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

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

Any regulated business, such as pharmaceuticals or medical devices, is expected to face an inspection by the FDA. The Food, Drug and Cosmetic Act mandates that a registered domestic drug establishment should be inspected by the FDA at least once in two years. These inspections could occur more frequently, depending upon the inspection type and the circumstance.

Regardless of how right a business thinks it is with its practices, it should be prepared for consequences that arise from an FDA inspection. The way its employees behave with the FDA inspectors can have an impact on the results reported. The method of Interacting with inspectors is an effective technique that must be learned and mastered for the inspections to carry positive outcomes.

A sixty-minute webinar from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, will show exactly what needs to be done during an FDA inspection to beget the best results from it.

For this valuable training, Compliance4All brings the President of C. H. Paul Consulting, Inc., a regulatory, manufacturing, training, and technical documentation consulting firm, as the expert. Please visit Compliance4all to register and gain valuable insights into this crucial learning.

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Charles will begin this session by giving an understanding of and emphasizing the importance of truthfulness. He will underscore the importance of truthfulness from the standpoints of performing the job on a daily basis, truthfulness in completing the regulatory documentation that is such a core part of our careers in the regulatory industry, and finally, truthfulness when interacting with the FDA inspectors.

He will next impart an understanding of another key component of this webinar, which is the types of tricks and techniques that inspectors use to elicit information. The way in which employees react and respond to these techniques has an impact on the results.

He will then move on to the communications skills needed in the context of the inspection and interpersonal exchanges between inspectors and company associates being questioned.

The expert will round up the session by showing the ways of handling adverse findings when FDA inspectors find them, in a manner that does not go on to exacerbate the issues and severity of the findings.

Charles will cover the following areas at this webinar:

• 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

Those in positions of management and supervision, such as Vice Presidents, Directors, Associate Directors, Managers and Supervisors in all functions, those in compliance and regulatory roles who spearhead the inspections and are responsible for compliance readiness, will find this course useful.

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About the expert: Paul’s company, C. H. Paul Consulting, Inc., is a regulatory, manufacturing, training, and technical documentation consulting firm. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.

Paul has been a regulatory and management consultant and an Instructional Technologist for 30 years, and has published numerous white papers on various regulatory and training subjects.

Apart from holding senior positions in consulting and in corporate training development, he has also worked for several years in government contracting, where he has managed the development of significant Army-wide training development contracts. His work has impacted virtually all of the active Army and changed the training paradigm throughout the military.

Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations.