OVERVIEW

Computer System Validation is organized by The Center for Professional Innovation & Education (CfPIE), Inc. and will be held from Nov 17 - 19, 2026.

Description:
This fifteen-hour course focuses on developing and implementing computer systems performing regulated operations with an appropriate level of documented evidence to satisfy US and EU agency expectations. The course targets deliverable document content and how to avoid rework and unnecessary expense through a proactive approach. Examples include discussions on practices that add value to computer validation and common practices that add overhead with minimal value. The core elements of a satisfactory computer validation program will be emphasized.

Topics to be discussed include:

The regulatory compliance expectations for computer validation
The tasks and deliverables expected for computer validation
Over 280 FDA warning letters for compliance issues related to computer validation topics
Why validation processes vary so much
How Computer Software Assurance (CSA) adds value to validation and reduces paperwork
Strategies for practical, yet defensible computer validation
How cybersecurity concepts are covered in computer validation
SOPs required for system operation and maintenance
21 CFR part 11 and its implications for common regulations
An active discussion of part 11 examples and attendee questions
How GAMP 5 can assist with computer validation
Validating cloud-based and Software as a Service (SaaS) systems
Considerations for validating digitalized systems and systems using Artificial Intelligence (AI)
Auditing GXP computer systems and suppliers

Learning Objectives:
The course is designed to provide a thorough understanding of computer system validation. In addition, the course will address how 21 CFR Part 11 (electronic record/electronic signature requirements) fits into the validation process. The attendee will be familiar with expected content for computer validation deliverables through examination of example documents, as well as how to develop the validation rationale for a variety of circumstances.