US FDA to Discuss the Part 11 Inspection Assignment at ISPE Washington Conference

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The US FDA will be present to discuss the long awaited next step Part 11 Inspection Assignment. This means that you will be the first to hear how FDA will focus on Part 11 controls during inspections. The industry has had since August of 2003 to understand how the US FDA intends to enforce Part 11 as per the guidance and be in compliance. Therefore, the intention of CDER to take appropriate enforcement action should not be a surprise, but it will be important to understand their approach.

To hear this presentation attend Seminar E07 GAMP Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems, 9-10 June 2010, at the ISPE Washington Conference. The presentation will be given by George Smith, Project Manager Officer, CDER, US FDA and Sion Wyn, Consultant, Conformity, Ltd., member of core Part 11 team.

As the next step of their re-examination of 21 CFR (Part 11), US FDA CDER will begin a human drug inspectional initiative against Part 11 requirements as described in the Part 11 Scope and Application guidance published in August of 2003. This effort will be part of CDER’s effort to evaluate industry’s compliance and understanding of Part 11 in light of the enforcement discretion described in the scope of application guidance.

CDER intends to use the inspectional findings to help assess how to proceed with regard to the possible modification of Part 11. CDER intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections.

Last Update: 26 August 2011

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