FDA Inspection Readiness Training for Boehringer Ingelheim, Germany

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PCS provided a two-day training on FDA inspection readiness. Topics included; the regulatory background to FDA inspections and new FDA policies, types of inspection, internal preparations for inspection, managing an FDA inspection, the “483” document and post-inspection actions, the Warning Letter – Regulatory impact, FDA investigators – a profile, documentation required for Preapproval Inspections, FDA inspection – current hot topics, FDA expectations for: OOS and failure investigation, Environmental control, Equipment qualification and validation, Change control, Quality control laboratories and case studies.

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