Healthcare 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:

Quality Policy

Organization

Management Review

Quality Planning

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 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.

Contact Detail:

Compliance4All DBA NetZealous,

Phone: +1-800-447-9407

Email: support@compliance4All.com

http://www.compliance4all.com/

Event Link : http://www.compliance4all.com/control/w_product/~product_id=501045LIVE?channel=mailer&camp=webinar&AdGroup=sciencedz_Nov_2016_SEO

Twitter Follow us – https://twitter.com/compliance4all

Facebook Like us – https://www.facebook.com/Compliance4all

LinkedIn Like us – https://www.linkedin.com/company/compliance4all