The medical device industry is in the midst of major change, with the publication of the FDA's UDI Regulation, the first revision in over a decade to the ISO 13485 Quality Management Systems standard, and the changes to the EU's Medical Device Regulation that was just approved in April 2017. All of these events have far-reaching effects on Quality Management Systems so it is critical to understand what has changed within ISO 13485:2016 in order to create a comprehensive quality plan for your organization to ensure continued compliance and certification.
This interactive session will include lectures, round table discussions and activities all aimed at understanding key strategies and identifying specific actions to effectively improve Quality Management System Compliance. The program will also include detailedstep-by-step guidance on how to develop, implement and maintain strategies in order to achieve a specific goal. Participants will want to come to the sessions with a thorough knowledge of improved company strategies and a willingness to discuss aspects of it in a confidential learning environment.
Who will Benefit
- Gain an understanding of the relationship between standards and quality management systems
- Understand the basic principles of a quality management system
- Incorporate the Plan-Do-Check-Act approach
- Identify the critical elements of a quality system
- Create a documentation structure that is consistent with the system requirements
- Assess and apply risk throughout the quality system
- Compare the requirements of ISO 13485 to the FDA QSR
- Understand the differences between ISO 9001, ISO 13485:2003 and ISO 13485:2016
- Identify the QMS requirements of the EU Medical Device Regulation that are not included in ISO 13485: 2016
- Establish a plan for implementing the revised requirements of ISO 13485:2016
Executives, Directors, Senior Managers and Functional Managers from the Medical Device Industry with responsibilities in the following areas. We encourage the participation of more than one person from each company to facilitate the creation and implementation of your action plans.
- Quality Management Systems
- Quality Assurance
- Regulatory Affairs
- Risk Management
- Project Manager
- Design Controls
- Standards & Regulations
Lena Cordie - Owner/Principal 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 labeling 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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Online Compliance Panel will issue an electronic event pass to each registered candidate once the registration is confirmed. Please bring the pass to the venue of the event.
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