Project Management for Computer Systems Validation

Description:
Project Management is defined as the planning and organization of an organization's resources in order to move a specific task, event or duty toward completion. However, Validation of Computerized Systems has a very specific set of tasks that are often mismanaged, resulting in missed deadlines, increased costs, and regulatory risk, and missed times to market for a company’s product.
Agenda

Project Management Basics
21 CFR 11 and Computer Systems Validation (CSV)
The Project Charter
CSV Deliverables
Hiddent CSV Deliverables
Metrics & Gantt Charts
The 10 Deadly Sins!!
Q&A

Why Should you Attend:
Per the CDRH, 20% of product recalls in the medical device industry are due to faulty software!!! Yet, these human, financial and reputation capital expensive issues, can be averted with computerized systems validation and 21 CFR 11 compliance.

The Project Manager for a Validated Computerized System, has to deliver on time and on budget, but with the added risk of having to meet regulatory compliance, often causing project overruns, regulatory findings and missed times to market. This class will explain the basic tenets of project management, the basic tenets of 21 CFR 11 compliance for Computer Systems Validation and will show how to marry the two, to deliver on time and on budget while meeting regulatory compliance requirements.

Objectives of the Presentation:

Basics of Project Management
Basics of Computer Systems Validation
Project Planning for a Computer Systems Validation Project
Common Pitfalls and How to Avoid them

Who can Benefit:

Project Managers
IT Management
Business Process Owners
Quality Managers
Quality Engineers
GxP
Consultants