CoP Session: GAMP
2:15 PM – 3:00 PM | Red Level Press Box
Do Vendor Audits & Quality Agreements really matter in a Cloud-Oriented GxP Environment
This presentation aims to provide insights into the essential role of vendor audits and quality agreements in maintaining compliance with regulatory requirements and ensuring data integrity when cloud-based solutions are used for managing GxP processes and supporting GxP decision-making.
Speakers:
Geetanjali Abbi, Head of Digital Quality, Alkermes
Tammy Hanley, Senior Quality Systems Analyst, Sanofi
Biographies:
Geetanjali Abbi, Head of Digital Quality, Alkermes
Geetanjali (Geetu) is an experienced leader in Computer System Validation & Compliance, with over 17 years of expertise. Graduating from DIT University in India with a degree in Information Technology in 2002, she began her career focusing on software quality as a Testing Lead before transitioning to CS Validation. She has led numerous successful projects across Manufacturing, Quality Systems, R&D, IT, and Labs. Currently, she heads the Digital Quality Assurance organization at Alkermes and leads a global team. Passionate about continuous learning, she encourages innovation & risk-based strategies.
Geetu is a member of the GAMP Americas Steering Committee and leads ISPE GAMP Boston CoP. She also coauthored the ISPE’s GPG Validation and Compliance of Computerized GCP Systems and Data.
Tammy Hanley, Senior Quality Systems Analyst, Sanofi
Tammy Hanley has worked for Sanofi since 2002, starting as a Senior Quality Systems Analyst and Part 11 Project Manager. Over the years, she has held numerous positions in Quality and Digital Compliance.
For the past six years, Tammy has been an integral part of the Global Quality Audit team, where she has made significant contributions in various areas including auditing digital systems, medical devices and sites for computerized system compliance, mentoring colleagues in computerized systems, collaborating on the development of remote audit methodology during the pandemic for business continuity, and providing support for regulatory inspections through mock audits or back-room assistance.
Now based in Framingham, Massachusetts, Tammy currently serves as the Head of Performance, Insights and Transformation in the Sanofi Quality Audit Inspection Intelligence and & Advocacy team. Tammy and her team are fostering best in class performance by leveraging data, technology, and diverse talents to secure product launches and support compliance through audits, inspections, regulatory surveillance and advocacy.
In 2024, Tammy was selected to join the Steering Committee of the ISPE Boston GAMP Community of Practice (CoP). Her expertise and dedication to the fields of Computer System (CS) Validation, Compliance, and Data Integrity (DI) have been widely recognized.
