2012 - Implementing Management Responsibility for Medical Devices -

Overview: The FDA's Quality System Regulation (QSR) prescribes the Quality Management System for a medical device manufacturer who markets in the US.
ISO 13485 covers the rest of the world. The webinar describes management responsibility by reviewing the regulations and the reasoning that FDA published. Management responsibility, in QSR, has five major components: Quality Policy, Organization, Management Review, Quality Planning, and Quality System Procedures. The webinar covers each of these topics and provides a list of things you should consider in your implementation.
Why should you attend: One of the most common areas for FDA Warning Letters is Management Responsibility. FDA considers this a principle subsystem and is where they start inspections. Ensuring that you understand what they expect and how to implement it is a valuable approach to preventing problems. More than that, however, a company can achieve tremendous value by setting up the FDA system. Effective management reviews, for example, can help your company identify opportunities for improvement, resolve issues, and make better products at lower cost. Quality plans and document structure outlines can help ensure you have covered all the requirements, i.e., no gaps, but that you haven’t duplicated effort or created redundant procedures.
Areas Covered in the Session:
Valuable documents that provide understanding
Quality System Regulation (QSR), including the definitions
QSR Preamble
ISO 13485:2003
FDA's Quality System Inspection Technique (QSIT) manual
Warning Letters
Subject Areas covered
Quality policy
Organization
Responsibility and authority
Resources
Management Representative
Management review
Quality planning
Quality system procedures
For each subject area, the webinar includes information from the valuable documents listed above
Who will benefit:
Device Company Executives
Device company Managers
Quality Managers
Regulatory Affairs Managers
Risk Managers
Management Representatives
Production Managers
Design Engineering Managers
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
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