Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

Join us for a webinar on October 07 for a discussion of the webinar 

This project management training for FDA regulated companies will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. It will focus on proven tools and techniques for successful development and implementation of project management planning.

Why Should You Attend:

The FDA expects companies to manage projects formally, with a written plan -- to include regulatory requirements, design and/or change control, with consideration of all applicable standards, and to demonstrate "progress against plan". The EU MDD and their notified bodies are no different.

How can this be done from a project's inception? How can lean principles be incorporated from project inception? What is "failing fast" in the "build, measure, learn, re-evaluate / decide loop"? Can Agile principles mesh with FDA's documentation requirements? How can a Project Leader or Project Manager ensure critical elements are not omitted until late in the project when disaster looms? How to gain management support for the Milestones, Tasks, Timelines?

This webinar will provide valuable guidance to regulated companies in development and implementation of new Lean Project Management Planning concepts including some Agile principles, 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. Learn how regular use of a few simple but powerful tools will virtually eliminate "firefighting" in a new project.

Attend this training to understand how one can 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 in the Webinar:

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

Who Will Benefit:

This webinar will provide valuable assistance to all FDA-regulated companies that need an easy to implement, easy to explain, and repeatable methodology. 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. It will discuss and provide examples of the most common project management tools and provide a major example for immediate use. 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

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Faculty John E Lincoln

John E Lincoln


John E. Lincoln, consultant, has successfully designed, written over 50 ISO 14971-compliant Risk Management Files / Reports, including FMECA and FTA analysis, many in response to FDA 483 observation, which have subsequently passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development / design control projects; with over 24 years of experience, primarily in the medical device industry – working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco / Mallinckrodt. John serves on the Reader and Editorial Review Boards of MDDI Magazine and the Journal of cGMP.

Choose a Pricing Option

$199

Live Webinar - Single Participant 60-mins

You get one log-in for the live 60-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email

$399

Group Up to 5 Participants

You get 5 log-in for the live 60-minute webinar for all the participant, presentation materials and the opportunity to ask questions by phone and email


$289

Recorded Access Single - 6 month Access

You'll have access to one log-in for an archived recording of the entire 60-minute webinar, including the Q&A period, for 1 participant. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session


$389

Training DVD

Within 48 hours delivered - Lifetime Access ,Audio recording of a webinar and reference manual delivered by download. Listen anytime on any compatible device.


$399

Live + Recorded Access

You get one log-in for the live & recorded 60-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email