Showing all 60 results
-
Aerosol Inhalers
PUF-1205An overview of the essential elements of aerosol inhalers, focusing on their purpose, key ingredients, benefits, limitations, typical… -
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… -
Aseptic Processing: Working with Biosafety Cabinets
ASP-1106Principles of working with biosafety cabinets focusing on the role of Class II BSCs in contamination prevention. It… -
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… -
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… -
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… -
Dosage Form Introduction
PUF-1201Explore the fundamentals of pharmaceutical dosage forms, including solids, liquids, aerosol inhalers, semisolids, and transdermal patches. Discover how… -
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,… -
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,… -
Filtration for Finished Dose
PEF-1204An overview of filtration in pharmaceutical manufacturing with a focus on the plate and frame filter press. Learn… -
Finished Dose Contamination Prevention
PGB-1203An overview of how contamination can threaten the safety and effectiveness of finished dose drug products. This module… -
Fluidized Beds
PEF-1206An overview of the fluidized bed granulation process, explaining its purpose, equipment, and the steps involved in forming… -
Four Level Serialization Structure
SER-1101Serialization and product tracking are essential tools in combating counterfeit drugs and ensuring patient safety within the pharmaceutical… -
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… -
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… -
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… -
Liquid Dosage Forms
PUF-1204An overview of the essential characteristics, production methods, and practical considerations of liquid dosage forms, including solutions and… -
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… -
Personnel and Training
PGI-1110An introduction to the roles, responsibilities, and regulatory requirements of personnel in pharmaceutical manufacturing environments. The module explains… -
Primary Packaging
PGI-1271An overview of primary packaging processes in pharmaceutical manufacturing, covering essential components such as container types, contamination prevention,… -
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… -
Secondary and Tertiary Packaging
PGI-1272An overview of the procedures and protocols involved in secondary and tertiary packaging in pharmaceutical manufacturing. This module… -
Semisolid Dosage Forms
PUF-1203An overview of semisolid dosage forms used in the pharmaceutical industry, including ointments, creams, gels, and pastes. Learners… -
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 – Aggregation and Error Management
SER-1104A detailed exploration of aggregation and disaggregation processes on a serialization packaging line, focusing on the parent-child relationships… -
Serialization – Exception Events, Disaggregation, and Reaggregation
SER-1105A comprehensive overview of the processes involved in exception events, disaggregation, and reaggregation within serialization systems on packaging… -
Serialization and Product Tracking
SER-1100An overview of serialization and product tracking technologies, focusing on their critical role in the pharmaceutical and biologics… -
Serialization and the Supply Chain
SER-1106An overview of the serialization and product tracking processes as they pertain to the pharmaceutical supply chain, focusing… -
Solid Dosage Forms
PUF-1202An introduction to the various types of pharmaceutical solid dosage forms, including tablets, capsules, and sachets. The module… -
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… -
Sterile Filtration
PST-1293An overview of sterile filtration in the pharmaceutical and biologics industries, explaining the principles and applications of this… -
Tablet Coater
PEF-1208An overview of the tablet coating process, explaining its purpose, equipment, and the steps involved in coating tablets.… -
Tablet Press
PEF-1207An introduction to the essential principles of tablet compression, focusing on the critical process of tablet formation, the… -
Warehousing
PGI-1220An overview of the essential functions of warehousing within pharmaceutical and biologics facilities, emphasizing its role in maintaining…
