Regulatory Updates & Responsibilities for the Qualified Person (QP)
Clarify non-delegable QP duties and strengthen batch certification decisions in a changing GMP landscape.
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We design and deliver fully customized training programs built around EU GMP, GDP, Annex 1, Annex 16, QP responsibilities, quality systems, data integrity, and operational excellence.
Every program is adapted to your site, your products, and your regulatory expectations, ensuring your teams gain practical, inspection-ready expertise.
Clarify non-delegable QP duties and strengthen batch certification decisions in a changing GMP landscape.
Read moreLearn a proven, step-by-step approach to prepare teams, close gaps, and perform in inspections.
Read moreMaster PV from process design to PPQ and continued verification, aligned with ICH Q8–Q12.
Read moreBuild a robust, defendable cleaning validation lifecycle, from limits and sampling to sustaining control.
Read moreDesign a science-based EM program with justified locations, frequencies, limits, and meaningful trending.
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