Lean Manufacturing For U.S. FDA-Regulated Industries


Instructor: John E Lincoln
Product ID: 706960
Training Level: Intermediate to Advanced

  • Duration: 90 Min
New and Realistic Lean Manufacturing can be a key to company success, by incorporating basic lean principles, while addressing FDA / CGMP requirements.
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This webinar will provide valuable guidance to regulated companies in development and implementation of Lean into their manufacturing operations -- for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale.

Enjoy the increased throughput, faster processing, other benefits of lean, while also meeting US FDA / CGMP requirements. Moderate with what has been learned during Covid 19. Regular use of a few simple but powerful tools will virtually eliminate "fire fighting" in a new project. Incorporate lean principles into project management. Regular use can contribute greatly to achievement of lean goals. Basic lean principles will be discussed in an FDA-regulated industry: Value Stream Mapping. "failing fast" (also in Agile), flow, pull, takt time, kanban, kaizen, cells, SMED - putting all together.

Why Should You Attend:

The FDA expects companies to implement and manage manufacturing formally, fully documented -- to include regulatory requirements, design and/or change control, with consideration of all applicable standards. It is no different when incorporating lean principles into the manufacturing supply chain and manufacturing process.

The EU MDR and their notified bodies are no different. How can this be done while maintaining adherence to the required CGMPs? How can lean principles be incorporated from project inception? What is "failing fast" in the "build, measure, learn, re-evaluate / decide loop"? Five key elements of lean. Value, and Value Stream Mapping. Flow vs batch and queue, Pull, QFD, Takt time, kanban, cells, kaizen, SMED... Some basic tools. How can a Project Leader or Project Manager ensure critical elements are not omitted until late in the project when disaster looms? What are the lean "endpoints"?

Areas Covered in the Webinar:

  • "Failing Fast" Formal Lean Project Management
  • Manage the lean projects for success - Gantt, CPM, PERT

  • Value Stream Mapping; reduce queues vs. supply chain disruptions
  • Drive Success or Failure Fast
  • Takt time

  • Kanban

  • Kaizen

  • SMED

Who Will Benefit:

This webinar will focus on lean manufacturing tools specifically employed in the regulated medical products industries, under cGMP and EU MDR/CE-marking compliance. This applies to companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

  • Project Managers
  • Senior Management
  • Regulatory Affairs
  • Quality Assurance / QAE
  • Production
  • R&D and Engineering
  • All personnel tasked with any lean manufacturing project implementation responsibilities.
Instructor Profile:
John E Lincoln

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 41 years experience in U.S. FDA-regulated industries, 27 years as head of his own consulting company. 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 including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. 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, 5 chapters in the RAPS textbook on validation, conducted workshops and webinars worldwide on CGMP subjects. John is a graduate of UCLA.

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