Risk Management in the 21st Century

Date : 17th December 2020 to 17th December 2020

Place : United States, Leawood

Website :https://bit.ly/35UNmKG

Contact Person:AbideEdict

Description:

Risk management should extend to all aspects of an FDA regulated firm. This means risk management in the planning phase, the development phase, the manufacturing phase, and the post-market phase.

Risk Management in the 21st Century will be held in Leawood,United States on date 2020-12-17

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Deadline for abstracts/proposals : 17th December 2020

Keynote Speakers : Your instructor will be J. Lawrence Stevens, RAC, who has over 20 years of FDA experience encompassing virtually all of the FDA field positions. Also, eighteen 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 I

Conference Highlights :A good basic guide for risk management is ISO 14971 Risk Management for Medical Devices. The integration of this standard into the FDA Design Control Regulations will not only put you in a state of compliance but more importantly effectively manage the risk of your products Why Should You Attend In today’s litigious society, an effective Risk Management program will protect patient health, and prevent costly lawsuits. In addition, regulatory bodies will closely assess your compliance and an

Venue :Leawood, KS, USA

Check the event website for more details.