The Advanced Certification Program in Pharmaceutical Computer System Validation (CSV) provides comprehensive training in the validation of computerized systems used across the pharmaceutical, biotech, and medical device industries. The program covers CSV principles, regulatory frameworks, validation lifecycle documentation, testing practices, data integrity, system qualification, and audit readiness within GxP environments.

The main objective of this course is to provide attendees with a strong foundation in Software Validation, Computer Systems Validation, and the latest requirements for Electronic Records and Electronic Signatures. The program includes an overview of FDA and European regulatory expectations with practical exercises demonstrating real-world implementation. The course also covers the application of these requirements to the validation of both computer hardware and software systems used in Manufacturing, QA, Regulatory, and Process Control functions.

Additionally, the course explains current FDA requirements and guidance for 21 CFR Part 11, EU Annex 11, and Quality Risk Management, enabling participants to apply these principles in CSV activities.

This highly interactive CSV program uses real-life examples and proven techniques to help reduce validation and maintenance costs—often by up to two-thirds—while maintaining compliance in regulated environments.