Implementing Quality Management Systems in Small Companies

Instructor: William G Mclain
Product ID: 700210
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Aug-2007

Training CD / USB Drive

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(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

Many small or virtual companies make one of two common mistakes: their Quality Management System (QMS) is either too cumbersome for their operation or they don’t have a quality management system at all


Quality management issues facing small, startup or "virtual" companies and identifying all required quality management system elements.

This presentation will address the issues facing the small, startup or "virtual" company. Participats will learn how to ensure all required quality management system elements are identified, scaled appropriately to meet their compliance requirements, and effectively implemented. We will also discuss what to to if the inspector or auditor comes for an unexpected visit.

Areas Covered in the Seminar:

  • Quality Management System Basics
  • Identifying which QMS elements are required.
  • Deciding between ISO 13485:2003 and 21 CFR Part 820.
  • How to ensure compliance if you’re not responsible for design or manufacturing.
  • Using supplier agreements for compliance needs.
  • When do I implement my QMS.

Who Will Benefit:

  • Entrepreneurs
  • Small Company CEO’s
  • Research & Development and Engineering
  • Investors

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.

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