Lean-Agile Project Management in a cGMP Environment Course "Efficient Lean-Agile Project Management in a cGMP Environment" has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification upon full completion.
Date & Time:
Wednesday, June 6, 2012
10:00 AM PDT | 01:00 PM EDT
Duration: 90 Minutes
Instructor: John E Lincoln
Price : $245.00
John E Lincoln Consultant, Medical device and Regulatory affairs,
(for one participant)
Overview: This webinar is not a project management certification course. 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. 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.
Why Should You Attend:
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 peerreviewed 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 FDAregulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA. ...more
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 Suggest a Topic More Webinars notified bodies are no different. How can this be done from a Your Necessity is our Priority 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, 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.
Areas Covered in the Session: l
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 for Failure Fast The Build, Measure, Learn, Re-evaluate Loop A Template / Example
One Major, But Often Neglected, Use
Click here to register for this webinar Who Will Benefit: l
Senior Management in Drugs, Devices, Biologics, Dietary
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Production Operations Consultants; others tasked with project leadership responsibilities
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel
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