FDA Audit Best Practices - Do's and Don'ts
Learn how to interact with FDA inspectors truthfully and confidently, recognize the techniques they use to draw out information, and handle adverse findings during the inspection.
Speaker
Charles H. Paul
Regulatory and training consultant · C. H. Paul Consulting, Inc. · President, C. H. Paul Consulting
Overview
How your team behaves during an FDA inspection can shape the results as much as your records do. This 60-minute FDA audit best practices webinar starts with truthfulness: in daily work, in the regulatory documentation you complete, and in every exchange with FDA inspectors.
A central part of the session looks at the tricks and techniques inspectors use to draw out information, and how your reactions can affect the outcome. You'll also cover the communication skills that matter during an inspection, including keeping opinion separate from fact and the phrases you should never say.
The webinar closes with how to handle adverse findings in the moment, as the inspector raises them, so you don't make the issue worse or more serious.
Why attend: Any pharmaceutical or medical device business will face FDA inspections. Under the Food, Drug, and Cosmetic Act, registered domestic drug establishments must be inspected at least once every two years, and some inspections happen more often. The outcome can seriously affect your business, even when you have done everything right. Dealing with inspectors doesn't come naturally, so the techniques have to be learned. The session suits vice presidents, directors, managers and supervisors in every function, and anyone else who may speak with an inspector.
What’s covered
- Why truthfulness matters
- Why knowledge and confidence matter
- Tricks FDA inspectors use to elicit information
- Arguing with and challenging the inspector
- Behavior during the inspection
- The importance and role of documentation
- Effective communication skills
- The risks of being deceptive
- Opinion versus fact
- Phrases never to say
- Handling adverse findings during the inspection
Who should attend
What you get
About the speaker
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 on a variety of related subjects from documentation development to establishing compliant preventive maintenance systems.
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