Pharma Roles & Careers
Practical Guide to the CTD/eCTD Dossier: Drug R...
Learn how to manage the CTD/eCTD registration dossier. A step-by-step guide to the 5 Modules (ICH M4), submission, variation management, and the lifecycle.
Practical Guide to the CTD/eCTD Dossier: Drug R...
Learn how to manage the CTD/eCTD registration dossier. A step-by-step guide to the 5 Modules (ICH M4), submission, variation management, and the lifecycle.
A Practical Guide to Deviations and CAPA: GMP M...
Learn how to manage deviations, investigations (root cause analysis), and CAPA (corrective actions) according to GMP. A practical guide for QA.
A Practical Guide to Deviations and CAPA: GMP M...
Learn how to manage deviations, investigations (root cause analysis), and CAPA (corrective actions) according to GMP. A practical guide for QA.
Practical Guide to Batch Release | EU GMP Annex
Step-by-step guide to batch release according to EU GMP Annex 16. The document checklist and management of deviations for QP.
Practical Guide to Batch Release | EU GMP Annex
Step-by-step guide to batch release according to EU GMP Annex 16. The document checklist and management of deviations for QP.
Validation vs. Calibration Manager: Why are the...
Discover the responsibilities of the Validation Manager (VMP, IQ/OQ/PQ) and the Calibration Manager (Calibration, OOT) in Pharma and why their integration is vital.
Validation vs. Calibration Manager: Why are the...
Discover the responsibilities of the Validation Manager (VMP, IQ/OQ/PQ) and the Calibration Manager (Calibration, OOT) in Pharma and why their integration is vital.
The Pharmaceutical Manufacturing Manager: Role ...
Who is a Manufacturing Manager in the GMP context? An analysis of responsibilities, differences between QA and QP, and the impact of EU GMP, FDA, and ICH Q10 regulations.
The Pharmaceutical Manufacturing Manager: Role ...
Who is a Manufacturing Manager in the GMP context? An analysis of responsibilities, differences between QA and QP, and the impact of EU GMP, FDA, and ICH Q10 regulations.
Who is the GDP Responsible Person? Role and Reg...
Find out who the GDP Responsible Person (RP) is according to the GDP regulation. Analysis of responsibilities, differences between GMP and QP, and qualification requirements.
Who is the GDP Responsible Person? Role and Reg...
Find out who the GDP Responsible Person (RP) is according to the GDP regulation. Analysis of responsibilities, differences between GMP and QP, and qualification requirements.