New GAMP Data Integrity Good Practice Guidance and ... - ISPE

New GAMP? Data Integrity Good Practice Guidance and Experience from the Field

Speakers

Sion Wyn

Director, Conformity Ltd.

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

Sion 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 Moody

Director, Supplier Quality, Alexion Pharmaceuticals, Inc.

Paul is a well-known and respected specialist in lifescience regulations. He (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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New GAMP? Data Integrity Good Practice Guidance

Sion Wyn Director, Conformity Ltd

Overview

Background and context - ISPE GAMP? Guidance on DI Update on published and planned guidance Some highlights and selected topics

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GAMP? Guide: Records & Data Integrity

Published March 2017

Stand-alone Guide, aligned to GAMP 5

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