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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:

   

  

Register Now

Instructor Profile:

Wednesday, June 6, 2012

10:00 AM PDT | 01:00 PM EDT

Duration: 90 Minutes

Instructor: John E Lincoln

Location: Online

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

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"Failing Fast" Lean Project Management The Three Most Common PM Tools -- Gantt, CPM, PERT + others Work breakdown Structure, Milestones, Tasks

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Drive Success for Failure Fast The Build, Measure, Learn, Re-evaluate Loop A Template / Example

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One Major, But Often Neglected, Use

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Click here to register for this webinar Who Will Benefit: l

Senior Management in Drugs, Devices, Biologics, Dietary

 

 


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Supplements QA

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RA

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R&D Engineering

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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

About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel www.globalcompliancepanel.com 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe


Lean-Agile Project Management in a cGMP Environment