21 CFR Part 820 and ISO 13485:2003 - Best Practices in Quality Management System Basics

Instructor: William G Mclain
Product ID: 700211
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Aug-2007

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

Basic requirements and best practices of quality management system for non-Regulatory and Quality Assurance experts in the medical devices industry.


This seminar will focus on helping the non-RA/QA expert understand the basic requirements and best practices of a QMS.

For those starting in the medical device industry, understanding how a quality management system works, how it’s intended to fit together can be a mystery. This seminar will focus on helping the non-RA/QA expert understand the basic requirements and best practices of a QMS. We’ll discuss how the elements work together and how the QMS can be used to work for your business, not against it.

Areas Covered in the Seminar:

  • Quality Management System Basics
  • Knowing which QMS elements are important to my operation.
  • Working effectively with vendors.
  • Piecing together complaints, manufacturing issues, vendor issues with CAPA.
  • How does risk management fit into the QMS?
  • Deciding between ISO 13485:2003 and 21 CFR Part 820.

Who Will Benefit:

  • Entrepreneurs
  • Small Company CEO’s
  • Research & Development and Engineering
  • Investors
  • Quality Systems Management
  • Documentation Management
  • VPs, Directors and Heads of: Quality Assurance, Compliance, Validation & Regulatory Affairs

Instructor Profile:

William G. Mclain, RAC, B.S.E. is the President and Principal Consultant for Keystone Regulatory Services, LLC. He has over 15 years experience in product development, domestic and international regulatory affairs and risk management, and quality management system design in the medical device industry. He has contributed to the timely development and market introduction of cardiovascular, anesthesiology, gastroenteral, diagnostic and general surgical devices by providing regulatory, quality system and risk management strategy, oversight, and support. An active member of RAPS and ASQ Biomedical Division, Mr. McLain is RAC Certified and holds a BS in Mechanical Engineering from Grove City College.

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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.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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