How to prepare for and host an FDA inspection and respond to 483’s

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OVERVIEW
In this webinar you will learn about the types of FDA inspections, preparations such as assigning personnel to specific tasks for the FDA inspection, facility requirements to support the inspection (front room, back room), the value of mock audits, how personnel should conduct themselves during the inspection, the inspection process and techniques for responding to 483s and warning letters. How to respond and when is critically important. Also covered will be the FDA’s rights during the inspection and documentation you are not required to show them.
WHY SHOULD YOU ATTEND
FDA is required to conduct an inspection every two years. A company that is prepared for the inspection is less likely to…

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Актуальные книги на английском