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Name: FDA CDER Announces Part 11 Inspectional Assignments ( WEB21CFRINSP )
Description: With the use of multi-product facilities, the risk of cross contamination increases. By properly managing the risk of cross contamination manufacturers can reap the benefit of lower cost and higher efficiency while maintaining product quality and patient safety.
Objectives:
  • Understand the very latest progress in FDA’s examination of 21 CFR part 11
  • Prepare for the CDER inspectional initiative
  • Assess their own organization’s level of compliance and readiness
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