Are you ready for the next FDA inspection? – Inspection Readiness Preparation
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Have you done everything you can to prepare for your next FDA Inspection? Do you have an SOP for Regulatory Inspections? Do your employees know what to do when they get that phone call from security or a receptionist? Who should security/receptionist call when FDA arrives unannounced at your firm? That’s right, FDA does not schedule an inspection – they just show up, present their credentials and state we’re her for an inspection.
Don’t panic! Be prepared! Learned how to write an SOP for FDA Inspections. Make sure your people are adequately trained on this SOP so they don’t “freak-out” when two, three or four FDA Investigators surprise you.
Areas Covered in the Session :
- How to write an SOP for FDA Inspections
- Checklist to ensure you are ready for FDA Surprise Inspections
- Appropriate behavior during FDA and other Regulatory inspections
- How to respond to questions
- What to say, how to say it, what you should NOT say
- Where you should have FDA stay while they are on-site
- Preparation and Organizing right Documents
- Deviations, OOS and Complaint Investigations
- Organizing Master Production and Batch Production Records for review
- Organizing and preparation of stability studies for scrutiny by FDA
- Facility and Equipment maintainance
Who Should Attend:
- Quality Assurance Departments
- Quality Control Departments
- Regulatory Affairs Departments
- Research and Development Departments
- API Manufacturers
- Compliance Departments
- Contract Manufacturing Organizations
- Contract Testing Laboratories
- Operators and facility/maintenance professionals
- Security and Receptionists
Course Director: BRIAN G. NADEL
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