Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
This seminar is broken into two phases. Phase one corresponding to Day 1 will build basic knowledge of the inspection - the who, what, and when. Phase Two will delve into the how of the inspection from the perspectives of the FDA and those being inspected.
One of the key components 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.
Another key component of this seminar 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 seminar 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.
If you are in any regulated business - pharmaceuticals, 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 upon 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 an natural behavior, effective techniques must be learned and mastered if those inspections are to have positive outcomes.