In this Medical device training we will discuss methods for documenting and demonstrating control over your suppliers. Emphasis is placed on identifying and implementing these controls, not just auditing to establish compliance.
Medical device manufacturers increasingly rely on outsourcing significant portions of their operations. It is now quite common for much of a quality management system to be outsourced to suppliers. Worldwide regulatory agencies expect the modern medical device manufacturer to demonstrate control over these suppliers. This level of control will vary given the risk of the service provided. In this session we will discuss methods for documenting and demonstrating control over your suppliers. Emphasis is placed on identifying and implementing these controls, not just auditing to establish compliance.
Areas Covered in the seminar:
- Scope and scale of supplier management
- Current regulatory expectations of supplier management
- The use of a Supplier management Plan
- Methods to minimize the need for supplier audits
Who Will Benefit:
- RA/QA Managernt
- Procurement engineers
- Purchasing
- Quality engineering
- Product Development engineering
- Anyone who outsources components, products or services in the medical device industry
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.
