FDA’s New Inspectorate Re-Org to Put Pressure on SMEs - Webinar CD/Transcript
FDA’s New Inspectorate Re-Org to Put Pressure on SMEs
If you think your Subject Matter Experts are stressed out now … then get ready for what's to come.
FDA’s new plans to create specialized teams of investigators — their composition and expertise based on your specific products — are going to put more pressure on SMEs than ever before. Are your SMEs ready?
It's not just about logistics any more – how you greet the investigator at the front door, should you offer him/her a glass of water or how many copies of key documents to make. The stakes are much higher.
In just 90 minutes, you'll learn best practices and key points to ensure you have fully prepped your SMEs to address questions from the new specialized inspection teams.
You'll be taught the fine points of how to develop a comprehensive strategy based on assessed risks and train your SMEs to address these risks with the investigation team. You'll learn such specifics as how to:
- Ensure your SMEs are aligned to the topics they are going to be asked the most
- Improve SME effectiveness by conducting thorough simulated inspection scenarios
- Satisfactorily answer questions commonly asked by investigators
- Avoid providing “extra information” that was not required to answer a question
- Successfully push back against FDA investigators' requests for documents
- Avoid angry responses, body language and tone of voice that can derail interviews
- And much more