Getting Ready for An FDA Inspection

Felicia Angus

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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
Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Felicia Angus, 23 years of pharmaceutical experience

elicia Angus is passionate quality professional with over 23 years of pharmaceutical experience in the clinical, solid dosage, API, sterile and biological industries and over 6 years of vendor management experience. As a Supplier Relations Team Leader, Felicia is passionate about quality and ensuring every individual at a manufacturing site is prepared for any situation. She is a subject matter expert in executing and monitoring compliance to FDA, EMA, DEA, Canadian, Japanese, Swedish, and ICH and 21CFR820 regulatory requirements. Felicia Angus is the CEO of Quality Culture Champions, LLC ensuring a positive quality culture is embedded into any organizations.

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