MMD-103 Understanding of USFDA CFR Title 21 Part 820 Quality System Regulation
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
- Understanding of:
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.
Public Training Schedule:
N/A
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.
Public Training Schedule:
N/A
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