FDA Audit Best Practices, Do’s, and Don’ts

Learn effective approaches to FDA Audits, & master techniques to interact with inspectors to ensure inspections result in positive outcomes.

Course Overview

The FDA has been increasing its surveillance of regulated industries and planning tougher audits. While it is a given that companies must meet their regulatory requirements, how you handle an audit and interact with FDA inspectors, can mean the difference between a successful and an unsuccessful FDA audit.

This 90-minute webinar will begin by discussing and emphasizing the importance of truthfulness to the process – in performing the job daily, in completing the regulatory documentation, and 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 communication 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, in the moment, adverse findings as they are identified by the inspector so as to not compound the issues and severity of the findings.

Areas Covered

• Importance of truthfulness
• Importance of knowledgeability and confidence
• Tricks used by FDA inspectors to elicit information
• Using subtlety in arguments and when challenging inspectors
• Behaviors during the inspection that influence positive outcomes
• Importance and role of documentation
• Effective communication skills
• Being deceptive
• Opinion versus fact
• Phrases never to say
• Handling adverse findings during the inspection
• Other related topics such as planning the inspection flow, roles to be assigned, areas of emphasis, etc.

Why you should attend?

If you are in any regulated business – pharmaceuticals, medical devices, you will experience an inspection by the U.S. Food and Drug Administration (FDA).

The outcome of FDA inspections can have a 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 greatly influence 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.

Who Should Attend?

• • QA, QC Department
  • Production
  • Engineering
  • R&D
  • Project Managers
  • Regulatory Affairs
  • Compliance
  • Documentation
  • Vice Presidents, Directors, Associate Directors, Managers, and Supervisors in ALL functions

About the Instructor

Charles H. Paul is the President of CHP Consulting Llc – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant for over 25 years and has published numerous white papers on various subjects from project management and technical writing to regulatory compliance in the life sciences. The firm works with domestic and international clients, designing solutions for complex training and documentation issues within the life sciences.

Refund policy

Attendees may cancel up to two working days prior to the course start date and the refund will be processed within two working days.

We will process/provide a refund if the webinar is canceled. Refunds will not be given to participants who do not show up for the webinar. On-demand Recordings can be requested in exchange. Webinar may be canceled due to lack of enrollment or unavoidable factors. Attendees will be notified 24 hours in advance if a cancellation occurs. Substitutions can happen at any time.

If you have any concerns about the content of the webinar and are not satisfied please contact us at care@thecomplyguide.com

Alternatively you can register here!