2021 - Purchasing Controls, Supplier Management, and Receiving Acceptance for Medical Devices

Day 01(9:00 AM - 3:30 PM EDT)
09.00 AM: Session Start
Understanding the regulations
FDA QSR and ISO13485
GHTF guidance
FDA Expectations
Authority and Scope
Balance between Supplier Control and Receiving Acceptance
Purchasing Controls Process
Purchasing Data
Planning Purchasing Control and Supplier Management
Supplier Management business process
Business risk
Regulatory risk
Medical Risk
Planning for Supplier Selection
What is being purchased
Design Control and purchasing data
Identify Risks (business, regulatory, medical)
Identify Controls (business, regulatory, medical)
Evaluation of Potential Suppliers
Identify potential suppliers
Evaluate business capability
Evaluate operational capability
Evaluate quality capability
Day 02(9:00 AM - 3:30 PM EDT)
Supplier Selection
Sole vs Single source
Selecting the supplier
Maintaining an ASL (Approved supplier List)
Implementing Supplier Controls
Control Plan
Receiving Inspection
Risk-based audits
Purchasing Data
Quality Agreements
Performance Management
Supplier scorecards
Standard metrics
Supplier Reviews
Maturity Models
Feedback and Communication
Supplier Reviews
Supplier Corrective Action Requests (SCARs)
Lessons Learned
Supplier Audits