New GAMP® Data Integrity Good Practice Guidance & Experience from the Field Webinar

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:

  • Overview of ISPE GAMP® Data Integrity Good Practice Guidance
  • Experiences from the field
    • Regulatory perspective
    • Citations and problem areas
    • Remediation actions
    • Practical strategies
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Meet the Presenters:

Speaker

Sion Wyn, Director, Conformity Ltd., is a well-known and internationally acknowledged specialist in computer systems validation and compliance and life-science regulations in this field. 

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.


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Paul Moody
Director, Supplier Quality
Alexion Pharmaceuticals, Inc.
Speaker

Paul Moody, Director, Supplier Quality Alexion Pharmaceuticals, Inc. is a well-known and respected specialist in life-science regulations.  

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. 

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