So, we perform Management Reviews because FDA regulations require it? In fact, if you are performing management reviews only to satisfy FDA, you may be complying but you are probably wasting your time. Effective management reviews should have tangible value to the senior executives performing the review. In this online training, we will review how to perform effective management reviews that will assist in the effective management of the company.
Effective Management Reviews will not only meet the regulatory requirement but also serve as valuable tool for senior management. Those in the medical device industry are aware that management reviews are required by FDA regulation, specifically in the Quality System Regulation, 21 CFR Part 820. The specific regulation is Part 820.20 (c). The regulation is not very specific on how to set up an effective management review procedure. Merely to hold a management review to please the regulators will in most cases be a waste of time. But by establishing effective management reviews, they will be a valuable tool to allow Senior Management to be more effective.
In this webinar, we will discuss all the essential elements for effective management review. We will discuss key requirements for the procedure, and how to schedule management reviews. We will also discuss how to measure the effectiveness of your management review program.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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