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Webinar On U.S. FDA Project Management

  October 01, 2015  

Compliance Trainings, Mississauga

Description :

This webinar is not a project management certification course. However, it is designed to provide the tools necessary to assist those designing a result or deliverable to achieve that end. It will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques 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. Common variants such as "dashboards" will also be presented. Lean and Agile principles will be discussed, including potential pitfalls. A very simple approach using common Excel- or Word-type PC applications programs that can be used immediately will be highlighted. Regular use of a few simple but powerful tools will virtually eliminate "fire fighting" in a new project. Regular use can contribute greatly to reduction of scheduling uncertainty, incomplete projects when time is running out, increased product liability, assist in company-wide cost reduction efforts, with less chance of recalls, and an improved bottom line.

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

How can this be done from a project's inception?

How can a Project Leader or Project Manager ensure critical elements are not omitted until late in the project when disaster looms?

How to minimize scope creep?

What are the "lean" and "Agile"  benefits and shortcomings in the cGMP environment?

What is "failing fast" in the "build-measure-learn, re-evaluate / decide loop?

How to gain management support for the Milestones, Tasks, Timelines?

Use the Plan as a powerful tool with FDA auditors. Use variations on these tools for any project, from the smallest to major company projects. These techniques are not rocket-science, but require the implementation of formal methods with documented, and defensible rationale. Use these tools to bring predictability to your company's product development process. Use them to defend your remediation efforts with the FDA. Use them to prove "progress against plan".

Areas Covered in the Session :

The three most common PM tools -- Gantt, CPM, PERT + others

Work breakdown structure, milestones, tasks

Lean and Agile principles, advantages and potential problems

Drive success over failure fast

The build, leisure, learn,  re-evaluate loop

A template / example

One major but often neglected use


Who Will Benefit:

Principles in this webinar will apply to personnel / companies in the Medical Devices, Pharmaceutical, Diagnostic, and Biologics fields. The professionals who will benefit include all:

Senior management

Middle management





Manufacturing Teams

Operations Teams


cGMP instructors


Production Teams

Organized by: Compliance Trainings
Invited Speakers:

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 33 years experience in U.S. FDA-regulated industries, 19 years 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.

Deadline for Abstracts: 2015-10-07

For more information about this event please visit




To register this webinar 

E-mail: suzzane.d@compliancetrainings.com
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