GXP Solutions | Computer System Validation (CSV) Training

Computer System Validation (CSV) Training

These CSV training courses focus on validation activities relating to both clinical and commercial products. To ensure that software meets end-user and regulatory requirements for FDA 21 CFR Part 11 and EMA Annex 11 requirements. The course is a complete training solution or may serve as a refresher course for those working in CSV environments.

Note

Course content can be tailored to your business needs.

All courses are live group or webinar training events only.

Course 1 - Computer System Validation (CSV) Regulations

Computer System Validation (CSV) course focuses on developing and implementing regulated computer systems with an appropriate level of documented evidence to satisfy FDA expectations.

Introduction
Module 1: The regulatory expectations for computer validation
Module 2: Relevant FDA warning letters
Module 3: The tasks and deliverables expected for computer validation.
Module 4: Why validation processes vary so much.
Module 5: Strategies for practical, yet defensible computer validation
Module 6: SOPs required for system operation and maintenance.
Module 7: 21 CFR part 11 and its implications for common regulations.
Module 8: An active discussion of part 11 examples and audience questions
Module 9: The implications of GAMP 5 on computer validation

Course 2 - Computer System Validation (CSV) Auditing Course

Computer System Validation (CSV) Auditing course focuses on how to evaluate a computerized system for an appropriate level of documented evidence to satisfy regulatory expectations.

Introduction
Module 1: The regulatory expectations for computer validation
Module 2: Relevant FDA warning letters
Module 3: The tasks and deliverables expected for computer validation.
Module 4: Why validation processes vary so much.
Module 5: Strategies for practical, yet defensible computer validation
Module 6: SOPs required for system operation and maintenance.
Module 7: 21 CFR part 11 and its implications for common regulations.
Module 8: An active discussion of part 11 examples and audience questions
Module 9: The implications of GAMP 5 on computer validation