Implementing Quality Management Systems in Small Companies
Instructor:
William G Mclain
Product ID: 700210
- Duration: 60 Min
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
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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