Conference & Events
Event Details
Implementing Management Responsibility for Medical Devices - Webinar By GlobalCompliancePanel
The FDA's Quality System Regulation (QSR) prescribes the Quality Management System for a medical device manufacturer who markets in the US.
Date: 06 June 2012 10:00 - 11:15
Event Subject(s):
Biosciences
Education
General
Venue
Online Training
1000 N West Street
Delaware
Suite 1200
Wilmington
19801
United States of America
Find this location using Google Map
Useful link:
Organiser Information
Organiser(s): GlobalCompliancePanel
Contact for Event Information
Name : Online Training
Address:
1000 N West Street
Suite 1200
Wilmington
19801
United States of America
Tel:
800-447-9407
Fax:
302-288-6884
Email:
webinars@globalcompliancepanel.com
Contact Useful link:
http://www.globalcompliancepanel.com
Additional Information
Speaker Information:
Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.
Useful link:
Other information:
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
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone: 800-447-9407
Fax: 302-288-6884
