Overview of Changes in ISO 13485: 2016
Instructor:
Lena Cordie Bancroft
Product ID: 704756
- Duration: 60 Min
Why Should You Attend:
With the much anticipated release of ISO 13485: 2016, medical device manufacturers are faced with another major regulatory change to their quality management systems. The revisions in this new version range from relatively minor to significant shifts in application.
In this webinar, learn about the changes made in the new version, the impact these changes will have on the industry, and the timeline for implementing the new requirements. After attending this overview, attendees will be one step closer to creating a comprehensive quality plan for your organization’s update.
Learning Objectives:
- Gain an understanding of the new risk-based approach
- Get clarification on management review requirements
- Understand how to apply additional supplier controls
- Learn how improvement and corrective action clauses are strengthened
Areas Covered in the Webinar:
- Changes from ISO 13485: 2003 to ISO 13485: 2016
- Intent of the revised standard
- Transition period for implementing the changes
Who Will Benefit:
- Quality System Associates and Managers
- Regulatory Affairs Associates and Managers
- Supply Chain Professionals
Lena Cordie
Quality & Regulatory Consultant , Qualitas Professional Services, LLC
Lena Cordie has over 20 years of quality and project management experience including 10 years in project management at Target Financial Services and 11 years as director of operations at Key Surgical, a medical device company focused on sterile processing, personal protection, and OR products. In this position she was responsible for overseeing all quality and regulatory functions, production, product procurement, and order fulfillment.
As a consultant at Qualitas Professional Services, LLC, Ms. Cordie now focuses on helping companies implement quality management systems, UDI solutions for labelling and FDA GUDID submissions, and providing validation, documentation and project management resources to global medical device companies.
She is an active member of AAMI (Association for the Advancement of Medical Instrumentation) – serves as a voting member of many sterilization standards committees and co-chairs the terminology committee; ISO (International Organization for Standardization) – serves as a US representative and participates in ISO/TC 198 (ISO 17664 & ISO 11139) and ISO/TC 210 (ISO 13485 & ISO 15223) working groups; and RAPS (Regulatory Affairs Professionals Society) – serving as chairperson of the RAPS Twin Cities Chapter.
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