Supplier Management for Medical Device Manufacturers: 2-day In-person Seminar
Dan O'Leary, President at Ombu Enterprises, LLC
San Francisco, CA
Thursday, March 30, 2016 | Friday, March 31, 2016
Thursday, September 22, 2016 | Friday, September 23, 2016
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.
In addition to the discussion material, the course includes multiple exercises, guidance documents, and templates/tools to help you implement an effective program.
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 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
Seminar Fee Includes:
USB with seminar presentation
Hard copy of presentation
$100 Gift Cert for next seminar
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
- Part A – Regulatory Requirements
Part B – Planning for Supplier Management
- Supplier management in FDA QSR & ISO 13485:2003
- EU Medical Device Directive (MDD)
- Supplier Evaluation and Selection
- When suppliers have to register and list with FDA
- Outsourced processes
- Purchasing Data
- Acceptance activities
Part C – Planning for Supplier Selection
- Supplier management as a business process
- The business risk model
- The regulatory risk model
- The medical device risk model
Part D – Potential Suppliers
- Identifying what to procure
- Design control and purchasing data
- Identify risks (business, regulatory, and device)
- Identify controls (business, regulatory, and device)
- Special considerations
- Control numbers
- Conflict Minerals
- Identify potential suppliers
- Evaluative business capability
- Evaluate operational capability
- Using an analysis matrix and a radar chart
- Part E – Supplier Selection
Part F – Implementing Supplier Controls
- Sole source v. single source
- The directed procurement problem
- Selecting the supplier
- The Approved Supplier List
Part G – Monitoring, Measuring, and Evaluation
- Building the final control plan
- Receiving acceptance as a supplier control
- Developing hidden controls
- The supplier quality agreement
Part H – Feedback and Communication
- Standard supplier metrics
- Implementing predictive analysis
- Developing a supplier audit program
- Using the supplier’s QMS certificate
- The backward tracing process audit
- Supplier management as part of Management Review
Part I – Evaluating your program
- Supplier scorecards
- Corrective action requests
- 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
Daniel 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.
Mr. O'Leary is a regular speaker at international conferences including ASQ, ISM, and RAMS. He teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001, FDA QSR, & ISO 13485), and project management. Mr. O'Leary 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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San Francisco, CA (Venue to be announced shortly)
March 30-31, 2016
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September 22-23, 2016
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