FDA Part 820 Basics - Everything you need to know to get your start-up Company Compliance

Instructor: Denise Wrestler
Product ID: 706006
Training Level: Basic
  • Duration: 90 Min
In this webinar attendees will learn the basic understanding of the regulations listed within 21 CFR Part 820, how to apply regulations into your company documentation, describe the must-have systems required for your QMS, Also attendees will learn how to 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.
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Why Should You Attend:

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.

Areas Covered in the Webinar:

  • 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

Who Will Benefit:

  • President
  • CEO
  • Start-ups
  • Executive management
  • Quality assurance professionals
Instructor Profile:
Denise Wrestler

Denise Wrestler
QA and RA Consultant , CYA Medical Device Consulting LLC

With over 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) as well as lead auditor certification for ISO 13485. 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.

CYA Medical Device Consulting provides services to individual clients as well as companies ranging from 10 to 1,000 employees.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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