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Name: FDA: Current Inspections Case Review ( WEBTPAFDAI )
Description: Industry experts discuss current inspection findings, expectations for GMP and quality systems, the quality of the supply chain by adequate qualification of vendors and contract manufacturers, expectations of management, and CDERs Part 11 inspectional assignments.
Objectives: At the conclusion of this course, participants will understand:
  • FDAs insight and manufacturing risks
  • View real examples of FDA and undustry interactions
  • View case that led to: Form 483 citations, withholds and pending applications, warning letters, recalls, market withdrawals, consent decreases, seizures, shutdowns, firms going out of business, and criminal investigations
  • URL:
    CEUs: .05
    Member Price: US Dollar        EURO
    Non Member Price: US Dollar        EURO
    Instructors:
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