FDA Establishment Inspections – What to Expect
Duration : 60 Minutes
Charles H. Paul,
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 Read more
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.
Course Objectives:
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.
Course Outline:
• 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
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
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
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
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