2-day In-person Seminar on “Why is FDA at my Facility, and What do I do During an Inspection” at Washington DC

Course "Why is FDA at my Facility, and What do I do During an Inspection" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

10 11 October 2013

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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.

The employees who will benefit include:
•All levels of Management for all departments
•QA/QC/Compliance/Regulatory Affairs
•Information Technology/Marketing & Sales
•Engineering/Technical Services/Validation
•Operations and Manufacturing

1 speaker

2 sessions

Day 1 from 9am to 6pm Thursday 10th October 2013

Day 2 from 9am to 6pm Friday 11th October 2013

Courtyard Washington Capitol Hill/Navy Yard

United States United States

140 L Street SE Washington, District Of Columbia 20003 USA, 20003

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2 known attendees

  • GlobalCompliancePanel
  • David Dills

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