Since the original publication date of GAMP 5 in 2008, the application and use of technology has advanced substantially. GAMP 5 Principles and Framework remain applicable and relevant today. This session will be a Q&A for delegates to ask questions of Regulators, and presenters from the GAMP track to focus on gaining an oversight of how GAMP 5 Second Edition provides practical updates of the application of GAMP 5 principles and framework, including Critical Thinking, Artificial Intelligence (AI), Computer Software Assurance (CSA), etc., to define appropriate approaches and exploring the relationship between the GAMP validation framework, data integrity and current regulatory thinking e.g., FDA CDRH Case for Quality program, etc.
Speakers:
Khaled Moussally
Executive VP Quality – Clients & Regulatory Relations at Compliance Group Inc
Martin Benedikt Heitmann
Manager, d-fine GmbH
Arno Terhechte
Inspector RPharmD, Bezirksregierung Munster
Ib Alstrup
Medicines Inspector, GxP IT, Danish Medicines Agency
Guy Wingate, PhD
Independent Consultant, Glaxosmithkline PLC (Retired)
Sion Wyn
Director, Conformity Ltd.