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Recorded Webinar
Effective Responses to FDA Warning Letters on Quality Systems
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
FDA has increasingly turned to Warning Letters as a tool for voluntary compliance. Unfortunately the types of issues FDA is including in Warning Letters makes mere compliance not sufficient, but rather state of the art quality systems. It is no longer sufficient to have a procedure and follow it. FDA may consider the procedure inadequate and evidence you follow the procedure may not be acceptable to FDA as you may have not done it up to the FDA requirements.
In this webinar we will discuss the kinds of issues FDA is citing in Warning Letters relating to quality system deficiencies. We will discuss inadequate responses and the FDA consequences for such. We will discuss how to prepare a response FDA will consider acceptable.
Finally we will discuss how to establish quality systems that will be acceptable to FDA and avoid Warning Letters.
Your instructor has held almost every field position within FDA during his 18 year career with FDA, Investigator, Supervisory Investigator, Compliance Officer, Director of Import Operations, Acting Director of Compliance and Acting District Director. He also has over 18 years experience in the Medical Device industry rising from an RA Manager to being a Vice President of RA/QA/Clinical for major class 3 device manufacturers.
Course Objectives:
- Become familiar with issues that are in FDA Warning Letters
- Know what kinds of response will not be acceptable to FDA
- Know how to effective respond to a Warning Letter
- Know what kinds of company actions can avoid Warning Letters
- Know how to negotiate with FDA to effectively close Warning Letters
Who should attend
VP’s, Directors, and Managers of Regulatory Affairs, Quality Assurance. Internal GMP Auditors, Consultants who assist firms with Warning Letter remediation.
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