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Validity : 29th Jun'22 to 09th Jul'22
21 CFR Part 820, known as the Quality System Regulation QSR outlines the Current Good Manufacturing Practice (cGMP) regulations that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished medical devices intended for human use.
The purpose of the regulation? It is very simple – to ensure that medical devices are safe and effective. Achieving this safety and effectiveness requirement however is not so simple. It is achieved by implementing what is known as a Quality System consisting of many regulatory requirements as specified in the regulation that must be:
Anyone involved in the Medical Device industry will benefit from this webinar.
Functions: Marketing, Research & Development, Technical Services, Manufacturing, Compliance and Regulatory, logistics/supply chain, Service and Maintenance
Positions: Associates, Supervisors, Managers, Directors, Vice presidents.
Why should you attend this webinar and why is it important to you? If you work within the medical device industry, almost everything that you do every day is somehow touched by this regulation. Ignorance of the sections of this regulation is no excuse for non-compliance. It takes a complete thorough understanding of the regulation to ensure your compliance with it. This webinar will provide that level of understanding and some basic guidance to assure compliance.
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars in a variety of related subjects from documentation development to establishing compliant preventive maintenance systems.