Getting Ready for an FDA Inspection
Duration : 60 Minutes
Felicia Angus, 23 years of pharmaceutical experience
Felicia 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 ma Read more
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
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
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
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
