2022 - Supplier and Contract Manufacturer Management for Medical Device Manufacturers

Comparison of Quality System Regulation (21 CFR 820) to ISO13485:2016
Principles of Purchasing Controls and Supplier Management
The differences between suppliers, contract manufacturers, contract sterilizers, contract designers, and others
Regulatory Expectations
How to “Establish and Maintain” a Quality System with Excellent Standard Operating Procedures
Practical Approaches to an Efficient and Effective Quality Management System
Lessons Learned from Case Studies and Warning Letters
Understand QSR 820.50, 820.80, and ISO13485:2016
Understand GHTF guidance
FDA QSIT approach to inspection
FDA authority over medical device manufacturers and their suppliers
Develop a risk-based approach to supplier audits
Understand the balance between purchasing control and receiving inspection
Corrective and Preventive Action
Good Documentation
Root Cause Analysis
Tool Kit
Inspection Readiness