Pharma Roles & Careers
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...
GMP Department Management: Data Integrity, BPR ...
A practical guide for manufacturing managers: how to manage batch records (BPR), apply data integrity (ALCOA+), and supervise validations (IQ/OQ/PQ).
GMP Department Management: Data Integrity, BPR ...
A practical guide for manufacturing managers: how to manage batch records (BPR), apply data integrity (ALCOA+), and supervise validations (IQ/OQ/PQ).
How to Implement a GDPR Quality System: A Pract...
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.
How to Implement a GDPR Quality System: A Pract...
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.
How to Create and Maintain an Inspection-Proof ...
Practical guide to managing the Pharmacovigilance System Master File (PSMF) according to GVP Module II. Structure, common errors, and operational checklist.
How to Create and Maintain an Inspection-Proof ...
Practical guide to managing the Pharmacovigilance System Master File (PSMF) according to GVP Module II. Structure, common errors, and operational checklist.