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FDA Establishment Inspections - What to Expect? - Webinar

  • ID: 4899553
  • Webinar
  • May 2019
  • Region: Global
  • 90 Minutes
  • Compliance Online
Why Should You Attend:

The Food, Drug, and Cosmetic (FD&C) Act gives FDA the authority to conduct inspections at drug and medical device manufacturing facilities as well as other regulated industries. Those companies manufacturing drugs and higher risk medical devices, are prime candidates for inspections. Facilities having historical significant violations, are also FDA inspected.

If you are in any regulated business you will at some time experience an inspection by the U.S. Food and Drug Administration (FDA). According to the Food, Drug and Cosmetic Act, “Registered domestic drug establishments shall be inspected by the FDA at least once every two years.” Depending upon the inspection type and the circumstance, inspections may occur more frequently. The outcome of those inspections can have a grave significant impact upon your business even if you and your colleagues have done everything “right.” How you and others behave and interact with FDA inspectors can have an impact on the results reported. Interacting with inspectors is not an natural behavior, effective techniques must be learned and mastered if those inspections are to have positive outcomes.

Areas Covered in the Webinar:

The inspection process – what to expect
Importance of truthfulness
Importance of knowledgeability and confidence
FDA Tricks to elicit information
Arguing and challenging
Behavior during the inspection
Importance and role of documentation
Effective communication skills
Being deceptive
Opinion versus fact
Phrases never to say
Handling adverse findings during the inspection
Note: Product cover images may vary from those shown
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars in a variety of related subjects from documentation development to establishing compliant preventive maintenance systems. The firm works globally completing projects throughout the EU, UK, South America, and Asia.
Note: Product cover images may vary from those shown