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.
Read the article →GXP ACADEMY · PHARMA ROLES & CAREERS
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.
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.
Read the article →
Validation vs. Calibration Manager: Why are they distinct roles?
Discover the responsibilities of the Validation Manager (VMP, IQ/OQ/PQ) and the Calibration Manager (Calibration, OOT) in Pharma and why their integration is vital.
Read the article →
The Pharmaceutical Manufacturing Manager: Role and GMP Standards
Who is a Manufacturing Manager in the GMP context? An analysis of responsibilities, differences between QA and QP, and the impact of EU GMP, FDA, and ICH Q10...
Read the article →
Who is the QPPV? A Guide to the Role of the Pharmacovigilance Responsible Person
Discover who the QPPV (Qualified Person for Pharmacovigilance) is, their responsibilities (GVP, PSMF), and why this role is crucial for EMA and AIFA compliance.
Read the article →
Who is the QA Manager? A Guide to the Role in Pharmaceutical Quality Assurance
Discover what a Pharmaceutical QA Manager does: management of the PQS (ICH Q10), GMP compliance, and oversight of deviations, CAPAs, and internal audits.
Read the article →
Qualified Person: Legal Responsibilities and Professional Defense
Batch release is the legal responsibility of the Qualified Person (QP). Discover the main obligations and how our guides can support you with defensive checklists and real-world cases.
Read the article →Pharma Roles & Careers
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.
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...
