In-Person EventMay 10 - 11, 2018Salt Lake City, Utah, USA
Speakers
OVERVIEW
Implementation Workshop is organized by GlobalCompliancePanel and will be held during May 10 - 11, 2018 at Hilton Garden Inn Salt Lake City Airport, Salt Lake City, Utah, United States of America. This CME Conference has been approved for a maximum of 12 credits.
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.
• Quality associates
• Quality managers
• Document Control coordinators
• Project Managers
• Regulatory Affairs professionals
• Middle management in regulated industries
• Independent service organizations
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.
Conference Overview:
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 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, 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.