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.
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.
Computerized System Validation training has been designed not only to meet FDA, ICH, and Eudralex expectations for risk-based validation, but also prepares you to implement these practices in your company.
This training covers the key concepts of a GxP computerized systems validation and compliance, including the key regulatory requirements and industry good practice based on GAMP5. Computerized System Validation is a basic GxP regulatory requirement. Inadequate and inapporppriate validation approaches can lead to serious compliance and quality issues. Compliant and validated computerized systems are a prerequisite for effective data integrity.
This training describes a practical and efficient framework for computerized systems validation, following current industry good practice, and gives attendees an appreciation of how these ideas may be applied to their own systems.
The training covers the following topics:
By the end of this course, you will:
* You can add the training you need on the specific subject in the description section.