ComplianceOnline

Discussion of Revisions Contained in ISO 13485:2016

Instructor: Edward Kimmelman
Product ID: 704506
  • Duration: 90 Min

recorded version

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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Mar-2016

Training CD

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Read Frequently Asked Questions

The training program will prepare attendees to better understand the revisions to this standard as they read its requirements in detail. For those organizations that have a QMS that's compliant with ISO 13485:2003, you will benefit from this program as it will help you assess your preparations.

Why Should You Attend:

This webinar will focus on changes to the QMS requirements contained in the latest version of the ISO 13485 standard. ISO 13485:2003 has served for many years as the international standard for QMS for the medical device industry. Many of the individual and regional medical device QMS requirements are based on the requirements contained in this standard. ISO Technical Committee 210, Working Group 1, has been working for the past three years to revise this standard. The revisions address new technological developments currently being employed by medical device companies (e.g., use of risk-based decision making within their quality management systems and the use of electronic IT systems). The revisions also reflect the current compliance expectations of the US FDA and other national and regional QMS regulations.

Areas Covered in the Webinar:

  • Making risk-based decisions related to issues outside of product realization (e.g., personnel competency, complaint handling, corrective actions, preventive actions)
  • Focusing management review on the suitability, adequacy, and effectiveness of your QMS
  • Validation of all kinds of software related to your QMS
  • Handling corrective actions without undue delay

Who Will Benefit:

  • Quality Managers
  • Quality Professionals
  • HR Managers
  • Regulatory Professionals
  • Production Managers
  • Risk Managers
  • Project Managers
  • Production Supervisors
  • Process Owners
  • Quality Audit Managers
  • Company personnel who manage or operate directly within their organization’s quality management system

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.

Topic Background:

Medical device regulations require that manufacturers have enough people to perform all of the required tasks and that everybody is competent to do their job. The regulations also require the four dimensions of competency: education, training, background or skill, and experience. As a result, ISO 13485 requires an effectiveness evaluation of training or other actions to satisfy competency requirements.

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Refund Policy

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.

If you have any concern about the content of the webinar and not satisfied 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 customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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