The Center for Professional Advancement (CfPA) is presenting, Managing FDA Inspections: The FDA Investigator Cometh...Are You Ready?, a free, 60-minute webinar, March 31, 2011, from 11:00am-12:00pm (ET).
The webinar presents a brief overview of the Agency role and authority and the types of inspections performed. It also outlines basic strategic steps to be taken by companies in order to get ready and successfully managing FDA inspections whether at a U.S. or a non-US site.
Topics covered during this webinar include:
• Agency role - administration and enforcement powers
• Pre-approval & routine inspections
• How firms prepare for inspections
• Successfully managing the inspection
• Understanding the inspection process
• Entrance conference
• Conduct of inspections
• Exit conference
• Enforcement tools
• Responding to 483's - follow-up
Presented by: Renée B. Galkin, quality management consultant
Register here. Use Priority Code 2055 when registering.
If you can’t make the live date, send an email to [email protected] with subject line "#2406 On-demand" and you will be notified when the on-demand version is available.
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