Lean-Agile Project Management in a cGMP Environment - Webinar By GlobalCompliancePanel

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Category online training,Lean-Agile Project Management,cGMP Environment,FDA,Formal Project Management,Gantt, CPM, PERT,Failing Fast

Deadline: June 06, 2012 | Date: June 06, 2012

Venue/Country: Online Training, U.S.A

Updated: 2012-05-09 19:06:54 (GMT+9)

Call For Papers - CFP

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 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 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. 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 for 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

Price List:

Live : $245.00

Corporate live : $995.00

Recorded : $295.00

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http://www.globalcompliancepanel.com

Phone: 800-447-9407

Fax: 302-288-6884