Computer System Validation is required by the FDA and many other international regulatory agencies. On-site trainings, you will be with our experts in front of the systems and you will learn why regulatory agencies, such as the FDA, require computer system validation. You will learn which of your systems require validation – and which do not. This includes custom-built applications, commercial off-the-shelf systems, and spreadsheets. Computer System Validation on-site training topics:
- What is Computer System Validation (CSV)
- Why should you perform CSV
- Which regulatory agencies require Computer System Validation
- 21 CFR Part 11 & EU GMP Annex 11 Assessments
- Which systems need to be validated
- What are the consequences of not validating systems
- Data Integrity breaches
- Prospective and Retrospective validation approach
- GAP analysis and Risk Assessment on computer systems
- Periodic review of computer systems
Our experts at ICCON Consulting have prepared on-site educational and technical trainings to help you apply the FDA, ICH, and Eudralex risk-based validation concepts to your computerised systems validation projects. Also, our experienced Business Partners are ready to give cGMP trainings and seminars to your organization.
Trainings cover the essential principles using a risk based approached to Computer Systems Validation (CSV) and are designed for professionals seeking training in a practical approach in meeting the regulatory requirements, by using a risk based approach, and an understanding of Good Automated Manufacturing Practice (GAMP5), Annex 11 and CFR Part 11.