Category: GLP

How to Prevent Data Integrity Violation in Pharma

How to Prevent Data Integrity Violation in Pharma

Data integrity, prevention of data integrity violation, data integrity and regulatory compliance, case studies and frequently asked question

Corrective and Preventive Action (CAPA): How to Implement

Corrective and Preventive Action (CAPA): How to Implement

Corrective and preventive Action (CAPA), CAPA implementation plan, purpose, elements, examples, case study, advantages and FAQs of CAPA

Good Documentation Practices: Quality Need

Good Documentation Practices: Quality Need

Good documentation practices, GDP, GDP definition, key components, principles, documentation management, regulatory requirements, 10Cs of the documentation

How to handle OOT and OOS

How to handle OOT and OOS

OOT and OOS, difference between OOS and OOT, case studies, management of OOS and OOT, out of specification and out of trend and FAQS

GLP IN PHARMACEUTICAL DEVELOPMENT

GLP IN PHARMACEUTICAL DEVELOPMENT

GLP, Good laboratory practices, key elements of GLP, DQ, IQ,OQ, PQ, 21 CFR, difference between GLP and GMP, interview questions on GLP

Why SOP is So Important in an Organization

Why SOP is So Important in an Organization

SOP, components of the SOP, types of SOP, standard operating procedure, advantage of SOP, interview questions on SOP, sop writing procedure

How to Perform Solutions Stability in AMV: Case Study

How to Perform Solutions Stability in AMV: Case Study

how to perform solutions stability of assay and related substances? case studies and interview questions on solution stability

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