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International Recognition
FDA Group Recognition Award Sion Wyn has received the FDA Group Recognition Award for the preparation and publication of the new 21 CFR Part 11 Guidance for Industry: Part 11, Electronic Records; Electronic Signatures - Scope and Application. Working under stringent deadlines, the Part 11 Workgroup worked diligently to align the Part 11 regulations with the goals of the FDA's cGMPs for the 21st Century Initiative. The team first published a draft in February 2003, then a final guidance addressing issues of concern to industry in September 2003. The guidance outlines a risk based approaches to these issues. The Award was signed by the FDA Commissioner and presented during the CDER Fall Honor Awards. ISPE honours work on GAMP® Guidance Colin Jones has been honoured by ISPE for his work on GAMP® Guidance and recognised by a plaque bearing the inscription: For
outstanding service and leadership in the creation of the The ISPEGAMP® Good Practice Guide (GPG): A Risk-Based Approach to Compliant Electronic Records and Signatures provides comprehensive guidance on applying a risk-based approach to meeting current international regulatory expectations for compliant electronic records and signatures. Further information onGAMP® Guidance may be found on the ISPE website. |