MMD-111 An Overview of 21 CFR 820 & US FDA's Medical Device GMP
Overview
Course Objectives
Course Content
For Whom
Schedule and Hours
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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.
This course will provide participants with an overview of the FDA and intention of the 21 CFR Part 820, current requirements of the 21 CFR Part 820, working knowledge in application to their organization as well as ability to prepare and host the FDA inspection.
Background of 21 CFR Part 820
Quality System Regulation
Best Practices to Implement each cGMP QSR
How to get ready for FDA Plant Inspections
Introduction
Quality System Regulation
cGMP Implementation
The FDA Inspection Process
Anyone involved in defining, planning, or implementing a 21 CFR 820-based cGMP QSR
Management representatives
Implementation team members
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.
We are HRD Corp (Human Resource Development Corporation) Registered Training Provider. All of our training modules are claimable under HRD Corp.