Project Management for FDA-Regulated Companies

John E Lincoln
Duration: 60 Minutes
Webinar Id: 604285
Instructor: John E Lincoln

Price Details

Recorded Webinar
$190. One Attendee
$390. Unlimited Attendees

Unlimited Attendees: Any number of participants

Recorded Version: Unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of live webinar)

Overview:

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 the development and implementation of Project Management Planning and Techniques for new product development, regulatory compliance audit responses, proof of "progress against the 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. 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 the 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.

Why you should 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 committed 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, and 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 the 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 or Failure Fast
  • The Build, Measure, Learn, Re-evaluate Loop
  • A Template / Example
  • One Major, But Often Neglected, Use

Who Will Benefit:

  • Senior management in Drugs, Devices, Biologics, Dietary
  • Supplements
  • QA
  • RA
  • R&D
  • Engineering
  • Production
  • Operations
  • Consultants; others tasked with Project Leadership Responsibilities

Speaker Profile
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.

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