A comprehensive 2-day program covering the full supplier lifecycle — from qualification and risk assessment to quality agreements, performance monitoring, and supplier exits.
Includes live access & course materials
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.
Poorly managed supplier relationships are one of the leading causes of regulatory findings, quality failures, and supply chain disruptions in FDA-regulated industries. Most organizations rely on reactive approaches — auditing after problems arise, managing nonconformances without root cause strategy, and lacking the tools to assess supplier risk proactively.
This seminar gives you the frameworks, templates, and practical exercises to build a supplier management program that satisfies FDA, EU, and ISO requirements — while actually reducing audit burden and operational cost.
Leave with ready-to-use tools: a risk assessment template, a supplier scorecard, and a quality agreement framework — all customizable for your organization.
Thirteen practical objectives covering every stage of the supplier management lifecycle in FDA-regulated environments.
Understand the benefits of effective supplier management.
Learn the regulatory requirements for supplier management.
Understand how to develop a strategy for suppliers based on your supply chain.
Analyze the cost of manufacturing vs. purchasing to make smart make/buy decisions.
Understand how to select a supplier or contract manufacturer.
Understand the basics of building a strong supplier relationship.
Develop a quality agreement that provides valuable guidance.
Perform risk assessments on suppliers and make decisions based on that assessment.
Develop a plan for supplier performance monitoring.
Manage failures and work with a supplier for continuous 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.
Effectively manage supplier exits and the transition to a new supplier.
Four focused areas that will transform how your organization manages suppliers across the full lifecycle.
Cover the entire supplier lifecycle — from identification, qualification, and onboarding through performance monitoring, improvement, and controlled exit strategies.
Apply risk assessment techniques to rank and categorize suppliers — reducing the audit burden while maintaining full regulatory compliance and effective oversight.
Walk away with ready-to-use tools: a risk assessment template, a customizable supplier scorecard, and a quality agreement framework tailored to your organization.
Understand FDA, EU, and ISO requirements for supplier and contract manufacturer management — and learn from real regulatory finding examples to avoid common gaps.
Each day runs 10:00 AM – 3:00 PM ET (3:00 PM – 8:00 PM GMT) with three structured sessions per day.
* Includes break
* Includes break
* Daily Wrap-up and Discussion
* Includes break
* Includes break
* Seminar Closeout
John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years of 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, across 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.
John has held positions in Manufacturing Engineering, QA, QAE, and Regulatory Affairs up to Director and VP (R&D) level. He has prior experience in military, government, electronics, and aerospace sectors. He has published numerous articles in peer-reviewed journals and conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis/management, FDA/GMP audits, validation, and root cause analysis. John writes a recurring column for the Journal of Validation Technology and is a graduate of UCLA.
Join John E. Lincoln for this intensive 2-day seminar and walk away with the frameworks, templates, and strategies to build a world-class supplier management program.