Pharma Roles & Careers
GDP Audits: How to Pass AIFA Inspections (RP Gu...
Prepare for a GDP audit. Learn about the most common non-compliances detected by AIFA and NAS, and the audit readiness checklist for GDPR Responsible Persons.
GDP Audits: How to Pass AIFA Inspections (RP Gu...
Prepare for a GDP audit. Learn about the most common non-compliances detected by AIFA and NAS, and the audit readiness checklist for GDPR Responsible Persons.
GVP Audits and Pharmacovigilance Inspections: A...
Prepare for a GVP inspection (EMA/AIFA). Find out what inspectors are looking for in your pharmacovigilance system, from PSMF to signal management.
GVP Audits and Pharmacovigilance Inspections: A...
Prepare for a GVP inspection (EMA/AIFA). Find out what inspectors are looking for in your pharmacovigilance system, from PSMF to signal management.
Pharmaceutical Regulatory Compliance: A Guide t...
Prepare for EMA/FDA inspections. A guide to regulatory compliance in Pharmacovigilance (RMP, PSUR) and Labeling (QRD) for RA professionals.
Pharmaceutical Regulatory Compliance: A Guide t...
Prepare for EMA/FDA inspections. A guide to regulatory compliance in Pharmacovigilance (RMP, PSUR) and Labeling (QRD) for RA professionals.
Data Integrity (ALCOA+): Audit-Readiness Guide ...
Ensures Data Integrity (ALCOA+) and compliance with EU GMP Annex 11. QA Guide for Computerized Systems Validation (CSV).
Data Integrity (ALCOA+): Audit-Readiness Guide ...
Ensures Data Integrity (ALCOA+) and compliance with EU GMP Annex 11. QA Guide for Computerized Systems Validation (CSV).
QP and Drug Importation: Managing Risk and the ...
Guide for QPs on importing pharmaceuticals from third countries (China, India) and outsourcing (CMO). MRA management, audits, Annex 16, and responsibilities.
QP and Drug Importation: Managing Risk and the ...
Guide for QPs on importing pharmaceuticals from third countries (China, India) and outsourcing (CMO). MRA management, audits, Annex 16, and responsibilities.
Out of Tolerance (OOT) Management: A 6-Step Pra...
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 batches, and...
Out of Tolerance (OOT) Management: A 6-Step Pra...
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 batches, and...