Best Practices for a Compliant, Lean Supplier Management Program
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Speaker : JOSE IGNACIO MORA
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When : Friday, April 18, 2025
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Time : 01 : 00 PM EST
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José Mora is a Principal Consultant specializing in Manufacturing
Engineering and Quality Systems. For over 30 years he has worked in the
medical device and life sciences industry specializing in manufacturing,
process development, tooling, and quality systems. Prior to working
full time as a consulting partner for Atzari Consulting, José served as
Director of Manufacturing Engineering at Boston Scientific and as
Quality Systems Manager at Stryker Orthopedics, where he introduced
process performance, problem solving, and quality system methodologies.
During that time he prepared a white paper on the application of lean
manufacturing methods to the creation and management of controlled
documents and a template for strategic deployment. José led the launch
of manufacturing at a start-up urology products company as Director of
Manufacturing for UroSurge, Inc. at the University of Iowa’s business
incubator park in Coralville, IA, creating a world-class medical device
manufacturing operation, with JIT, kanban systems, visual workplace and
lean manufacturing practices. José worked for 10 years at Cordis
Corporation, now a Johnson & Johnson company, where he led the
successful tooling, process development and qualification of Cordis’
first PTA (percutaneous transluminal angioplasty) catheter. His medical
device experience includes surgical instruments, PTA & PTCA
dilatation and guiding catheters, plastic surgery implants and tissue
expanders, urology implants and devices for the treatment of
incontinence, delivery systems for brachytherapy, orthopaedic implants
and instruments, and vascular surgery grafts and textiles. During his
time at Cordis, José managed the Maintenance and Facilities Department,
taking that operation to a level rated as “tops” by the UK Department of
Health and Social Services (DHSS) during one of their intensive audits.
Jose managed Manufacturing Engineering as part of the Guiding Catheter
Core Team of managers, a team that took the Cordis Guiding Catheter
business to lead the market, bringing it up from fourth place. By
introducing world-class techniques, the Guiding Catheter design and
manufacturing was completely re-engineered for robust design and
tooling, under Jose’s leadership. He was also instrumental and played a
leadership role in the complete re-engineering of the Tooling Control
System, including design drafting, the tool shop and technical support.
Wherever he has worked, he has a track record of introducing world-class
methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of
Constraints, Lean Manufacturing, Five S (Visual Workplace), process
validation to Global Harmonization Task Force standards, and similar
approaches.
Notified bodies and the FDA cannot require your suppliers to meet the quality system regulations, so they must make sure you are exercising sufficient control over those suppliers. You must make sure your supplier management and system meets all required regulations, especially for critical suppliers. Sure, you depend on your suppliers to provide you with goods and services, but can your system prove that you have sufficient control over your suppliers to assure auditors and regulatory agencies that your product is safe and meets all your requirements? Your supplier management program can be in compliance, but is it cost effective? If not, your unquantifiable overhead costs may be out of control. Is your supplier management program collaborative with your suppliers? If your company is too demanding of your suppliers, you risk alienating them or even worse losing them – try explaining that to your supply chain management!
This class will review the QSR and ISO requirements for supplier evaluation, including defining the types of suppliers that require evaluation, including “critical” suppliers and outsourced processes. The QSR and ISO requirements for supplier assessment will be defined as well. The webinar will discuss the application of a risk-based process resulting in a customized supplier management system.
Areas Covered
- Supplier Selection
- Review of FDA and ISO requirements
- Types of suppliers that must be qualified
- Defining critical suppliers
- Classification of suppliers
- Outsourced processes
- The Quality Agreement
- Recommended Practices
- Supplier Assessment
- Review of FDA and ISO requirements
- Recommended Practices
- How to avoid “Death by Supplier Audit”
- Documentation requirements
Who Should Attend
This webinar will provide valuable assistance to all regulated companies that are interested in implementing and maintaining a supplier management program that is both compliant and cost-efficient. The employees who will benefit include:
- Supply chain management
- Buyers
- Purchasing management
- CAPA Coordinators
- Regulatory management
- QA management
- Executive management
- Internal auditors
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$199.00
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