GXP ACADEMY · PHARMA ROLES & CAREERS
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
Roles, quality systems, operational activities and regulatory topics explained with a practical approach.
The GDP Responsible Person job description: the 12 duties under chapter 2.2 of the EU GDP Guidelines (2013/C 343/01), national requirements in Italy and Germany, and a section-by-section...
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Annex 16 unexpected deviations allow the QP to certify a batch under strict conditions. A practical guide to section 3: conditions, limits, the decision process and audit-ready documentation.
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The COFEPRIS sanitary verification visit step by step: legal basis, verification order, the acta, the rights of the inspected party and the 5-day window. With a practical checklist...
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How to get into regulatory affairs: an updated guide to the full pathway — science degrees, RAC/TOPRA certifications, real entry-level regulatory affairs jobs and the skills employers want,...
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How much does the fachtechnisch verantwortliche Person (FvP) earn in Switzerland? Updated version of the FvP guide covering the Swissmedic requirements (MedO/AMBV, I-SMI.TI.17) and the real salary figures...
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Updated guide to the validation master plan: annotated template, a practical example of scope and Validation Master List, EU GMP Annex 15 requirements and the changes brought by...
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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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How to become a Qualified Person (QP) in the pharmaceutical industry: the requirements of Directive 2001/83/EC, eligible degrees and minimum practical experience. From the QC lab to national...
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The GDP Responsible Person job description: the 12 duties under chapter 2.2 of the EU GDP Guidelines (2013/C 343/01), national requirements in Italy and Germany, and a section-by-section template for...
The GDP Responsible Person job description: the 12 duties under chapter 2.2 of the EU GDP Guidelines (2013/C 343/01), national requirements in Italy and Germany, and a section-by-section template for...
Annex 16 unexpected deviations allow the QP to certify a batch under strict conditions. A practical guide to section 3: conditions, limits, the decision process and audit-ready documentation.
Annex 16 unexpected deviations allow the QP to certify a batch under strict conditions. A practical guide to section 3: conditions, limits, the decision process and audit-ready documentation.
The COFEPRIS sanitary verification visit step by step: legal basis, verification order, the acta, the rights of the inspected party and the 5-day window. With a practical checklist to be...
The COFEPRIS sanitary verification visit step by step: legal basis, verification order, the acta, the rights of the inspected party and the 5-day window. With a practical checklist to be...
How to get into regulatory affairs: an updated guide to the full pathway — science degrees, RAC/TOPRA certifications, real entry-level regulatory affairs jobs and the skills employers want, with the...
How to get into regulatory affairs: an updated guide to the full pathway — science degrees, RAC/TOPRA certifications, real entry-level regulatory affairs jobs and the skills employers want, with the...
How much does the fachtechnisch verantwortliche Person (FvP) earn in Switzerland? Updated version of the FvP guide covering the Swissmedic requirements (MedO/AMBV, I-SMI.TI.17) and the real salary figures for pharmacists,...
How much does the fachtechnisch verantwortliche Person (FvP) earn in Switzerland? Updated version of the FvP guide covering the Swissmedic requirements (MedO/AMBV, I-SMI.TI.17) and the real salary figures for pharmacists,...
Updated guide to the validation master plan: annotated template, a practical example of scope and Validation Master List, EU GMP Annex 15 requirements and the changes brought by PIC/S PI...
Updated guide to the validation master plan: annotated template, a practical example of scope and Validation Master List, EU GMP Annex 15 requirements and the changes brought by PIC/S PI...
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