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Supplier Management for Medical Device Manufacturers: 2-day In-person Seminar

By:
Dan O'Leary, President at Ombu Enterprises, LLC
Location :-
Grand Hyatt San Francisco, CA
| Thursday, November 20, 2014 | Friday, November 21, 2014

Course Description:

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.



Learning Objective:

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




Course Outline:

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

  1. Introduction/Fundamentals – Regulatory Requirements
    • 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
  2. Planning the Supplier Management Program
    • 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
  3. Planning Supplier Selection
    • 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
  4. Potential Suppliers
    • 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

  1. Supplier Selection
    • 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
  2. Implementing Supplier Controls
    • 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
  3. Monitoring, Measuring, and Evaluation
    • 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
  4. Feedback and Communication
    • Supplier scorecards
    • Corrective action requests
    • Supplier meetings
    • Case Study and exercise on supplier scorecards
  5. Evaluating your Program
    • Supplier management maturity models
    • FDA’s QSIT
    • GHTF guidance on auditing supplier control
    • Case Study and exercise on maturity models





Meet Your Instructor

Dan O'Leary
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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$1,299.00

Seminar One Registration

November 20-21, 2014, San Francisco, CA
(Early bird price valid till September 30, 2014)
Actual Price: $1,599

$6,099.00
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November 20-21, 2014, San Francisco, CA
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Register Now and Save $300 (Last call to save)
For Registrations till September 30, 2014 $1,299
Actual Price $1,599
Early bird seats are limited and based on first-come, first-serve.

The registration fee includes: the workshop; all related course materials; morning tea/coffee, lunch and afternoon tea/coffee on both days.


For discounts on multiple registrations, contact customer care at +1-888-717-2436.

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Yes, I want to attend "Supplier Management for Medical Device Manufacturers: 2-day In-person Seminar".

If you are paying by check:

Checks should be payable to MetricStream Inc. (our parent company) and mailed to:
2600 E. Bayshore Road
Palo Alto, CA 94303
USA

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10+ Attendees - Get 30% off

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Venue

Location :

Special Offer for the attendees of this seminar:

Rooms available at 15% discount and with free internet.

Use the code "CR88975" at the time of booking to avail of this offer.

Please note: Hotel rooms are limited and based on availability.




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How to Reach

General Driving Directions:

From San Francisco International Airport: 14 miles
  • Take 101 North toward the San Francisco and Bay Bridge.(Cambridge)
  • Exit 280 North toward "Port of SF/280 North". Stay in left lane and 280 becomes King Street.
  • At 2nd light, turn left onto 3rd St and go 8 blocks to Market St.
  • Cross over Market St. (which becomes Kearny St.) and continue 2 blocks.
  • Turn left on Sutter St. Go 2 blocks to Stockton and the hotel is located on the left corner.

From Oakland Airport: 20 miles
  • Take 880 North toward San Francisco and cross over on the Bay Bridge.
  • Take the Fremont St. Exit (on right) & proceed 1/2-block on Fremont St.
  • Turn left onto Howard St & Turn right onto 3rd St.
  • Cross Market St. (Street changes to Kearny).
  • Take Kearny 2 blocks to Sutter St. and turn left.
  • Take Sutter St. to Stockton St. and turn left.

From San Jose International Airport: 46 miles
  • Take 101 North toward San Francisco for approximately 43 miles
  • Take I-80 East toward Bay Bridge/Oakland.
  • Exit at Fourth Street toward Embarcadero.
  • Make a slight left onto Bryant Street.
  • Then a left onto Third Street & Third Street will become Kearny Street.
  • Take Kearny 2 blocks to Sutter St. and turn left.
  • Take Sutter St. to Stockton St. and turn left to reach the Hotel.

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.





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