This comprehensive supplier management course is designed to enhance your skills in effectively managing supplier relationships throughout their lifecycle. From supplier identification and qualification to building strong relationships, risk management, continuous assessment, and exit planning, this course covers it all. Learn how to leverage risk assessment techniques to rank suppliers and minimize the need for extensive audits. Gain valuable insights into determining whether a supplier is suitable for sole sourcing. Engage in practical exercises to create your own customized supplier scorecard tailored to your company's requirements and develop quality agreements that promote clear communication. Walk away equipped with strategies for ongoing supplier process performance monitoring and efficient management of nonconforming incidents and changes.
Learning Objectives:
- 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
Course Content
DAY 1Session 1Session 2Session 3DAY 2Session 4Session 5Session 6
Objectives:
Understanding Regulatory Requirements and Standards for Supplier and Contract Manufacturer (CM) Management:
The Cost of Poor Quality from Suppliers and CMs:
Strategic Management of Suppliers:
Risk Management - A Lifecycle Approach:
Supplier Qualification:
Supplier Qualification:
Making your Supplier Quality Agreement a Great Resource:
Monitoring Your Supplier’s Performance to Reduce Risks and Costs:
Partnering with a Supplier or CM for Improvement:
Supplier Assessments:
Handling Supplier Transitions:
Speaker
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.
Who Should Attend
- Quality Assurance Personnel & Management
- Quality Control Personnel & Management
- Laboratory Supervisors
- Quality Engineers
- Procurement Professionals
- Drug Development Scientists
- Medical Device Development Scientists
- Supply Chain Personnel & Management
