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The Pharmaceutical Manufacturing Manager: Role ...
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 regulations.
The Pharmaceutical Manufacturing Manager: Role ...
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 regulations.
Who is the GDPR Responsible Person? Role and Re...
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.
Who is the GDPR Responsible Person? Role and Re...
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.
Who is the QPPV? A Guide to the Role of the Pha...
Discover who the QPPV (Qualified Person for Pharmacovigilance) is, their responsibilities (GVP, PSMF), and why this role is crucial for EMA and AIFA compliance.
Who is the QPPV? A Guide to the Role of the Pha...
Discover who the QPPV (Qualified Person for Pharmacovigilance) is, their responsibilities (GVP, PSMF), and why this role is crucial for EMA and AIFA compliance.
What Are Regulatory Affairs (RA)? A Guide to th...
Discover what Regulatory Affairs (RA) professionals do in the pharmaceutical industry: from the CTD registration dossier to regulatory strategy with EMA and FDA.
What Are Regulatory Affairs (RA)? A Guide to th...
Discover what Regulatory Affairs (RA) professionals do in the pharmaceutical industry: from the CTD registration dossier to regulatory strategy with EMA and FDA.
Who is the QA Manager? A Guide to the Role in P...
Discover what a Pharmaceutical QA Manager does: management of the PQS (ICH Q10), GMP compliance, and oversight of deviations, CAPAs, and internal audits.
Who is the QA Manager? A Guide to the Role in P...
Discover what a Pharmaceutical QA Manager does: management of the PQS (ICH Q10), GMP compliance, and oversight of deviations, CAPAs, and internal audits.
Who is a Qualified Person (QP)? A Guide to the ...
Find out who the pharmaceutical Qualified Person (QP) is, their legal responsibilities (Directive 2001/83) and the requirements (degree, experience) to become one.
Who is a Qualified Person (QP)? A Guide to the ...
Find out who the pharmaceutical Qualified Person (QP) is, their legal responsibilities (Directive 2001/83) and the requirements (degree, experience) to become one.