FDA Part 820 Basics – Everything you need to know to get your start-up company compliant

Product Id IQW15C6415
Level Basic
Duration 90 Mins
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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.

  • 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

President, CEO, Start-Ups, Executive Management, Quality Assurance Professionals

Denise Wrestler, ASQ CQE, CQA; QA/RA Consultant at CYA Medical Device Consulting, LLC with almost 15 years of experience within FDA-regulated industries including medical device and pharmaceuticals, Ms. Wrestler provides quality, regulatory, and technical expertise to meet individual client needs. Ms. Wrestler agrees with the FDA’s “least burdensome approach” and prides herself on providing options and recommendations for ensuring regulations are met without wasting precious company resources.
Denise Wrestler holds a B.S. in Chemical Engineering with a Minor in Biomedical Engineering from the University of California, Irvine. Additionally, Ms. Wrestler holds ASQ Certifications as a Certified Quality Engineering (CQE) and Certified Quality Auditor (CQA). A contributing author to ASQ’s monthly publication Quality Progress magazine, Ms. Wrestler remains active within the quality and regulatory professional circles to ensure continuing education and awareness within the community. Ms. Wrestler has provided training, workshops, and presentations to small and large audiences alike on topics ranging from QSR, ISO 13485, auditing, and design control to risk management and regulatory readiness and preparation
 

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