FDA Part 820 Basics – Everything you need to know to get your start-up company compliant
Duration : 90 Minutes
Denise Wrestler, ASQ CQE, CQA,
With over 15 years of experience
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 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.
Course Objectives:
• Basic understanding of the regulations listed within 21 CFR Part 820
• Learn how to apply regulations into your company documentation
• Describe the must-have systems required for your QMS
• Develop a checklist plan for ensuring all elements of the regulations are incorporated into your QMS
• Understand the scope of what will be needed to meet FDA requirements
Course Outline:
Topics covered include an overview of 21 CFR Part 820 Subparts:
• General Provisions
• Quality System Requirements
• Design Controls
• Purchasing Controls
• Identification and Traceability
• Production and Process Controls
• Acceptance Activities
• Nonconforming Product
• Corrective and Preventive Action
• Labeling and Packaging Control
• Handling, Storage, Distribution, and Installation
• Records
• Servicing
• Statistical Techniques
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
Regulatory Agency ProfessionalsManagers, Supervisors, Directors, and Vice-Presidents in the areas of:
• R&D
• Manufacturing Engineering
• Design Assurance
• Quality Assurance
• Operations
• Document Control
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
Refund / Cancellation policyGet In Touch
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