Showing all 52 results
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API Contamination Prevention
BGB-1203A comprehensive overview of the various types of contamination that can affect Active Pharmaceutical Ingredients (APIs) during production,… -
Aseptic Processing – Working with Closed Isolators
ASP-1107A detailed look at the use of closed isolators in aseptic processing of sterile products, covering their design,… -
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: Concepts and Controls
ASP-1101Aseptic processing concepts and associated technologies and techniques used for contamination control and prevention, including procedures to minimize… -
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: Essential Personnel Practices
ASP-1108In depth exploration of essential personnel practices in aseptic processing, presented through the manufacturing journey of a fictional… -
Aseptic Processing: Gowning
ASP-1103Gowning and its use in aseptic processing, including the different gowning requirements for different cleanroom classifications, the protective… -
Buildings & Facilities
PGI-1290An overview of the foundational principles of GMP-compliant pharmaceutical plant design, focusing on minimizing contamination risk through strategic… -
CAPA for Nonconformities
OPE-1101A thorough exploration of Corrective Actions and Preventive Actions (CAPA) as they apply to quality management in GxP-regulated… -
Centrifuges
PEA-1210An introduction to the theory and operation of centrifuges in API manufacturing, focusing on the principles behind batch… -
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… -
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… -
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… -
Dress Codes for APIs
BGB-1204A detailed guide to the importance and implementation of dress codes in Active Pharmaceutical Ingredient (API) manufacturing. It… -
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… -
Filtration
PUA-1240An introduction to the filtration process in API (Active Pharmaceutical Ingredient) manufacturing, covering the theory behind filtration, the… -
Gas Sterilization
PST-1295Ethylene oxide (ETO) use in gas sterilization, covering applications, process, equipment, and critical sterilization parameters. It also explores… -
GMP for APIs
BGB-1101Explores the foundations of Good Manufacturing Practices (GMP) in Active Pharmaceutical Ingredient (API) manufacturing, covering its historical development,… -
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… -
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… -
HVAC and Cleanrooms
PST-1210Use of HVAC systems and HEPA filters in cleanroom environments. It covers the regulation of airflow, pressure, temperature,… -
IT Use in Regulated Industries
GVC-1200Explore the critical role of Information Technology in the life sciences industry, from foundational concepts of IT systems… -
Moist Heat Sterilization
PST-1291An introduction to the principles and practices of moist heat sterilization using autoclaves. This module explains the science… -
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… -
Overview of Pharmaceutical Manufacturing
PGB-1100An overview of the foundational principles of pharmaceutical manufacturing, covering the different types of pharmaceutical products and the… -
Process Flow Diagrams
PUA-1260An introduction to Process Flow Diagrams (PFDs) used in the pharmaceutical and chemical industries to visually represent processes… -
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… -
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… -
SOPs in API Manufacturing
BGI-1100Explores the essential role of Standard Operating Procedures (SOPs) in Active Pharmaceutical Ingredient (API) manufacturing. It focuses on… -
Sterile Filtration
PST-1293An overview of sterile filtration in the pharmaceutical and biologics industries, explaining the principles and applications of this… -
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… -
Water Types and Testing
PUA-1250An overview of the different grades of water used in pharmaceutical manufacturing, including Potable Water, Purified Water, and… -
Working with Reactors
PEA-1201The key processes involved in the operation of reactors, including proper techniques for weighing, charging, and taking samples.…
