Скачать или смотреть FDA Best Audit Practices - Do's and Don'ts

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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.

Areas Covered:-

Importance of truthfulness
Importance of knowledge 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.

The FDA has been increasing its surveillance of regulated industries. While it is a given that companies must meet their regulatory requirements, how company staff handle an audit and interact with FDA inspectors can mean the difference between a successful and an unsuccessful FDA audit. The cost of an ineffective interaction can be staggering.

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 circumstances, inspections may occur more frequently. The outcome of those 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 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.

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