How to prep your SMEs for new FDA inspection process

MessageThis Webinar is over
Date Aug 22, 2017
Time 12:00 PM EDT
Cost $185.00
Training and preparing a company’s leadership team on how the new FDA inspection plan will be rigorous for appointed SMEs.
  • Defining the What, Who, and How of a SME.
  • Training and experience expectation to assure SMEs are aligned to the topics they are going to be asked about.
  • Improving SME effectiveness by conducting thorough simulated inspection scenarios.
  • Learn the commonly asked by investigators and answers that are typically found satisfactory.
  • Avoid providing “extra information” that was not required to answer a question.
  • Listening skills – holistically approach.
  • Successfully push back against FDA investigators’ request for documents, if they are not needed.
  • Behavior (responses, body language and tone of voice).


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