & Compliance, with over 16 years of industry knowledge. Currently serving as the Head of Digital Quality at Alkermes, she oversees a global team and strongly emphasizes the importance of continuous learning and improvement. She encourages her team to think innovatively and create effective risk-based strategies.
Geetu graduated from DIT University in India in 2002 with a degree in Information Technology. Her passion for software quality led her to begin her career as a Testing Lead, later transitioning to CS Validation. Throughout her professional journey, she has been a strong advocate for Quality by Design (QbD) and has successfully delivered numerous digitalization projects in areas such as manufacturing, quality systems, clinical, information technology, and labs.