GXP ACADEMY · PHARMA ROLES & CAREERS
Explore the responsibilities, capabilities and operational challenges faced by pharmaceutical professionals. Content designed to help you understand your role, make stronger decisions and build the next step in your career.
ARTICLES & INSIGHTS
Roles, quality systems, operational activities and regulatory topics explained with a practical approach.
How to make WMS/ERP audit-ready in GDP: CSV, ALCOA+, audit trail review, access control, backups, and IT change management. A practical approach for the Responsible Person.
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How to make your pharmacovigilance database audit-ready: a risk-based CSV approach, Annex 11/21 CFR Part 11 requirements, audit trail review, access control, backups, and E2B interfaces.
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Operational guide for Clinical RA on CTIS/CTA: Part I/Part II, IMPD, RFIs, substantial modifications, and audit readiness. Typical mistakes and a ready-to-use checklist.
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Advanced guide to GMP supplier qualification and Quality Agreements: risk-based audits, change notification, CoA and skip testing, supplier KPIs, contractors and CMOs
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After go-live in the cloud, compliance is won through change control, incident management, periodic review and continuous audit preparation.
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GMP inspection management, AIFA EMA FDA inspection, request log, front room back room, mock inspection, CAPA letter, 483 response, evidence package, closing meeting, inspection hosting team
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Prepare for your GMP audit. How to defend the Validation Master Plan (VMP) and Calibration Plan. Common mistakes and inspector expectations (FDA/EMA).
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Prepare for a GMP inspection (FDA, AIFA, EMA). Analysis of the most common production findings (483), data integrity, Annex 1, and audit readiness checklist.
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How to build Continued Process Verification (Stage 3): parameters, control charts, Cp/Cpk, data stratification, golden batch, and governance. With practical examples from the shop floor.
How to build Continued Process Verification (Stage 3): parameters, control charts, Cp/Cpk, data stratification, golden batch, and governance. With practical examples from the shop floor.
Operational FMD playbook for wholesalers: when to verify or decommission, how to manage NMVS alerts, quarantine workflow, and the Italian DataMatrix + bollino dual system.
Operational FMD playbook for wholesalers: when to verify or decommission, how to manage NMVS alerts, quarantine workflow, and the Italian DataMatrix + bollino dual system.
A practical method for defensible signal management: screening with SMQs, metrics beyond PRR such as ROR, EBGM, and IC, case-series assessment, decision logs, and label/RMP actions ready for PRAC and...
A practical method for defensible signal management: screening with SMQs, metrics beyond PRR such as ROR, EBGM, and IC, case-series assessment, decision logs, and label/RMP actions ready for PRAC and...
Drug-device combination products: what is really needed for MDR Article 117, GSPR, UDI/EUDAMED, ISO 14971 risk management, and audit readiness.
Drug-device combination products: what is really needed for MDR Article 117, GSPR, UDI/EUDAMED, ISO 14971 risk management, and audit readiness.
How to read uncertainty (k=2) and decision rule on calibration certificates: avoid false compliance, unexpected OOT events, and GMP findings.
How to read uncertainty (k=2) and decision rule on calibration certificates: avoid false compliance, unexpected OOT events, and GMP findings.
Advanced guide for Manufacturing Managers: distinguish change vs deviation, manage like-for-like changes, impact assessment, Established Conditions, and PACMP under ICH Q12 without findings.
Advanced guide for Manufacturing Managers: distinguish change vs deviation, manage like-for-like changes, impact assessment, Established Conditions, and PACMP under ICH Q12 without findings.
PRACTICAL GMP TOOLS FOR PHARMA
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