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This presentation will cover the basics of 21 CFR Part 820, including “human translations” to these often hard-to-read regulations. We will cover the basic systems that are required to be established and maintained for your medical device company and a basic plan of attack for how to get your Quality Management System (QMS) up and running. We will also go over some tips and tricks that will also help ensure regulations are met and review some of the guidance documents provided by the FDA themselves. At the end of the presentation, I will answer any questions or concerns you may have regarding 21 CFR Part 820
Your approval or clearance letter for your new medical device states that you must meet the quality system regulations required per 21 CFR Part 820 of the FDA’s Code of Federal Regulations – but what does that mean? If you are new to the medical device industry, understanding these regulations and translating them into your business model can be confusing and challenging.
This presentation will provide you with a basic understanding of the regulations listed within 21 CFR Part 820, teach you how to apply regulations into your company documentation, describe the must-have systems required for your QMS, help you develop a checklist plan for ensuring all elements of the regulations are incorporated into your QMS, and better understand the scope of what will be needed to meet FDA requirements.
President, CEO, Start-Ups, Executive Management, Quality Assurance Professionals