The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: February 14, 2020 from 10am to 1pm
Street: 39658 Mission Boulevard, Fremont, CA 94539, USA.
City/Town: United States
Website or Map: https://www.compliance4all.co…
Event Type: online, event
Organized By: Compliance4all
Latest Activity: Dec 10, 2019
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.
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). 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.
Areas Covered in the Session:
Netzealous LLC,DBA -Compliance4all