Join our Computer System Validation Boot Camp to master FDA regulations, including 21 CFR Part 11, and gain hands-on experience in validation projects. Register to secure training materials, live ...

Join our Computer System Validation Boot Camp to master FDA regulations, including 21 CFR Part 11, and gain hands-on experience in validation projects. Register to secure training materials, live ...

In January 2011, the European Medicines Agency (EMA) announced the new revision of EudraLex Volume 4 (GMP) — Annex 11 “Computerised Systems” (1), and the consequential amendment of EudraLex Volume 4 — ...

This document outlines the evaluation of Molecular Devices’ microplate readers for use in regulated environments, referencing 21 CFR Parts 58, 211, and 820 and EudraLex Annex 15. 21 CFR Part 58 ...

1. European Commission, EudraLex, Volume 4, EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Annex 1, Manufacture of Sterile Medicinal Products, December ...

We have used our real-world experience to design a computer system validation course that not only meets FDA, ICH, and Eudralex expectations for risk-based validation, but also prepares you to ...

Join our Computer System Validation Boot Camp to master FDA regulations, including 21 CFR Part 11, and gain hands-on experience in validation projects. Register to secure training materials, live ...