Supplier Management for Medical Device Manufacturers: 2-day In-person Seminar
Dan O'Leary, President at Ombu Enterprises, LLC
| Thursday, April 24, 2014 | Friday, April 25, 2014
Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide components to the device manufacturer, which means that they are critical to performance and delivery. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment.
- How well do you understand the requirements for supplier management?
- Could you pass a regulatory audit or inspection without any issues?
This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program.
This two-day hands-on course provides a clear understanding of the underlying principles of supplier management. The course uses exercises to solidify understanding. In addition, the course uses FDA Warning Letters to illustrate the points and help you learn from others. As part of the practical implementation, the course includes receiving acceptance activities, outsourced processes, process validation at the supplier’s location, supplier auditing techniques, and supplier issues in management review.
The course uses the Global Harmonization Task Force (GHTF) framework, but expands it to cover other issues and techniques important in effective implementation.
Upon course completion, participants will:
- Understand FDA QSR and ISO 13485 requirements for supplier management
- Understand the FDA’s multi-tier supplier classification system
- Understand when suppliers have to register and list with the FDA
- Use an analysis matrix and radar chart to compare suppliers
- Explain the link between design control and purchasing data
- Develop an overall supplier management plan
- Understand the how to develop and implement supplier controls
- Create receiving inspection criteria and apply them as part of supplier controls
- Create supplier measurement and monitoring systems
- Create a system for supplier business risk
- Create a system for supplier regulatory risk
- Create a risk based system for supplier audits
- Develop a supplier audit using the backward trace process approach
Who will Benefit:
- Quality Managers
- Supply Chain Managers
- Quality Engineers
- Supplier Quality Engineers
- Purchasing Professionals
- Regulatory Specialists
- Production and Process Engineers
- Design and Development Engineers
- Verification and Validation Specialists
|Day One (8:30 AM – 4:30 PM)
||Day Two (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
- Introduction/Fundamentals – Regulatory Requirements
Planning the Supplier Management Program
- Supplier management in FDA QSR
- Supplier management in ISO 13485
- Supplier management in the EU’s Medical Device Directive
- Acceptance activities
- Outsourced processes
- When suppliers have to register and list with FDA
Planning Supplier Selection
- Supplier management as a business process
- Developing a business risk model for supplier management
- Developing a regulatory risk model for supplier management
- Case Study and exercise on risk models
- Identifying what to procure
- Role of design control, design transfer, and purchasing data
- Identify risks (business and regulatory)
- Identify controls (business and regulatory)
- Case Study and exercise on developing purchasing data
- Identify potential suppliers
- Evaluate operational capability
- Evaluate business capability
- Use an analysis matrix and radar chart to compare suppliers
- Case Study and exercise on comparative supplier analysis
- Supplier Selection
Implementing Supplier Controls
- Sole source v. single source
- The directed procurement problem
- Evaluating the supplier, final step
- The Approved Supplier List
- Case Study and exercise on sole source and single source suppliers
Monitoring, Measuring, and Evaluation
- Building the final control plan
- Purchase orders and contracts
- The supplier quality agreement
- Developing “hidden controls”
- Receiving acceptance as a supplier control
- Case Study and exercise on the final control plan
Feedback and Communication
- Standard supplier metrics
- Implementing predictive analysis
- Developing a risk based supplier audit program
- Using the supplier’s QMS certificate
- The backward tracing process audit
- Removing a supplier from the Approved Supplier List
- Supplier management as part of Management Review
- Case Study and exercise on the final control plan
Evaluating your Program
- Supplier scorecards
- Corrective action requests
- Supplier meetings
- Case Study and exercise on supplier scorecards
- Supplier management maturity models
- FDA’s QSIT
- GHTF guidance on auditing supplier control
- Case Study and exercise on maturity models
Meet Your Instructor
President at Ombu Enterprises, LLC
Dan O'Leary has more than 30 years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a master’s degree in Mathematics, focusing on logic and number theory. His professional experience relates to quality, regulatory, reliability, and operations management.
Dan is a regular speaker at international conferences including ASQ, ISM, and RAMS. Dan teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001, FDA QSR, & ISO 13485), and project management. Dan is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; he holds an APICS certification in Resource Management.
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Tampa, FL (Venue to be announced shortly)
April 24-25, 2014
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