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 to determine if the inspected company/process complies with FDA guidelines and meets the terms of Federal Food, Drug, and Cosmetic Act. 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.
There are 2 basic types of FDA inspections: Surveillance inspection is routine FDA inspection, whereas the compliance inspection is based on specific objective, such as compliant or other suspected specific problem like unreported Adverse Events (AEs).
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
This is an all-inclusive webinar benefiting all individuals within the Pharmaceutical and Biotech organizations, Medical device manufacturers, Food and Cosmetic manufacturers but particularly those in positions of management and supervision.
- Vice Presidents
- Associate Directors
About the Presenter:
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.
You will receive an email with login information and handouts (presentation slides) 1 day before the live webcast that you can print and share to all participants at your location.
Operating System: Windows any version preferably above Windows Vista & Mac any version above OS X 10.6
Internet Speed: Preferably above 1 MBPS
Headset: Any decent headset and microphone which can be used to talk and hear clearly
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Toll-Free No: 1-302-444-0162
Email: [email protected]
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