Testing 789
Course Description:
Most companies today are buying, rather than building, the computer systems that they use in their GxP-regulated activities. However, for pharmaceutical, biotech, medical device, and similar companies, computer system validation (CSV) is still required. But CSV responsibilities and approaches have changed.
Whether your solution is cloud-based, SaaS, COTS (commercial-off-the-shelf), or OOTB (out-of-the-box), this seminar has been designed to ensure that you leave knowing what to validate, how to validate, and when to leverage vendor-supplied documentation in your validation. You will also learn the necessity and power of vendor assessments and risk-based validation.
This computer system validation course incorporates FDA, ICH, and Eudralex expectations for risk-based computer system validation, and aligns with industry-wide standards, such as those defined by GAMP and PIC/S.
Our Approach to Computer System Validation Training:
Our experienced computer system validation consultants have designed a concise, yet thorough course to equip you with the information you need to validate purchased applications. A mixture of instructor lectures, class activities, and real-world examples will keep you engaged. And, there will be plenty of opportunities to get answers to your company-specific questions.