Reduce COTS software validation using the 10 step risk based approach

Understand 10 step Risk based approach to validation, explore methods to decrease resource requirements and make documentation more manageable and understandable.

Who Will Benefit :

• Computer System users
• IT
• QA
• Managers
• Executives

Instructor Profile:

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 196 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular 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.