FDA Speaker Draws Large Crowd at 2024 GAMP Forum

The GAMP Community-of-Practice and Educational Programs Committee recently hosted the GAMP 2024 Forum on June 6th at the Alkermes office in Waltham. Nearly 100 attendees gathered for an afternoon of all things GAMP! Amidst networking opportunities and tasty snacks, attendees got an overview of upcoming GAMP publications, a panel discussion on critical thinking and risk-based approach to computer system validation, vendor qualification and quality agreements for cloud XaaS suppliers, challenges with implementing AI, and a fireside chat with the FDA! There were questions abound throughout the afternoon, highlighting the growing interest in GAMP in the Boston area. The afternoon concluded with a networking social down the street at the local Craft Food Hall.

The session commenced with Christopher Ciampa from CAI doing the opening remarks and kicking off the event. Retired Data Integrity SME Lorrie Schuessler discussed the latest GAMP Global publications and highlighted the GAMP ML Risk & Control Framework published in January/February 2024 edition of Pharmaceutical Engineering magazine, She also mentioned the upcoming released of revised GAMP Good Practice Guide: GCP which offers recommendations for addressing the challenges and solutions of integrating AI systems in clinical trials and decentralized clinical trials.

In a panel discussion with the FDA, Seneca Toms, alongside other experts, highlighted the role of GAMP guides in standardizing industry practices and emphasized the importance of robust data management to ensure accuracy, integrity, and compliance. The panelists, including Seneca Toms, Geetanjali Abbi, Stephen Ferrel, Heather Longden, Lorrie Schuessler, and Brandi Stockton, stressed the significance of quality culture in achieving mature quality systems. They underscored the shift in GAMP 5 2nd Edition towards critical thinking in overall validation approach including test development planning, advocating for a strategic approach over mere execution for better outcomes.

Geetanjali Abbi and Stephen Ferrell’s discussion on vendor qualification and quality agreements for cloud PaaS/IaaS/SaaS suppliers focused on the strategic use of Master Supplier Agreements and Quality Agreements as outlined in GAMP 5 (Chapter 7). Geetanjali emphasized the necessity for clearly defined roles and responsibilities in quality agreements, highlighting key requirements such as audit provisions and backup/recovery protocols to ensure accountability and robust risk management throughout the product development lifecycle. Stephen elaborated on the importance of data security and integrity, stressing vendor compliance with standards like ISO 27001, HITRUST CSF, SOC2, and ISO 27017. Their joint talk illustrated the need for a comprehensive understanding of business processes to identify risks, accountabilities, and data flow, thereby enhancing the clarity and efficiency of operations.

The final educational session of the workshop was Brandi Stockton’s presentation on the challenges of implementing AI. She provided insights on control frameworks, emphasizing critical thinking, risk management, and alignment with ICH Q9 (R1) for integrating AI in pharma systems. Using case studies from Charles River, Brandi discussed model characteristics and data quality requirements.

The event concluded with a fireside chat featuring Seneca Toms and Heather Longden, where they shared real-world examples and insights on developing and maintaining compliant systems, FDA expectations, and Seneca’s journey in the industry and at the FDA. This session offered a relaxed yet informative end to a highly engaging workshop.

Thank you to all of our guest speakers, Lorrie Vuolo-Schuessler (GAMP Trainer, Retired SME), Stephen Ferrell (Strike Graph), Brandi Stockton (The Triality Group), and LT Seneca Toms (US FDA)! This program would not have happened without your expert contributions.

Interested in joining the Boston GAMP Community-of-Practice? Reach out to the co-chairs Geetu Abbi, Heather Longden, or Chris Ciampa!

Stay tuned for the next EPC program on July 25th: Users and Providers: A Workshop of Exploring the Dialogue of Documents