Join this interactive two-day course to master cost-effective computer system validation. Learn the 10-step risk-based approach to cut compliance costs by two-thirds while meeting Part 11 and ...

The shift to Computer Software Assurance (CSA) provides opportunities to enhance compliance through critical thinking, risk-based assessments, and au ...

Computer systems subject to GCP requirements must be thoroughly and appropriately validated in accordance with FDA's guidance on computer system validation.

This 2-day course provides the regulatory background and guides attendees through the complete equipment qualification, calibration and computer system validation processes from planning to report. It ...

TheA Risk Based Approach To Data Integrity - Online Webinar Covering Validation/21 CFR 11 Compliance of Computer Systems - ResearchAndMarkets.com ...

The Board of the Eurasian Economic Commission has adopted Guidelines on Ensuring Data Integrity and Validation of Computerized Systems. The manual contains recommendations for pharmaceutical ...

The adoption will include all relevant departments, including Regulatory Affairs, ensuring compliance with key regulatory guidelines such as ANVISA's Computerized Systems Validation Guide (No. 33/ ...

He is the editor of Labcompliance, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books "Validation and Qualification in Analytical ...