483 Observation Gotchas!
1. Deviation reports failed to include a discussion of product impact.
2. Investigation reports stated this was an isolated incident, yet the database revealed 13 similar incidents.
3. Investigation reports failed to provide data to support the root cause determination
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About Your Instructor
Allan Dewes has been teaching others to write deviation investigation reports for over 15 years. Allan understands CGMP regulations, the FDA expectations for deviation investigation reports, and how to coach others to write a quality document.
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