Risk Management in the 21st Century
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 effective Risk Management program will help avoid regulatory problems.
Objectives of the Presentation
- Obtain an understanding of the Standard and Accompanying Guidance
- Understand how Good Design Controls reduce product risks
- Understand why design controls are not sufficient alone and that Risk Management Is still needed even with good Design Controls
- Understand why Risk Management & Design Controls Must Be Linked
- Learn how to measure the effectiveness of your Risk Management efforts.
Areas Covered in the Session
- ISO 14971, Risk management for medical devices.
- 21 CFR Part 820.30, FDA design controls
- How to create an effective risk management SOP
- How to document risk management efforts.
Who Will Benefit
- VP
- Directors or Managers of R&D
- Directors or managers of RA/QA
- Internal Quality Auditor
- Regulatory Consultants
To Register (or) for more details please click on this below link:
Email: support@abideedict.com
Toll Free No:1-844-511-8858
Tel: +1-913-871-1466
Speaker and Presenter Information
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 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. He regularly serves as an Expert Witness in cases involving FDA regulation of medical devices.
Relevant Government Agencies
Dept of Education
This event has no exhibitor/sponsor opportunities
When
Thu, Dec 17, 2020, 1:00pm - 2:00pm
ET
Website
Click here to visit event website
Organizer
AbideEdict
