FDA Audit Best Practices - Do's and Don'ts

06 Oct 2022
10:00 AM PDT | 01:00 PM EDT
60 Minutes

This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.
A key component of this webinar is the discussion of the tricks and techniques that inspectors use to elicit information. How you react and respond when they occur could impact your results.

Other key communications skills will be presented in the context of the inspection and interpersonal exchanges between inspectors and company associates being questioned.

We will complete the webinar by discussing how to handle, at the moment, adverse findings as they are identified by the inspector so as to not compound the issues and severity of the findings.

WHY SHOULD YOU ATTEND?

If you are in any regulated business - pharmaceuticals, or medical devices, you will 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 on 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 a natural behavior, effective techniques must be learned and mastered if those inspections are to have positive outcomes.

AREA COVERED

  • 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 WILL BENEFIT?

  • Vice Presidents
  • Directors
  • Associate Directors
  • Managers
  • Supervisors in ALL functions will benefit from this organization
  • This is an all-inclusive webinar benefiting all individuals within the organization but particularly those in positions of management and supervision

If you are in any regulated business - pharmaceuticals, or medical devices, you will 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 on 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 a natural behavior, effective techniques must be learned and mastered if those inspections are to have positive outcomes.

  • 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
  • Vice Presidents
  • Directors
  • Associate Directors
  • Managers
  • Supervisors in ALL functions will benefit from this organization
  • This is an all-inclusive webinar benefiting all individuals within the organization but particularly those in positions of management and supervision
Webinar Option
Live + Recorded Session
Live + Transcript
Live + Training CD
Transcript (PDF Transcript of the Training)
Downloadable Recorded Session
Training CD
Group Session Participants + Recorded

Live Session for 10 Participants (For adding extra attendees please contact our Customer Support Team)

Speaker Profile

ins_img 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 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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