Compliance with Canadian Quality Management System Regulatory Requirements
Instructor:
Edward Kimmelman
Product ID: 704726
- Duration: 90 Min
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
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.
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
