FDA’s New Inspectorate Re-Org to Put Pressure on SMEs - Webinar CD/Transcript

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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
  • Compliance personnel
  • Regulatory affairs professionals
  • QA/QC personnel
  • Potential SMEs for inspection

Joanne Cochran is President of JWC Training Associates and an instructional designer with extensive experience in designing, developing, and delivering effective regulatory GMP compliance training to all levels of personnel within the pharmaceutical and medical device industries. Expertise includes delivery of diverse regulatory and technical programs at both domestic and international sites. Particular strength in creating effective training instruments to convey complex concepts in understandable terms to all levels within the organization. Early background includes technical experience in both research and quality operations. For one of the top 10 pharmaceutical companies, she developed training modules for a local auditor qualification program that were then adopted by Corporate Quality to be used globally. Plus, developed auditing workshops and GMP training courses for Merck and Co. Inc. Joanne has a B.A. in Biology from Indiana University and a MA in Instructional Systems from Pennsylvania State University.