Presentation Description:

This webinar describes efficient techniques for performing COTS validation. The 10-step risk-based approach to COTS software validation makes documentation more manageable and understandable. Learn how to increase productivity and minimize resources, usually saving two-thirds of the time and costs. Ensuring compliance of new and upgraded computer systems. Learn how to use risk management to improve system performance and promote process improvement. After you complete this webinar you will be ready to perform a validation project.

Who will Benefit?

Users of computer systems
IT
QA
QC
Laboratory staff
Managers
Executives

Learning Objectives:

· How to use the risk-based validation approach to lower costs.

· How to link requirements, specifications, risk management, and testing.

· Based on: "Risk-Based Software Validation – Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006).

· Reduce testing by writing test cases that trace to elements of risk management.

· Learn which documents the FDA expects to audit.

· Proven techniques that reduce software costs and implementation times.

· Increase corporate productivity and individual workforce member productivity.

· Efficiently create validation documentation.

· Decrease resource requirements.

· Make documentation more manageable and understandable.

· Avoid 483s and Warning Letters.

· Use resources effectively to perform effective validation while avoiding doing too much.

- How to implement a computer system to gain maximum productivity.

About Speaker

Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 206 mission critical laboratory, clinical, and manufacturing software implementation projects. His latest book is “Risk Based Software Validation - Ten easy Steps” (Davis Horwood International and PDA - www.pda.org, 2006) which provides fill-in-the-blank templates for completing a COTS software validation project.