Lean Project Management For U.S. FDA-Regulated Industries

Both the FDA and the EU MDD expect companies to manage projects formally -- to include regulatory requirements, design and/or change control, with consideration of all applicable standards, and to demonstrate "progress against plan".

This webinar will provide valuable guidance to regulated companies in development and implementation of new Lean Project Management Planning concepts for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale. Three of the most common tools will be discussed. "Hit the ground running" with one very simple approach using common Excel- or Word-type PC applications programs. The speaker will discuss a few simple but powerful tools, the regular use of which will virtually eliminate "fire fighting" in a new project. You will learn how to incorporate lean principles into project management and reduce scheduling uncertainty, aid project team communication, prevent incomplete projects when time is running out, decrease product liability, assist in company-wide cost reduction efforts, with less chance of recalls, and an improved bottom line.

Areas Covered:

• Meet key requirements of the CGMPs/ISO with formal project mgmt.
• "Failing Fast" Formal Lean Project Management
• The Three Most Common Tools - Gantt, CPM, PERT
• Work breakdown Structure, Milestones, Tasks
• Drive Success or Failure Fast
• The Build, Measure, Learn, Re-evaluate Loop
• A Suggested New Product Template
• One Major, But Often Neglected, Use

Who Will Benefit:

This webinar is not a project management certification course. It's a project management for CGMP compliance course. It will provide the basic tools to assist in-house personnel to be trained in project management tools and techniques, targeted specifically to the regulated medical products industries, under cGMP and EU MDD/CE-marking compliance.

The following personnel from Medical Device, Diagnostic, Pharmaceutical, and Biologics fields will benefit:

• Project Managers
• Senior Management
• Regulatory Affairs
• Quality Assurance / QAE
• Production
• R&D and Engineering
• All personnel tasked with any project management responsibilities, and those who soon hope to be

Instructor Profile:

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 30 years experience in U.S. FDA-regulated industries, 16 of which has been as a full-time consultant. John has worked with companies from start-up o Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He has used the techniques discussed in this webinar in the actual field. He specializes in QA/RA / problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment, QMS/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). John also has prior experience in military, government, electronics, and aerospace. He's published many articles in peer reviewed journals, conducted workshops and webinars worldwide on virtually all CGMP activities. John is a graduate of UCLA.

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