Showing all 86 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… -
API Contamination Prevention
BGB-1203A comprehensive overview of the various types of contamination that can affect Active Pharmaceutical Ingredients (APIs) during production,… -
Aseptic Processing: Cleanrooms and Control Technologies
ASP-1102Cleanroom design, use, and operation in aseptic processing, and the role of associated contamination control technologies such as… -
Aseptic Processing: Contamination Control
ASP-1104Contamination prevention measures, procedures, and practices that are typically implemented in aseptic processing including the use of cleanrooms,… -
Aseptic Processing: Decontamination and Sterilization Technologies
ASP-1105Methods typically used to decontaminate and sterilize equipment, consumables, containers/closures, and products as part of aseptic processing. Methods… -
Aseptic Processing: Gowning
ASP-1103Gowning and its use in aseptic processing, including the different gowning requirements for different cleanroom classifications, the protective… -
ATMP Manufacturing – Cell and Gene Therapies
BMT-1161This Module is designed for personnel who require an overview of the nature and function of cell and… -
Basic Microbiological Techniques
PPM-1210An overview of essential microbiological techniques frequently performed in laboratory settings, emphasizing the preparation of different types of… -
Buildings & Facilities
PGI-1290An overview of the foundational principles of GMP-compliant pharmaceutical plant design, focusing on minimizing contamination risk through strategic… -
Cell Biology and Recombinant DNA Technology
BPU-1108Following on from BPU-1100, this Module goes a level deeper in its explanation of cell biology and how… -
Cell Culture in Biopharmaceutical Manufacturing
BPU-1107This Module is aimed at biopharmaceutical personnel who require a foundation knowledge of cell culture as part of… -
Centrifuges
PEA-1210An introduction to the theory and operation of centrifuges in API manufacturing, focusing on the principles behind batch… -
Chemical Laboratory Waste
PSY-1260A comprehensive guide to the categorization, storage, and safe disposal of chemical waste produced in pharmaceutical and laboratory… -
Chemical Reactions: Overview
PUA-1200An overview of chemical reactions in API (Active Pharmaceutical Ingredient) manufacturing, with a focus on controlling key process… -
Chemical Reactions: Properties
PUA-1201An in-depth look at the key physical and chemical properties that are critical for monitoring and controlling chemical… -
Chemical Reactor Design
PEA-1200An exploration of the design and operational principles of chemical reactors used in the production of Active Pharmaceutical… -
Cleaning of Equipment
PGI-1230An overview of essential cleaning practices for equipment in pharmaceutical and biologics manufacturing. This module explains the importance… -
Contamination Control Strategy – Annex 1 and QRM
CCS-1101Explains the ‘why’ behind Contamination Control Strategy (CCS) and Quality Risk Management (QRM) for all employees involved in… -
Contamination Control Strategy – QRM in Practice
CCS-1102Unlocks the ‘how’ of using Quality Risk Management (QRM) to successfully devise, implement, and maintain your facility’s Contamination… -
Crystallization
PUA-1220An introduction to the principles and techniques of crystallization used in API manufacturing. This module covers the formation… -
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… -
Distillation & Reflux
PUA-1210The principles of distillation and reflux, focusing on their roles in active pharmaceutical ingredient (API) manufacturing. Learners will… -
Downstream Processing: Ultrafiltration and Diafiltration
BPU-1102Describes the downstream manufacturing processes of ultrafiltration and diafiltration with an emphasis on post-harvest volume reduction and concentration… -
Dress Codes for APIs
BGB-1204A detailed guide to the importance and implementation of dress codes in Active Pharmaceutical Ingredient (API) manufacturing. It… -
Dress Codes for Finished Dosage Form Manufacturing
PGB-1204An overview of contamination prevention in finished dose pharmaceutical manufacturing, highlighting the types and sources of contamination—microbiological, physical,… -
Essentials of Biopharmaceutical Manufacturing
BMT-1102A practical overview of how biopharmaceuticals are manufactured—from cell thawing and culture in upstream processing, through separation, purification,… -
Executive Responsibility in Pharma Manufacturing
RGM-1200This module provides executive management in pharmaceutical manufacturing with a comprehensive understanding of their legal and regulatory responsibilities… -
Fermentation in Biopharmaceutical Manufacturing
BPU-1106Describes how microorganisms are used in fermentation processes as part of biopharmaceutical manufacturing. Areas covered include growth phases… -
Filtration
PUA-1240An introduction to the filtration process in API (Active Pharmaceutical Ingredient) manufacturing, covering the theory behind filtration, the… -
Finished Dose Contamination Prevention
PGB-1203An overview of how contamination can threaten the safety and effectiveness of finished dose drug products. This module… -
Fundamentals of Process Validation
PVF-1130An overview of process validation in regulated industries, such as pharmaceuticals, biopharmaceuticals, active pharmaceutical ingredients, and medical devices.… -
Gas Sterilization
PST-1295Ethylene oxide (ETO) use in gas sterilization, covering applications, process, equipment, and critical sterilization parameters. It also explores… -
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 – Execute and Monitor
CIR-1103Practical strategies for executing and monitoring a GCP inspection readiness project. This module focuses on the critical third… -
General Safety Hazards in the Microbiology Lab
PSY-1221Gain a comprehensive understanding of the critical safety hazards in a microbiology laboratory, from the handling of various… -
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 for Microbiology
PGM-1200Explore the critical application of Good Manufacturing Practices (GMP) within a microbiology laboratory setting. This comprehensive module covers… -
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… -
HPLC Troubleshooting
PPL-1131A comprehensive guide to efficiently diagnosing and resolving issues in High-Performance Liquid Chromatography (HPLC) systems. The module covers… -
HVAC and Cleanrooms
PST-1210Use of HVAC systems and HEPA filters in cleanroom environments. It covers the regulation of airflow, pressure, temperature,… -
Introduction to HPLC
PPL-1130Explore the fundamentals of High-Performance Liquid Chromatography (HPLC), the essential technique used in pharmaceutical quality control for the… -
Introduction to Microscopy
PPM-1211An essential overview of the role of microscopy in microbiology, this module details microscope components, lens systems, and… -
IT Use in Regulated Industries
GVC-1200Explore the critical role of Information Technology in the life sciences industry, from foundational concepts of IT systems… -
Laboratory Equipment Qualification
PVL-1200Gain a comprehensive understanding of laboratory equipment qualification, focusing on the critical stages that ensure accuracy, reliability, and… -
Laboratory GMP
PGL-1210Gain a comprehensive understanding of analytical laboratory Good Manufacturing Practice (GMP) requirements and their significance in maintaining the… -
Laboratory Safe Work Practices
PSY-1241An essential guide to ensuring safety in the chemical laboratory, focusing on the use of documented safety information… -
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… -
Out of Specification and Atypical Results
PGL-1200An in-depth look at Out of Specification (OOS) and Atypical results in pharmaceutical quality control. It examines the… -
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… -
Primary Packaging
PGI-1271An overview of primary packaging processes in pharmaceutical manufacturing, covering essential components such as container types, contamination prevention,… -
Principles of Good Aseptic Technique
PPM-1200The fundamentals of aseptic techniques are essential for microbiological testing in pharmaceutical and biologics environments. Learn how to… -
Process Flow Diagrams
PUA-1260An introduction to Process Flow Diagrams (PFDs) used in the pharmaceutical and chemical industries to visually represent processes… -
Process Validation: Process Design
BPU-1111An overview of the process design stage of process validation, describing how a biopharmaceutical manufacturing process can be… -
Process Validation: Process Qualification and Control
BPU-1112An overview of the qualification and continuing verification stages of process validation, intended to demonstrate that a biopharmaceutical… -
Reciprocating Pumps
PEA-1240An overview of reciprocating pumps, focusing on their functionality, types, and applications in chemical and pharmaceutical processing. It… -
Records in API Manufacturing
BGI-1101Effective record-keeping is a critical aspect of API manufacturing operations. This module introduces the essential records used in… -
Records in Finished Dosage Form Manufacturing
PGI-1101An overview of the essential role of records in Finished Dosage Form Manufacturing, focusing on their purpose, types,… -
Regulation of the Pharmaceutical Industry
PGB-1102Explore how the pharmaceutical industry is regulated across major global drug markets, focusing on key regulatory authorities, the… -
Rotary and Centrifugal Pumps
PEA-1241A focused exploration of rotary and centrifugal pumps, their operational principles, and their application in pharmaceutical processing. This… -
Secondary and Tertiary Packaging
PGI-1272An overview of the procedures and protocols involved in secondary and tertiary packaging in pharmaceutical manufacturing. This module… -
Serial Number Generation
SER-1102A comprehensive overview of the process for generating, storing, and assigning serial numbers to medicinal products, with a… -
Serial Number Transmission
SER-1103An in-depth exploration of the transmission of serial numbers through the four-level serialization structure, from the enterprise level… -
Serialization and the Supply Chain
SER-1106An overview of the serialization and product tracking processes as they pertain to the pharmaceutical supply chain, focusing… -
SOPs in API Manufacturing
BGI-1100Explores the essential role of Standard Operating Procedures (SOPs) in Active Pharmaceutical Ingredient (API) manufacturing. It focuses on… -
SOPs in Finished Dosage Form Manufacturing
PGI-1100An overview of the critical role of Standard Operating Procedures (SOPs) in Finished Dosage Form Manufacturing. This module… -
Understanding Dissolution
PPL-1210Explore the fundamentals of dissolution testing and its critical role in the pharmaceutical industry. This module provides a… -
Unknown Bacterial Identification
PPM-1230Dive into the essential methods for identifying unknown bacterial contaminants within pharmaceutical and biologics laboratories. This module covers… -
Warehousing
PGI-1220An overview of the essential functions of warehousing within pharmaceutical and biologics facilities, emphasizing its role in maintaining… -
Water Impurities & Treatment
PUA-1251An essential guide to understanding the various impurities found in water used in pharmaceutical manufacturing. It covers the… -
Working with Reactors
PEA-1201The key processes involved in the operation of reactors, including proper techniques for weighing, charging, and taking samples.…
