Pharmaceutical Regulatory Compliance: A Guide to Inspections (EMA/FDA)
Prepare for EMA/FDA inspections. A guide to regulatory compliance in Pharmacovigilance (RMP, PSUR) and Labeling (QRD) for RA professionals.
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Roles, skills and knowledge to grow your pharma career.
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.
✓ Pharma professions
✓ GxP capabilities
✓ Professional growth
ARTICLES & INSIGHTS
Useful knowledge for your professional journey.
Roles, quality systems, operational activities and regulatory topics explained with a practical approach.
Data Integrity (ALCOA+): Audit-Readiness Guide (EU GMP Annex 11)
Ensures Data Integrity (ALCOA+) and compliance with EU GMP Annex 11. QA Guide for Computerized Systems Validation (CSV).
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QP and Drug Importation: Managing Risk and the Global Supply Chain
Guide for QPs on importing pharmaceuticals from third countries (China, India) and outsourcing (CMO). MRA management, audits, Annex 16, and responsibilities.
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Out of Tolerance (OOT) Management: A 6-Step Practical Guide
What to do when an instrument is out of tolerance (OOT)? A step-by-step guide for calibration and QA managers on how to manage the anomaly, the impact on...
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GMP Department Management: Data Integrity, BPR and Validation
A practical guide for manufacturing managers: how to manage batch records (BPR), apply data integrity (ALCOA+), and supervise validations (IQ/OQ/PQ).
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How to Implement a GDPR Quality System: A Practical Guide
A step-by-step guide for GDPR Responsible Persons on how to implement a GDPR QMS. From essential SOPs to supplier qualification and cold chain management.
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How to Create and Maintain an Inspection-Proof PSMF
Practical guide to managing the Pharmacovigilance System Master File (PSMF) according to GVP Module II. Structure, common errors, and operational checklist.
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Practical Guide to the CTD/eCTD Dossier: Drug Registration
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.
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WMS Validation in GDP: Data Integrity and Audit...
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.
WMS Validation in GDP: Data Integrity and Audit...
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.
PV Safety Database Validation: CSV, Annex 11, a...
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.
PV Safety Database Validation: CSV, Annex 11, a...
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.
CTIS and CTA in the EU: how to avoid RFIs and r...
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.
CTIS and CTA in the EU: how to avoid RFIs and r...
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.
GMP Supplier Qualification: Vendor Assurance fo...
Advanced guide to GMP supplier qualification and Quality Agreements: risk-based audits, change notification, CoA and skip testing, supplier KPIs, contractors and CMOs
GMP Supplier Qualification: Vendor Assurance fo...
Advanced guide to GMP supplier qualification and Quality Agreements: risk-based audits, change notification, CoA and skip testing, supplier KPIs, contractors and CMOs
SaaS GxP Change Control: Continuous Compliance ...
After go-live in the cloud, compliance is won through change control, incident management, periodic review and continuous audit preparation.
SaaS GxP Change Control: Continuous Compliance ...
After go-live in the cloud, compliance is won through change control, incident management, periodic review and continuous audit preparation.
GMP Inspection Readiness: QA Manager Pharma Pla...
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
GMP Inspection Readiness: QA Manager Pharma Pla...
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
