Pharmaceutical Product Lifecycle Management

Overview The " Data Integrity and 21 CFR Part 11" section of the GAMP ® Basic Principles (T45) training course provides a comprehensive overview of regulatory expectations for data integrity, electronic records, and electronic signatures in GxP environments. Drawing from FDA guidance, MHRA definitions, and the ISPE GAMP® Records and Data Integrity Guide, the module emphasizes the importance of complete, consistent, and accurate data throughout its lifecycle. Participants explore the scope and application of Part 11, and topics including predicate rules, audit trails, access controls, authority…

Overview The " Testing of GxP Computerized Systems" section of the GAMP ® Basic Principles (T45) training course provides a comprehensive overview of testing strategies across the system lifecycle, emphasizing defect detection, risk management, and fitness for intended use. Participants explore both traditional and modern testing approaches, including scripted, unscripted, exploratory, and automated testing, with guidance on selecting the most appropriate method based on system impact and risk, the testing objective, and the nature of the component under test. The section highlights the…

Overview TThe " Quality Risk Management (QRM)" section of the GAMP ® Basic Principles (T45) training course provides a structured, science-based approach to identifying, assessing, and controlling risks throughout the lifecycle of GxP computerized systems. Grounded in ICH Q9 R1 principles, the module emphasizes risk to patient safety, product quality, and data integrity, while also considering business impact. Participants learn to apply a five-step QRM process from initial system impact assessment to ongoing monitoring of controls using approaches that evaluate hazards for severity…

Overview The " GAMP® 5 – Life Cycle in Detail" section of the GAMP ® Basic Principles (T45) training course offers an in-depth exploration of the system life cycle phases Concept, Project, Operational, and Retirement within the context of GxP computerized systems. Emphasizing a risk-based, scalable approach, the module guides learners through key activities, including requirements definition, specification, verification, and traceability. It introduces software and hardware categorization to tailor validation efforts based on complexity, novelty, and risk, and aligns with modern development…

The Pharmaceutical Quality System (PQS), as defined by ICH Q10, ensures product quality and continuous improvement throughout the lifecycle of pharmaceutical products. Overview This fundamental online course introduces the Pharmaceutical Quality System (PQS), which is a framework that ensures product quality meets established standards throughout the lifecycle of pharmaceutical products. It aims for suitable process performance by implementing robust controls for drug development and manufacturing, including quality assurance, risk management, and regulatory compliance. The system identifies…