This webinar is not a project management certification course. It is
designed to provide the non-project manager with the tools / techniques
necessary to assist in achieving a result or deliverable to achieve that
end, and document the activity over time.
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 varients such as "dashboards" will also be presented. 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
Why should you Attend
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 ommitted 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
- Formal Project Management to Fulfill Common cGMP Requirements
- "Failing Fast" Lean Project Management
- The Three Most Common PM Tools Gantt, CPM, PERT + others
- Work breakdown Structure, Milestones, Tasks
- Drive Success ofr Failure Fast
- The Build, Measure, Learn, Re-evaluate Loop
- A Template / Example
- One Major, But Often Negleted, Use
Who Will Benefit
- Senior management in Drugs, Devices, Biologics, Dietary
- Consultants; others tasked with project leadership responsibilities
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have 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, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.