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 you should consider in your implementation.
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
For More Information: