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Course "ISO 13485:2016 Implementation Workshop" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
The medical device industry is in the midst of major change, with the publication of the FDA's UDI Regulation, the first revision to the ISO Quality Management Systems standard in over a decade, and the upcoming changes to the EU's Medical Device Regulation expected to be passed later this year. All of these events have far reaching effects on Quality Management Systems so it is critical to understand what has changed with in 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, roundtable 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 detailed, step-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.
Why you should attend:
Quality management systems are now, more than ever, a requirement rather than an option for sustainable businesses, both for increasing internal efficiency and for creating a competitive advantage. The easiest route for establishing a QMS is to base it on a proven method rather than starting from scratch. Medical device service providers, contract manufacturers, service providers and OEMs will benefit from implementing quality systems based on ISO 13485.
The first part of the seminar will provide you with training on quality systems and the requirements of the revised standard. The second day will focus on developing a plan for implementation and will provide helpful tools you can take back to your organization to kick-start the project.
Areas Covered in the Session:
Who will benefit:
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.
Day 1 Schedule
Anatomy of a Quality Management System
Gap Analysis of ISO 13485: 2003 to ISO 13485: 2016
Application of Risk
Day 2 Schedule
Identification of Documentation Requirements
Monitoring & Measurement of the QMS
Creating a Quality Plan for QMS Updates
Quality & Regulatory Consultant, Qualitas Professional Services, LLC
Lena Cordie has over 20 years of quality and project management experience including:
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:
Location: Salt Lake City, UT Date: May 10th & 11th, 2018 and Time: 9:00 AM to 6:00 PM
Venue: Hilton Garden Inn Salt Lake City Airport 4975 Wiley Post Way, Salt Lake City, Utah, 84116, USA
Price: $1,295.00 (Seminar Fee for One Delegate)
Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*
Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*
Register now and save $200. (Early Bird)
Until March 31, Early Bird Price: $1,295.00 From April 01 to May 08, Regular Price: $1,495.00
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