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
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.
Related Technical Documents:
FDA QSR as published in 21 CFR Part 820
FDA QSR Preamble as published in 61 FR 52601-52662
Quality System Regulation (QSR) Management Responsibilities 2010 - 28 Oct 2010, Webinar (8984)
Important
Please, check "Quality System Regulation (QSR) Management Responsibilities" official website for possible changes, before making any traveling arrangements
