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 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

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884

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 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

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884

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. These tools also provide the perfect response mechanism for communication with the FDA. 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? How to conclude a project "on time" and "within budget"? 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. Growing high-profile field problems indicate that much project management is poor or non-existent. Buy up-front time for proper project planning. 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:
Why formal Project Management
The three most common tools
How to compile
Gantt, CPM, PERT
Simple construction techniques
Work breakdown Structure, Milestones, Tasks
Effectiveness -- Determining and Monitoring
A "New Product" Template
One "Remediation Response" Template+B4
Who Will Benefit:
Senior management in Drugs, Devices, Biologics, Dietary Supplements
QA
RA
R&D
Engineering
Production
Operations
Consultants