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.
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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.
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...
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Who is the GDP Responsible Person? Role and Regulations Explained
Find out who the GDP Responsible Person (RP) is according to the GDP regulation. Analysis of responsibilities, differences between GMP and QP, and qualification requirements.
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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.
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What Are Regulatory Affairs (RA)? A Guide to the Pharma Role
Discover what Regulatory Affairs (RA) professionals do in the pharmaceutical industry: from the CTD registration dossier to regulatory strategy with EMA and FDA.
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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.
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Who is a Qualified Person (QP)? A Guide to the Role and Legal Requirements
Find out who the pharmaceutical Qualified Person (QP) is, their legal responsibilities (Directive 2001/83) and the requirements (degree, experience) to become one.
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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
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.
Practical Guide to the CTD/eCTD Dossier: Drug R...
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.
Practical Guide to the CTD/eCTD Dossier: Drug R...
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.
