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Project Management for FDA Regulated Companies

Event ID :- 1674 RWE
Event Type :- Webinar
Date :- Expired ( Past Event )
Venue :- Online
Organised by :- Compliance Online

This project management training for FDA regulated companies will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. It will focus on proven tools and techniques for successful development and implementation of project management planning.

Why Should You Attend:

The FDA expects companies to manage projects formally, with a written plan to include regulatory requirements, design and/or change control, with consideration of all applicable standards, and to demonstrate progress against plan. The EU MDD and their notified bodies are no different.

How can this be done from a project's inception How can lean principles be incorporated from project inception? What is "failing fast" in the "build, measure, learn, re-evaluate / decide loop Can Agile principles mesh with FDA's documentation requirements? How can a Project Leader or Project Manager ensure critical elements are not omitted until late in the project when disaster looms? How to gain management support for the Milestones, Tasks, Timelines

Areas Covered in the Webinar:

Meet key requirements of the CGMPs/ISO; Quality Plans

"Failing Fast" Formal Lean Project Management

The Three Most Common Tools - Gantt, CPM, PERT

Work breakdown Structure, Milestones, Tasks

Who Will Benefit:

This webinar will provide valuable assistance to all FDA-regulated companies that need an easy to implement, easy to explain, and repeatable methodology. It will provide the basic tools to assist in-house personnel to be trained in project management tools and techniques, targeted specifically to the regulated medical products industries, under cGMP and EU 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. The employees who will benefit include:

Project Managers

Senior management

Regulatory affairs

Quality Assurance / QAE


R&D and Engineering

Topics Covered :


More Details : https://www.complianceonline.com/project-management-for-fda-regulated-companies-webinar-training-701758-prdw?channel=Upcomingengineeringconferences