Reducing your Exposure to a GMP FDA Warning Letter 2015

Topics

• What should always exist during an inspection?
• How to prepare for inspections
• How can you reduce your risk for a Warning Letter?
• What systems will get the greatest attention from a regulatory agency?
• What do you do after receiving a 483 observation?
• How does past regulatory history impact your future?
• How do you determine if a serious risk exists?

Who should Attend

Attendees from:

• Quality Assurance
• Quality Control
• Laboratory
• Production
• Distribution and even Development personnel that are Supervisory
• Warehousing
• Management or directly performing regulatory related activities or support