How to Become a Qualified Person in Germany (§ 14 AMG)
The Sachkundige Person is Germany's Qualified Person under § 14 AMG. Here is how to become a Qualified Person in Germany: education and experience requirements under § 15...
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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.
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Roles, quality systems, operational activities and regulatory topics explained with a practical approach.
Pharmaceutical Quality Assurance Salary: the Real Figures
What is a realistic pharmaceutical quality assurance salary in Italy? Real QA salary figures by experience level, the minimums set by the 2025-2028 chemical-pharmaceutical collective agreement, and the...
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Responsible Person (FvP) in Switzerland: Swissmedic Guide
The fachtechnisch verantwortliche Person (FvP) is the Responsible Person required by Swissmedic for manufacturing, importation and wholesale of medicinal products in Switzerland. MPLO requirements, education, experience, presence and...
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How to Get Into Pharmaceutical Quality Assurance
How to get into quality assurance in the pharmaceutical industry: starting degrees, the GMP skills that matter, entry-level roles and the career path up to QA Manager and...
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FDA/EMA Audit: Extractables & Leachables Documentation
How to build an audit-ready E&L dossier: documentation structure, risk assessment template, inspection checklist and answers to typical questions.
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Annex 1 and Single-Use Systems: Extractables & Leachables
How to implement Annex 1 §8.136 on E&L in single-use systems: risk-based strategy, supplier data, gap analysis, documentation and audit readiness.
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Validation Master Plan (VMP): Template According to Annex 15
Complete guide to the VMP: why it is a governance document, what it must contain according to Annex 15, how to define scope and attachments, with a practical...
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Data Integrity in Calibrations: ALCOA+, Audit Trail, and Part 11
Calibration certificates and logbooks: how to avoid uncontrolled Excel files, ensure ALCOA+, and implement CMMS/Part 11 systems without findings.
Read the article →Pharma Roles & Careers
How to Become a Qualified Person in Germany (§ ...
The Sachkundige Person is Germany's Qualified Person under § 14 AMG. Here is how to become a Qualified Person in Germany: education and experience requirements under § 15 AMG, appointment...
How to Become a Qualified Person in Germany (§ ...
The Sachkundige Person is Germany's Qualified Person under § 14 AMG. Here is how to become a Qualified Person in Germany: education and experience requirements under § 15 AMG, appointment...
Pharmaceutical Quality Assurance Salary: the Re...
What is a realistic pharmaceutical quality assurance salary in Italy? Real QA salary figures by experience level, the minimums set by the 2025-2028 chemical-pharmaceutical collective agreement, and the factors that...
Pharmaceutical Quality Assurance Salary: the Re...
What is a realistic pharmaceutical quality assurance salary in Italy? Real QA salary figures by experience level, the minimums set by the 2025-2028 chemical-pharmaceutical collective agreement, and the factors that...
Responsible Person (FvP) in Switzerland: Swissm...
The fachtechnisch verantwortliche Person (FvP) is the Responsible Person required by Swissmedic for manufacturing, importation and wholesale of medicinal products in Switzerland. MPLO requirements, education, experience, presence and batch release...
Responsible Person (FvP) in Switzerland: Swissm...
The fachtechnisch verantwortliche Person (FvP) is the Responsible Person required by Swissmedic for manufacturing, importation and wholesale of medicinal products in Switzerland. MPLO requirements, education, experience, presence and batch release...
How to Get Into Pharmaceutical Quality Assurance
How to get into quality assurance in the pharmaceutical industry: starting degrees, the GMP skills that matter, entry-level roles and the career path up to QA Manager and Qualified Person,...
How to Get Into Pharmaceutical Quality Assurance
How to get into quality assurance in the pharmaceutical industry: starting degrees, the GMP skills that matter, entry-level roles and the career path up to QA Manager and Qualified Person,...
FDA/EMA Audit: Extractables & Leachables Docume...
How to build an audit-ready E&L dossier: documentation structure, risk assessment template, inspection checklist and answers to typical questions.
FDA/EMA Audit: Extractables & Leachables Docume...
How to build an audit-ready E&L dossier: documentation structure, risk assessment template, inspection checklist and answers to typical questions.
Annex 1 and Single-Use Systems: Extractables & ...
How to implement Annex 1 §8.136 on E&L in single-use systems: risk-based strategy, supplier data, gap analysis, documentation and audit readiness.
Annex 1 and Single-Use Systems: Extractables & ...
How to implement Annex 1 §8.136 on E&L in single-use systems: risk-based strategy, supplier data, gap analysis, documentation and audit readiness.
