Showing all 25 results
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Anatomy of a Clinical Trial
CTM-1102An overview of the clinical trial process, from planning through closeout, this module delves into the design and… -
CAPA for Nonconformities
OPE-1101A thorough exploration of Corrective Actions and Preventive Actions (CAPA) as they apply to quality management in GxP-regulated… -
Errors in GMP Regulated Manufacturing
OPE-1103A comprehensive look at errors in GMP-regulated environments, examining the types of errors that occur, their root causes,… -
Executive Responsibility in Pharma Manufacturing
RGM-1200This module provides executive management in pharmaceutical manufacturing with a comprehensive understanding of their legal and regulatory responsibilities… -
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… -
GLP – An Introduction
PGL-1220Provides personnel with a foundational understanding of Good Laboratory Practice (GLP), focusing on its significance in nonclinical laboratory… -
GLP – Working in the Laboratory
PGL-1221Gain a comprehensive understanding of Good Laboratory Practice (GLP) and its critical role in nonclinical studies. This module… -
GMP for APIs
BGB-1101Explores the foundations of Good Manufacturing Practices (GMP) in Active Pharmaceutical Ingredient (API) manufacturing, covering its historical development,… -
GMP for Finished Dose Forms
PGB-1101A foundational exploration of Good Manufacturing Practices (GMP) in the pharmaceutical industry, focusing on the historical events that… -
GMP Inspection Readiness – Interacting with the Inspector
OPE-1102Essential knowledge and techniques for effective interaction with inspectors during a GMP inspection. This module covers the inspection… -
Laboratory GMP
PGL-1210Gain a comprehensive understanding of analytical laboratory Good Manufacturing Practice (GMP) requirements and their significance in maintaining the… -
Method Validation Parameters
PVL-1210A comprehensive examination of the key parameters in analytical method validation, crucial for ensuring the accuracy and reliability… -
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… -
Personnel and Training
PGI-1110An introduction to the roles, responsibilities, and regulatory requirements of personnel in pharmaceutical manufacturing environments. The module explains… -
Records in API Manufacturing
BGI-1101Effective record-keeping is a critical aspect of API manufacturing operations. This module introduces the essential records used in… -
Regulation of the Pharmaceutical Industry
PGB-1102Explore how the pharmaceutical industry is regulated across major global drug markets, focusing on key regulatory authorities, the… -
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… -
SOPs in API Manufacturing
BGI-1100Explores the essential role of Standard Operating Procedures (SOPs) in Active Pharmaceutical Ingredient (API) manufacturing. It focuses on…
