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Event

Boston Seminar on Surviving an FDA Inspection: Understand the Do's and Don'ts an

This seminar provides background and understanding of the role played by the Agency, its administrative and enforcement powers.

Overview: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. Who will benefit: This seminar will provide valuable assistance and guidance to all regulated companies that are preparing for FDA inspections. 

When

10 Dec 2015 @ 09:00 am

11 Dec 2015 @ 06:00 pm

Duration: 1 days, 9 hours


Where

Courtyard Boston Logan Airport

225 William F McClellan Highway

United States


Language

Englishen


Organised by

GlobalCompliancePanel (deactivated)

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