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

Training CD

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

Customer Care

Fax: +1-650-963-2556


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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