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

Event Details

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

Time: February 14, 2020 from 10am to 1pm
Location: Online
Street: 39658 Mission Boulevard, Fremont, CA 94539, USA.
City/Town: United States
Website or Map: https://www.compliance4all.co…
Phone: +1-800-447-9407
Event Type: online, event
Organized By: Compliance4all
Latest Activity: Dec 10, 2019

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Event Description

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:

  • 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

Who Will Benefit:
  • This is an all-inclusive webinar benefiting all individuals within the organization but particularly those in positions of management and supervision. Vice Presidents, Directors, Associate Directors, Managers and Supervisors in ALL functions will benefit from this organization. Significantly, compliance and regulatory who spearhead the inspections and are responsible for compliance readiness, as well as training that should be building on-going training around this subject should also be included

Speaker Profile
Charles H. Paul is the President of C. H. Paul Consulting, Inc. - a regulatory, manufacturing, training, and technical documentation consulting firm - celebrating its twentieth year in business in 2017. He 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. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.

Event link:

https://www.compliance4all.com/webinar/--502846LIVE?channel=%20medtechiq.ning_2020_SEO

Contact Info

Netzealous LLC,DBA -Compliance4all

Email: support@compliance4All.com

Phone: +1-800-447-9407

Website: https://www.compliance4all.com/

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