MMD-103 Understanding of USFDA CFR Title 21 Part 820 Quality System Regulation
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Ampro Solutions Sdn Bhd
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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.
Outline
- 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?
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Ampro believes that the key to a successful and rewarding career is continuous professional development. We have a flexible approach to your training needs with regardless of whatever your requirements, we promise you a high level of service with packages that meet the needs of your business.
As a forward thinking company we deliver training at all levels, thereby supporting your company at every stage of its development. Courses can be delivered onsite at a location of your choice, costs dependent upon location and numbers, or at hotel.
Our Company Values
We are determined in developing new programmes and staying on-point with industry's trend, while maintaining exceptional quality standards.
When we commit to something, we’re totally devoted. Whether it’s our dedication to our clients; or to maintain at the leading edge of training services we offer; we are always dedicated to our task.
Our People
All our staff are highly motivated professionals, experienced and qualified in their own specialist areas, who are committed to works towards common goals.
Our trainers and consultants are quality assure and have been tested on their ability to deliver top-quality programmes. ...
Our Company Values
We are determined in developing new programmes and staying on-point with industry's trend, while maintaining exceptional quality standards.
When we commit to something, we’re totally devoted. Whether it’s our dedication to our clients; or to maintain at the leading edge of training services we offer; we are always dedicated to our task.
Our People
All our staff are highly motivated professionals, experienced and qualified in their own specialist areas, who are committed to works towards common goals.
Our trainers and consultants are quality assure and have been tested on their ability to deliver top-quality programmes. ...
