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How to comply with the FDA’s Quality System Regulation 21CFR Part 820
- What is 21 CFR Part 820 and why is it important?
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Key Provisions of the Regulation – What you need:
1.General provisions of the regulation
2.Management responsibilities
3.Quality Audits
4.Personnel
5.Design Controls
6.Document Controls
7.Purchasing control
8.Identification and traceability
9.Production and process controls
10.Inspection, measuring and test equipment
11.Process validation
12.Acceptance
15.Nonconforming product
16.CAPA
17.Labelling and packaging control
18.Handling, storage, distribution, and installation - Key guidance for complying with the regulation
Overview of the webinar
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:
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:
- Documented in the form of Standard Operating Procedures and Work Instructions
- Integrated into the fabric of how the business executes the activities required to place a medical device in the marketplace and manage that device throughout its lifecycle
- Be managed on a daily basis to ensure the organization’s compliance with the tenants of the regulation
- Be provable when externally audited to verify its effectiveness and compliance with the regulation
Who should attend?
- Associates
- Supervisors
- Managers
- Directors
- Vice Presidents
Why should you attend?
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.
Faculty - Mr.Charles H. Paul
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.