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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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.
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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A Practical Guide to Deviations and CAPA: GMP Management for QA
Learn how to manage deviations, investigations (root cause analysis), and CAPA (corrective actions) according to GMP. A practical guide for QA.
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QP Batch Release and Certification: EU GMP Annex 16 Guide
Step-by-step guide to batch release according to EU GMP Annex 16. The document checklist and management of deviations for QP.
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VMP and Calibration Plan: A Guide to a No-Fault...
Prepare for your GMP audit. How to defend the Validation Master Plan (VMP) and Calibration Plan. Common mistakes and inspector expectations (FDA/EMA).
VMP and Calibration Plan: A Guide to a No-Fault...
Prepare for your GMP audit. How to defend the Validation Master Plan (VMP) and Calibration Plan. Common mistakes and inspector expectations (FDA/EMA).
GMP Audits in Production: How to Avoid FDA/AIFA...
Prepare for a GMP inspection (FDA, AIFA, EMA). Analysis of the most common production findings (483), data integrity, Annex 1, and audit readiness checklist.
GMP Audits in Production: How to Avoid FDA/AIFA...
Prepare for a GMP inspection (FDA, AIFA, EMA). Analysis of the most common production findings (483), data integrity, Annex 1, and audit readiness checklist.
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).
