Showing all 16 results
-
Anatomy of a Clinical Trial
CTM-1102An overview of the clinical trial process, from planning through closeout, this module delves into the design and… -
Data Integrity – GxP Audit Trail Requirements
DTI-1102An exploration of the essential components of audit trails within GxP-regulated environments, this module covers the definition, purpose,… -
Data Integrity for GxP Regulated Industries
DTI-1101A comprehensive examination of the importance of data integrity in GxP-regulated industries, focusing on the critical role data… -
GCP Essential Documents: Investigators Brochure & Study Protocol
CTM-1202An overview of two key documents used in a clinical trial – the Investigator’s Brochure and the Study… -
GCP Inspection Readiness – Close
CIR-1104Explore the critical tasks and best practices for concluding a GCP inspection readiness project. This module guides learners… -
GCP Inspection Readiness – Initiate
CIR-1101An overview of a project management approach to preparation for a GCP regulatory inspection, with a focus on… -
GCP Inspection Readiness – Plan
CIR-1102A comprehensive guide to planning an inspection readiness project for GCP compliance. This module covers the essential tasks… -
GCP Inspection Readiness – Execute and Monitor
CIR-1103Practical strategies for executing and monitoring a GCP inspection readiness project. This module focuses on the critical third… -
GxP Computerized Systems Validation
CSV-1101An overview of the critical concepts and key requirements of Computerized Systems Validation (CSV) in regulated life sciences… -
GxP Good Documentation Practices – Applications
GXP-1102The critical importance of Good Documentation Practices (GDocP) in GxP-regulated industries, focusing on the application of ALCOA+ principles… -
GxP Good Documentation Practices – Principles
GXP-1101Essential principles of Good Documentation Practices (GDocP) for GxP-regulated industries, emphasizing data integrity and the ALCOA+ framework. The… -
IT Use in Regulated Industries
GVC-1200Explore the critical role of Information Technology in the life sciences industry, from foundational concepts of IT systems… -
New Drug Development and Clinical Trials
CTM-1100An essential overview of the drug development process, guiding learners through the stages from initial research to regulatory… -
Overview of 21 CFR Part 11
GVC-1202Gain a clear understanding of the FDA's 21 CFR Part 11 regulation, which governs the use of electronic… -
Overview of GxP
GXP-1200The essential principles and regulations of Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice… -
Roles and Responsibilities under ICH GCP
CTM-1101An exploration of the principles and guidelines outlined in ICH Good Clinical Practice (GCP), focusing on the ethical…
