Training by Compliance4all on Quality and Compliance for Medical Devices

OVERVIEW:
The role of Quality leaders, general managers, and executives includes "Management Responsibility". It includes:

1. Quality Policy
2. Organization
3. Management Review
4. Quality Planning
5. Quality System Procedures

The FDA expects your compliance, your business depends on it, and your customers demand safe and effective medical devices. This 90-minute webinar will set you on the correct path to establishing an effective and efficient quality system. We'll explore the regulations, what you need to learn in every management review, key questions and check lists, and what you need to do. We'll discuss how you can create a culture of quality and "set the tone at the top".

Product Id : 501045
Instructor : Susanne Manz

Tuesday, November 29, 2016 | 10:00 AM PDT | 01:00 PM EDT | Duration: 90 Minutes

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. Every executive, general manager, quality leader, and management representative in a medical device company needs to understand these consequences. In this 90-minute webinar, you'll learn how to prevent them.

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 Leaders
• Quality Managers, Directors, VPs
• Management Representatives
• Compliance Leaders
• Quality Systems Specialists
• Internal Auditors
• CAPA 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
• Executives

SPEAKER PROFILE
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. Susanne has a BS in Biomedical Engineering and an MBA from the University of NM.

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