New and Realistic Lean Manufacturing can be a key to company success, by incorporating basic lean principles, while addressing FDA / CGMP requirements.
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 maintaing adherence to the reqired 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 ommitted until late in the project when disaster looms? What are the lean "endpoints"?
Areas Covered in the Webinar: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:
John E LincolnPrincipal, J E Lincoln and Associates
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 as a full-time 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 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, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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