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Full description:

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. The EU MDD and their notified bodies are no different.

This Project Management for FDA-Regulated Companies webinar 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. We will discuss one very simple approach using common Excel- or Word-type PC applications programs that can be used immediately. Three of the most common tools will be discussed. Regular use of a few simple but powerful tools will be showcased which will virtually eliminate "fire fighting" in a new project.

Intended audience: This webinar will provide valuable assistance to all regulated companies that need a repeatable methodology, and their in-house personnel trained in project management tools and techniques targeted specifically to the regulated medical products industries, under cGMP and MDD/CE-marking compliance. It will discuss and provide examples of the most common project management tools and provide a major example for immediate use. This applies to companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.

What you will learn:

• Meet key requirements of the CGMPs/ISO with formal project mgmt.
• Why formal Project Management.
• The Three Most Common Tools - Gantt, CPM, PERT.
• How to Compile - Simple Spreadsheet Techniques.
• Work breakdown Structure, Milestones, Tasks.
• Effectiveness -- Determining and Monitoring.
• A Suggested Template.
• One Major, But Often Neglected, Use.