This webinar will provide tips and techniques for effectively audiing the risk management process. Topics to be discussed include building the case for auditing the risk management process and provide suggestions for advanced checklist items to assist in the audit.
Risk management according to ISO 14971 is increasingly being implemented in medical device companies. How do we know risk management processes are effective? This webinar will provide tips and techniques for effectively audiing the risk management process. Topics to be discussed include building the case for auditing the risk management process and provide suggestions for advanced checklist items to assist in the audit.
Areas Covered in the seminar:
- Building a case for auditing the Risk Management process
- Brief overview of 14971 requirements
- Items to add to an audit checklist for ISO 14971 audits
Who Will Benefit:
- RA/QA Managernt
- Auditors
- Consultants
- Quality Systems Managers
- Product Development engineering
- Complaint managers
Instructor Profile
William G. Mclain, RAC, B.S.E. is the President and Principal Consultant for Keystone Regulatory Services, LLC. He has over 15 years experience in product development, domestic and international regulatory affairs and risk management, and quality management system design in the medical device industry. He has contributed to the timely development and market introduction of cardiovascular, anesthesiology, gastroenteral, diagnostic and general surgical devices by providing regulatory, quality system and risk management strategy, oversight, and support. An active member of RAPS and ASQ Biomedical Division, Mr. McLain is RAC Certified and holds a BS in Mechanical Engineering from Grove City College.
