FDA requirements regarding Good Manufacturing Practices (GMP) and related inspections have been around for decades. However, GMP deficiencies are still among the most cited reasons for regulatory action. Often, simple proactive steps can be taken to strengthen GMP programs, resulting in compliant operations which will stand up to regulatory scrutiny. This 90-minute course will provide you with the tools to safeguard against inspection deficiencies and satisfy regulatory agencies that your efforts are compliant.
By attending this course, you will learn:
- Tips & tricks to prepare for – and survive – a FDA GMP inspection
- The top five issues inspectors look for and how to avoid them
- Actionable steps that will allow you to be prepared for ANY contingency
- How to respond to inspection findings and avoid further regulatory action
- Communicating with the FDA – what to say, what not to say, and when to say it