By : Compliance Online
Date : 2010
Location : United States US / Palo Alto
This (QSR) Quality System Regulation webinar describes management responsibility by reviewing the Quality System Regulation (QSR) and the reasoning that FDA published. It covers each of the components of management responsibility and provides a list of things
Quality System Regulation webinar, FDA, 21 CFR §820.20, Warning Letter, medical Device training
One of the most common areas for FDA Warning Letters is Management Responsibility. FDA considers this a principal 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.
This webinar examines the requirements for management responsibility using information provided by the FDA. We look at the structure of the regulation in 21 CFR §820.20 and its constituent parts. This section has many defined terms that bear on the understanding. The webinar looks at these terms and explains what they mean. For example, in your company, have you identified “management with executive responsibility”?.
QSR preamble - FDA published draft regulations for comment, and then addresses the comments they received. These comments can help you understand FDA’s intention and what they expect. FDA developed the Quality System Inspection Technique to guide its inspectors. The document has flow charts and narrative that the webinar includes as part of the analysis.
The webinar looks at some warning letters that represent problems the FDA found in management responsibility as they conducted their inspections.These warning letters will help you avoid the same problems.
For each of the topics, the webinar provides a list of things for you to consider. The lists suggest approaches to each component and give some guidance that will make your implementation more successful.
Areas Covered in the Seminar:
Valuable documents that provide understanding.
- Quality System Regulation (QSR), including the definitions
- QSR Preamble
- FDA Paperwork Act submission for QSR (Quality System Regulation)
- FDA’s Quality System Inspection Technique (QSIT) manual
- Warning Letters
Subject Areas covered.
- Quality policy
- Responsibility and authority
- Management Representative
- Management review
- Quality planning
- Quality system procedures
- For each subject area, the webinar includes information from the valuable documents listed above.
Related Technical Documents:
- FDA QSR as published in 21 CFR Part 820
- FDA QSR Preamble as published in 61 FR 52601-52662
- QSR Paperwork Reduction Act Supporting Statement - OMB No. 0910-0073
- Guide to Inspections of Quality Systems
- FDA Warning Letters
Daniel O'Leary, 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.
Organizer : Compliance OnlineComplianceOnline is a Regulatory Affairs Professionals Society(RAPS) RA Professional Development Portal provider. ComplianceOnline is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs ComplianceOnline has agreed to follow RAPS-established operational and educational criteria