In this webinar, learn how to effectively respond to warning letters that the FDA will accept. You will also learn how to negotiate with FDA to successfully close warning letters.
The FDA-483 list of Observations following Inspections are increasing with time. FDA is also increasingly turning to warning letters as an instrument for voluntary compliance. State of the art quality systems is an FDA regulatory requirement. Simply having a procedure to follow is no longer enough. The procedure you follow may be inadequate and may, therefore, be not accepted by the FDA.
This webinar will examine the problems FDA is citing in FDA-483s and warning letters pertaining to deficiencies in the quality system. It will also examine inadequate responses and the FDA’s responses to such letters. You will learn how to prepare responses that FDA will accept. Finally, you will learn how to set up quality systems that FDA will accept.Areas Covered in the Webinar:
RAC Principal Consultant, One Way Consultants, LLC, FDA Regulatory Expert
J. Lawrence Stevens, RAC, who has over 20 years of FDA experience encompassing virtually all of the FDA field positions. Also 18 years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. He has personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, was the Industry Representative on the FDA Circulatory Systems panel. Finally, a seasoned educator/speaker with over 250 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public. As a consultant he has presented over 20 webinars on FDA requirements.
Mr. Stevens has met numerous times with FDA as a member of industry, and with industry numerous times as an FDA Official. He is keenly aware of what pitfalls must be avoided, and what FDA expects from the firm with whom they are meeting. Now as a consultant, Mr. Stevens assists firms in meeting FDA requirements and conducting successful FDA meetings.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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