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.
ARTICLES & INSIGHTS
Useful knowledge for your professional journey.
Roles, quality systems, operational activities and regulatory topics explained with a practical approach.
Pharma Roles & Careers
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.
A Practical Guide to Deviations and CAPA: GMP M...
Learn how to manage deviations, investigations (root cause analysis), and CAPA (corrective actions) according to GMP. A practical guide for QA.
A Practical Guide to Deviations and CAPA: GMP M...
Learn how to manage deviations, investigations (root cause analysis), and CAPA (corrective actions) according to GMP. A practical guide for QA.
QP Batch Release and Certification: EU GMP Anne...
Step-by-step guide to batch release according to EU GMP Annex 16. The document checklist and management of deviations for QP.
QP Batch Release and Certification: EU GMP Anne...
Step-by-step guide to batch release according to EU GMP Annex 16. The document checklist and management of deviations for QP.
