This webinar provides an overview of new and forthcoming ISPE GAMP® Data Integrity guidance and real-world experiences on applying data integrity in the field. The speakers will address the following topics:
Sion is the Editor of the ISPE GAMP 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems and received the 2006 ISPE Professional Achievement Award for his work.
He assisted the US Food and Drug Administration (FDA) as a consultant with its re-examination of the 21 CFR Part 11 regulation on electronic records and signatures and was a member of the core team that produced the FDA Guidance on 21 CFR Part 11 Scope and Application.
Paul (ex HPRA) has over 20 years’ experience within the pharmaceutical and medical device sectors with expertise in the area of pharmaceutical regulation including data integrity.