ComplianceOnline

Compliance with Canadian Quality Management System Regulatory Requirements

Instructor: Edward Kimmelman
Product ID: 704726
  • Duration: 90 Min

recorded version

$279.00
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

$349.00
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

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

The training program will provide insight into complying with the key QMS requirements for organizations selling medical devices in Canada.

Why Should You Attend:

This webinar will examine the relationship between the Canadian quality management system (QMS) regulations and the requirements contained in ISO 13485:2003. It will also offer insight into handling the most common quality QMS problem areas and discuss the revisions contained in the 2016 version of the standard.

Areas Covered in the Webinar:

  • Relationship between the Canadian quality management system (QMS) regulations and the requirements contained in ISO 13485:2003.
  • Canadian QMS requirements in addition to the requirements contained in the standard (Refer: GD210: ISO 13485:2003 QMS Audits Performed by Health Canada Recognized Registrars).
  • Insight into handling the most common quality QMS problem areas.
  • A discussion of the revisions contained in the 2016 version of the standard.
  • The Canadian medical device quality management system regulatory requirements

Who Will Benefit:

  • Quality Professionals
  • Quality Audit Managers
  • Regulatory Professionals
  • Production Managers
  • Process Owners
  • Project Managers

Instructor Profile:

Edward Kimmelman has been providing consultant services in the areas of regulatory compliance and quality management systems since 1998. During a 35-year career in industry, he has served in engineering, product management, and senior quality systems management positions.

Mr. Kimmelman is a past president of the NCCLS (currently CLSI) and has served as chairman of the HIMA (currently AdvaMed) Standards Section and Science & Technology Section. He recently retired as the convenor of the ISO/TC210, Working Group 1 on quality systems, the administrator of ISO 13485, medical devices – quality management systems – requirements for regulatory purposes. He has coauthored a reference book, The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, 2nd edition, ASQ – Quality Press, 2008.

He received a B.S. degree in mechanical engineering from Cornell University and a J.D. degree from the Seton Hall University School of Law.

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