Supplier Management for Medical Device Manufacturers: 2-day In-person Seminar
Dan O'Leary, President at Ombu Enterprises, LLC
Thursday, September 22, 2016 | Friday, September 23, 2016
San Francisco, CA
Thursday, November 10, 2016 | Friday, November 11, 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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Philadelphia, PA(Venue to be announced shortly)
September 22-23, 2016
San Francisco, CA(Venue to be announced shortly)
November 10-11, 2016
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Philadelphia, PA, Local Attractions
San Francisco, CA, Local Attractions
Philadelphia Museum of Art
The Philadelphia Museum of Art sits majestically on a rise at the end of the Benjamin Franklin Parkway. The vast collections of this temple of art make it the third-largest art museum in the country, and an absolute must-see on the city's cultural circuit.
Among its impressive holdings in Renaissance, American, Impressionist and Modern art, some standouts include a great Rogier van der Weyden altarpiece, a large Bathers by Cezanne, a room devoted to Philadelphia's own Thomas Eakins, and Marcel Duchamp's notorious mixed-media Bride Stripped Bare by her Bachelors (The Large Glass), exactly as the dada master installed it.
Valley Forge National Historical Park
With more than 3,600 acres of rolling hills and well-worn trails, Valley Forge is now a magnet for runners, bicyclists and picnickers as well as history buffs.
The vast expanse of open space links the Schuylkill River Trail to the Horse Shoe Trail, turning the park into a major hub in a 75-mile system linking Philadelphia to the Appalachian Trail.
The Liberty Bell Center
The Liberty Bell has a new home, and it is as powerful and dramatic as the Bell itself. Throughout the expansive, light-filled Center, larger-than-life historic documents and graphic images explore the facts and the myths surrounding the Bell.
National Constitution Center
The 160,000-square-foot National Constitution Center explores and explains this amazing document through high-tech exhibits, artifacts, and interactive displays. The Kimmel Theater, a 350-seat star-shaped theater, features “Freedom Rising,” a multimedia production combining film, a live actor and video projection on a 360° screen to tell the stirring story of “We the people.”
The Franklin Institute
An innovator in designing hands-on exhibits before “interactive” became a buzzword, The Franklin Institute is as clever as its namesake. Its eminently touchable attractions explore science in disciplines ranging from sports to space.
Highlights include The Sports Challenge, which uses virtual-reality technology to illustrate the physics of sports; The Train Factory's climb-aboard steam engine; Space Command's simulated earth-orbit research station; a fully equipped weather station; and exhibits on electricity.
Think Escape Party Bus
San Francisco Bay Area
Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Planning the perfect night on the town is easy with Think Escape's fleet of luxury buses and extended vehicles, each with different amenities for socializing and transport. Think Escape's Bay Area party bus rentals include free entry into selected exclusive nightclubs, professional hostess and chauffer, in-vehicle coolers stocked with amenities for a perfect night of partying.
Alcatraz Lunch Cruise
The Alcatraz Lunch Cruise is a luxurious way to get to see some of San Francisco’s favorite sights. A gourmet lunch buffet features options like asiago Caesar salad, bay shrimp salad, roasted chicken, garlic-herb roasted new potatoes and more. While guests enjoy lunch, they can take in views of San Francisco Bay’s flora and fauna, Angel Island and Alcatraz, and a live narration explores the history of Alcatraz. Please note that this tour doesn’t stop on Alcatraz Island.
Luxury Catamaran Sailing Cruise
A relaxing way to explore the San Francisco Bay is with the Luxury Catamaran Sailing Cruise. A drink bar and snacks are available for travelers’ enjoyment as they travel under the Golden Gate Bridge, around Alcatraz Island and even past a colony of sea lions. This is a peaceful San Francisco cruise option for families, and children under 5 ride for free.
City Kayak, located on San Francisco's Embarcadero close to the San Francisco Giant's ATT Park, offers a great way to experience San Francisco from Bay level, a point of view and a unique experience you'll not soon forget.
Think Escape Casino Tour
San Francisco Bay Area
San Franciscans may be familiar with Think Escape's party buses that shuttle the late-night crowds to and from various city nightclubs, but the Cache Creek Casino Escape is a little-known gem among Bay Area destinations. With personal charter service on the luxurious Fantasy Limo Bus to Cache Creek Casino and Resort, the Cache Creek Casino Escape tour is a smart choice for San Franciscans looking for a little gaming fun or planning a large group activity