Why is FDA at my Facility, and What do I do During an Inspection
This event qualifies for 12 RAPS
Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions.
This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer.
This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters.
Emphasis is placed on the company's SOP on dealing with inspectors and knowing how to be prepared, proactive...and being able to defend and justify... and what it takes to achieve a favorable outcome.
This seminar provides background and understanding of the role played by the Agency, its administrative and enforcement powers. It takes the participant step by step through the entire inspection process and describes various types of inspections.
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Speaker and Presenter Information
David R Dills - Regulatory Affairs & Compliance Consultant,
David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space.
Expected Number of Attendees
50Relevant Government Agencies
Dept of Agriculture, Dept of Education
This event has no exhibitor/sponsor opportunities
When
Thu-Fri, Jul 21-22, 2016, 9:00am - 6:00pm
Where
To Be Announced
Zurich, Switzerland CH
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Website
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Organizer
GlobalCompliancePanel
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