MMD-111 An Overview of 21 CFR 820 & US FDA's Medical Device GMP
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Ampro Solutions Sdn Bhd
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Details
This course introduces the concepts needed to understand, develop, and implement a quality system as outlined in the 21 CFR 820 Quality System Regulations. It provides understanding the legal requirements and US FDA’s expectations
relating to cGMP Quality System Regulation (QSR), as well as the cost of noncompliance.
Participants will be led by an experienced trainer whom, in addition to being a medical device quality systems auditor and product approval reviewer, has nearly 3 decades of assessment, training and quality assurance as
well as management system development experience. Participants will engage in exercises and discussion points, including considerations in harmonizing these requirements and those of the IMDRF with respect to medical devices regulatory compliance as well as
failures encountered by manufacturers during plant inspections.
Outline
- Introduction
- Quality System Regulation
- cGMP Implementation
- The FDA Inspection Process
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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. ...
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