Getting Ready for an FDA Inspection



Speaker : Felicia Angus

Felicia Angus is passionate quality professional with over 23 years of |  more...

Topic ID : 1294

Duration : 90 Mins

Live : Coming Soon..

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Course Description:

If you’re in the business of manufacturing drugs, medical devices, nutraceuticals, or manufacturing or importing any product in the United States that falls under current Good Manufacturing Processes (cGMP) regulations, your facility will be inspected by the U.S. Food and Drug Administration (FDA). This presentation will get you ready for an FDA inspection which includes: Task to complete before an unannounced inspection, conducting a regulatory agency inspection, and after the inspection.

Course Objective:

Preparation Before an inspection

  • Inspection Room and Command Center Team
  • Supplies need in the Command Center Training
  • Information & Communication
  • Security

During an Inspection
  • Information and Communication
  • How to answer questions
  • Inspection Etiquette (Hospitality)
  • Security

After the Inspection
  • Information and communication
  • Security
  • Housekeeping

Course Outline:

Topics covered include:

  • Documentation
  • Internal Audits
  • Training
  • Maintenance
  • Warehouse
  • Housekeeping
  • Plant Walk troughs
  • Communication
  • Quality Oversight

Target Audience:

This webinar will provide valuable assistance to all personnel in:

  • Regulatory Affairs Managers
  • Quality Assurance Managers
  • Audit and Compliance Personnel / Risk Managers
  • Manufacturing Managers
  • Compliance Department Personnel
  • Maintenance Personnel
  • Security Professionals

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