This webinar takes the requirements of Part 11 and Annex 11 and details them into specific things to do for all three primary areas: SOPs, product features, and validation. It describes what to do to be compliant thereby avoiding 483s and warning letters. All required IT SOPs are covered. All industry standards product features are discussed. The 10-step risk-based validation approach is outlined so that the specific documents for a validation project are understood. This session will make your company more productive.

Learning Objectives:

- Understand which systems need to be validated.

- Learn the specifics for compliance.

- Avoid 483 and Warning Letters.

- Explore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation.

- Ensure data integrity, security, and protect intellectual property.

- Understand the current computer system industry standards for security, data transfer, and audit trails.

- Explore electronic signatures, digital pens, and biometric signatures.

- Understand which SOPs are required for the IT infrastructure.

- Know which product features to buy when purchasing COTS software.

- Learn how to reduce validation resources by using easy to understand fill-in-the-blank validation documents.

Who will Benefit:

IT
QA
QC
Laboratory staff
Managers
GMP, GCP, GLP professionals

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.