Quality is always the result of excellent work without compromise.
MMD-103 Understanding of USFDA CFR Title 21 Part 820 Quality System Regulation
Schedule and Hours
ll medical device manufacturers supplying medical devices to the U.S. are required to maintain a quality management system in compliance with the Code of Federal Regulations (CFR) Title 21, otherwise known as 21 CFR 820. The quality management system requirements cover a broad range of areas, including production and process controls, corrective and preventive actions, product development and management.
To understand the requirements of USFDA CFR Title 21 Part 820 Quality System Regulation for effective implementation and compliance.
Introduction on USFDA
Medical devices regulated by USFDA
Subpart A - General Provisions Subpart B - Quality System Requirements Subpart C - Design Controls Subpart D - Document Controls Subpart E - Purchasing Controls Subpart F - Identification and Traceability Subpart G - Production and Process Controls Subpart H - Acceptance Activities Subpart I - Nonconforming Product Subpart J - Corrective and Preventive Action Subpart K - Labeling and Packaging Control Subpart L - Handling, Storage, Distribution, and Installation Subpart M - Records Subpart N - Servicing Subpart O -Statistical Techniques
How to survive an USFDA inspection?
For all personnel who involved in the organizations that are required to conform with USFDA CFR Title 21 Part 820 Quality System Regulation.
This is a 2-days programme. This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.
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