The role of Quality leaders, general managers, and executives includes "Management Responsibility". It includes:
Quality System Procedures
Why should you Attend:
Recalls, 483s, warning letters and consent decrees are just the beginning. Other FDA actions can include seizure, injunction, and civil money penalties. And the Park Doctrine means that executives can even be sentenced to prison. Strict liability means that a prosecutor does not need to prove criminal intent. Media exposure, customer injury and death, and class action lawsuits can result in disaster for your business.
Areas Covered in the Session:
Basics of the Quality System Regulation (QSR) requirements
What "Management Responsibility" means to the FDA
Park Doctrine and FDCA (Food, Drug, and Cosmetic Act) Violations
The ten commandments for creating a culture of quality in your organization
How to use management review to ensure you have a suitable quality system
Case studies and examples
Risk-based decision making
Creating quality plans and strategies
Who Will Benefit:
Quality Managers, Directors, VPs
Quality Systems Specialists
Process Owners wishing to monitor and improve their processes
IT Personnel supporting Quality, Compliance, Clinical, Regulatory Organizations
General Managers wanting to reduce Quality and Compliance Risk
Susanne Manz MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance.
Compliance4All DBA NetZealous,
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Don't wait to register for the Training by Compliance4all on Quality and Compliance for Medical Devices. You'll meet influential people and maximize your opportunities for success. Start now by accessing the information below.
|Conference/Event Dates:||11/29/2016 - 11/29/2016|
|Conference/Event Hours:||90 Minutes|
|Other Industries:||Manufacturing, Medical|
|Cost to Attend:||One Dial-in One Attendee Price: US$150.00|
|Number of Exhibitors:||1|
|Booth Size||Booth Cost||Available Amenities|
|Marketing Vehicles Allowed:||n/a|
|Other Booth Sizes Available: n/a|
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