FDA Establishment Inspections – What to Expect

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.

Why You Should Attend: 

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 Session :

• 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

Who Should Attend:

This is an all-inclusive webinar benefiting all individuals within the organization but particularly those in positions of management and supervision from every department.

• Vice Presidents
• Directors
• Associate Directors
• Managers and Supervisors
• Compliance and Regulatory Professionals who spearhead the inspections and are responsible for compliance readiness
• Training Departments

Course Director: CHARLES H. PAUL ‎

Charles Paul is an instructional designer and management consultant with over 30 years’ experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product OTC industries.