This 2-day course will cover managing a supplier for the entire lifecycle of the relationship, beginning with identification and qualification of a supplier and continuing through building a relationship, risk management, ongoing assessment (including auditing) and finally planning for an exit. The course will show attendees how to use risk assessment for ranking suppliers and reducing the number of audits that are necessary to effectively manage suppliers. Strategies for determining whether a supplier will be sole source will be included. Exercises will help attendees develop their own supplier scorecard based on the requirements of their company and develop quality agreements that will ensure clear lines of communication. Attendees will take away strategies for the ongoing monitoring of supplier process performance and for managing nonconforming incidents and changes.
Why Should You Attend:
- Understand the benefits of effective supplier management
- Learn about the regulatory requirements for supplier management
- Understand how to develop a strategy for suppliers based on your supply chain
- Be able to analyze the cost of manufacturing vs. purchasing
- Understand how to select a supplier or contract manufacturer
- Understand the basics of building a supplier relationship
- Be able to develop a quality agreement that provides valuable guidance
- Learn how to perform risk assessments on suppliers and how to make decisions based on that assessment
- Learn how to develop a plan for supplier performance monitoring
- Understand how to manage failures and how to work with a supplier for improvement
- Understand the methods of supplier assessment and when to apply each
- Learn techniques for auditing a supplier and for follow-up and closure of the audit
- Learn how to effectively manage supplier exits and the transition to a new supplier
In-Person Seminar going Virtual with increased learner satisfaction.
Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:
- The real-time and live presentation as in in-person events
- Private chat for company-specific conversation – the same as you would get in an in-person seminar
- Opportunities to connect with your peers to share knowledge at a different time and have group discussions
- Live workshop activities
- Live Q&A during the event and offline Q&A assistance after the event
- As usual more content, activities and case studies and now adding homework for a comprehensive understanding
- Certification
Areas Covered:
- The benefits and components of a supplier management program
- Regulatory requirements for managing suppliers and contract manufacturers
- Strategic decision making for good supplier management
- How to manage risk and reduce the costs associated with having suppliers
- The steps involved in selecting and onboarding a supplier
- Developing good supplier relationships including managing improvement and nonconforming events
- Writing effective and useful quality agreements
- Reviewing supplier performance and making performance-based decisions
- How to perform a desktop assessment and a supplier audit (and when to use each)
- Managing supplier transitions
Who will Benefit:
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
- Quality Assurance Managers
- Quality Control Supervisors
- Quality Engineers
- Procurement Professionals
- Drug Development Scientists
- Medical Device R&D Engineers
- Supply Chain Managers
Topic Background:
Effective management of suppliers and contract manufacturers is an integral component of a quality management system. Suppliers are an integral part of the supply chain and, therefore, the process of production and delivery should by understood and supplier relationships developed and improved. Supplier failures can increase the cost of poor quality through excess inventory, downtime, additional testing, and customer satisfaction. On the other hand, a significant strategic advantage can be gained by excellent supplier management. One of the seven quality principles of ISO 9001 is to build relationships with suppliers because it is a critical component of sustained success.
Pharmaceutical and medical device manufacturers have a mandated responsibility for ensuring the suppliers meet regulatory requirements and produce good quality product. FDA regulations CFR 210 and 211 require pharmaceutical companies to assure the quality of the product they put into interstate commerce regardless of where it or any of its components were manufactured. The Q10 Pharmaceutical Quality System Guidance provides additional details on the agency’s expectations for supplier management. For Medical Device Manufacturers, 21 CFR 820.50 places the burden on the purchasing company to establish purchasing controls. European regulations similarly require effective supplier quality management.
- Session 1: Overview of Supplier and Contract Manufacturer Management
- Entire lifecycle for relationship from identification and qualification to building relationship to risk management, ongoing assessment, exit planning
- Risk management for ranking suppliers and reducing number of audits
- Strategies for sole sourcing where applicable
- Understand benefits of effective supplier management
- Planning through an exit
- Session 2: This session covers fundamental aspects of supplier quality management. Leading with principles of lean documents and lean configuration, it then covers the basics of supplier quality management, and risk management considerations.
- Why is lean information management important?
- Lean documents and lean configuration concepts
- Importance of information to the supplier quality management process
- Fundamentals of Supplier Quality Management
- Risk-based approach to QMS and Supply Chain
- Recent changes to standards
- Session 3: This session begins with the supplier relationship and quality alignment, then presents making a proper discovery, the supplier qualification and remediation
Supplier qualification process and part quality overview- Part 1 – Success begins with proper discovery
- Part 2 – Supplier qualification and remediation process
- Part 3 – Design requirements traceability matrix
- Session 4:
- Exercises will help attendees develop their own supplier scorecard based on the requirements of their company and develop quality agreements that will ensure clear lines of communication.
- Attendees will take away strategies for the ongoing monitoring of supplier performance and for managing nonconforming incidents and changes.
Jose Mora
Biotechnology Consultant and Owner, Atzari Consulting, L.L.C.
Jose Mora, is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years Mr. Mora 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, Jose 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.
Jose 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.
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Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.
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Cancellations and Substitutions for Virtual Seminars & Webinars:
Written cancellations through fax or email (from the person who has registered for the training) received at least 10 calendar days prior to the start date of the event will receive a refund — less a 30% administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event. On request by email or fax (before the training) a credit for the amount paid minus administration fees (30%) will be transferred to any future ComplianceOnline event and a credit note will be issued. Substitutions may be made at any time. No-shows will be charged the full amount. Some topics and speakers may be subject to change without notice. Offers:Testimonials
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