FDA has announced their intention to increase manufacturing regulatory inspections in 2015. Inspectors can – and will – ask to talk to anyone in your facility about the GMP operations they perform or support. Many people fear interacting with a regulatory inspector. Are your personnel up to the challenge? Do they know what to do when they’re asked to speak to the inspectors? Can they do it successfully? How your people interact with the inspectors does a lot to set the tone for the inspection. Are you prepared to have the best possible experience?
By attending this interactive session, you will discover how to prepare your people to successfully talk to regulatory inspectors. Specifically, you will:
- Learn to identify potential areas of risk to your company, and how to prepare for them
- Identify the right personnel to address specific topics
- Understand the “do’s and don’ts” for answering inspector questions
- Develop personnel confidence in advance of facing an inspector – which also benefits the inspection hosting process
FDA GMP inspections can be a daunting process for the uninitiated. This course will help you prepare your entire staff to be prepared for almost any eventuality.