Webinar On Project Management for Computer Systems Validation

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. 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 detailed webinar 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 in a more effective manner.

Areas Covered in the Session :

Basics of Project Management

21 CFR 11 and Computer Systems Validation (CSV)

Project Planning for a Computer Systems Validation Project

CSV Deliverables

Hiddent CSV Deliverables

Metrics & Gantt Charts

Common Pitfalls and How to Avoid them

The 10 Deadly Sins!!

Who Will Benefit:

Project Managers

IT Management

Business Process Owners

Quality Managers

Quality Engineers

GxP

Consultants

Price Tags:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

$ 299