Best Practices for Managing FDA Investigators and Handling FDA 483 Observations

September 30, 2010(Ended)
Online Webinar
Best Practices for Managing FDA Investigators and Handling FDA 483 ObservationsThis course offers a unique perspective and is a succinct overview of best practices that can really help you avoid these compliance situations, described above

Areas Covered in the Seminar:
  • Inspectional preparations and logistics.
  • Manage the FDA Investigator for the best outcome.
  • Influence FDA decision-makers.
  • Properly accept FDA 483.
  • Respond strategically to FDA 483.
  • Develop a strategic Corrective Action Plan.
  • Intercept and Avoid a Warning Letter.

Who Will Benefit:
  • Executive Managers faced with a future FDA inspection
  • Personnel with direct and indirect FDA contact prior, during, and after a FDA inspection
  • Quality Assurance managers and personnel
  • Regulatory Affairs and Compliance managers and personnel
Prices *
199-199 US Dollar
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* Prices are for evaluation only.