ComplianceOnline

Methods for Including Your Risk Management Process In Your Internal Auditing Process

Instructor: William G Mclain
Product ID: 700385
Training Level: Intermediate
  • Duration: 60 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

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.

Why Should You Attend:

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.

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