FDA QMS Regulation 21 CFR Part 820

This training provides in-depth insight relative to the content and implementation of the new Quality Management System Regulation including: the purpose, scope and goals of the new regulation; the major provisions and changes associated with the new regulation; the effective date of the new regulation; a discussion of the term “incorporation by reference” (IBR); reference to guidance on the implementation of ISO 13485:2016 within a quality management system; rules for understanding which terms and definitions will be used; FDA’s policy for addressing changes to ancillary regulations, policies, etc. impacted by the new regulation; quality management system regulatory requirements beyond ISO 13485:2016; and, how changes to the CGMPs impact 21 CFR Part 4 Regulation of Combination Products.

By the end of this course, you should be able to:

• Recognize the major provisions of the Quality Management System Regulation.
• Recognize the historical support for the Quality Management System Regulation.
• Identify what organizations will need to comply with the Quality Management System Regulation.
• Recognize terms and definitions specified in the Quality Management System Regulation.
• Recognize FDA’s strategy for addressing policies, procedures, regulations, etc. impacted by the implementation of the QMSR.
• Recognize revisions made to 21 CFR part 4 based on the advent of the Quality Management System Regulation.
• Identify the impact of the Quality Management System Regulation on a CGMP operating system that is compliant with drug and device CGMPs.

This training is essential to anyone involved in transitioning a quality management system to the requirements of the new Quality Management System Regulation; or anyone who works within an impacted quality management system. Learners will be provided a downloadable summary of the training allowing “anytime” access to key points of the training.