Showing all 58 results
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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… -
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… -
Bioprocessing using Single-Use Technologies
BMT-1142This Module is aimed at biopharmaceutical personnel who require a foundational knowledge of single-use systems and how they… -
Bioreactors in Bioprocessing
BPU-1104Describes the function, design, set-up and control of bioreactors in the biopharmaceutical industry. It examines control parameters such… -
Biotechnology for Biopharmaceutical Manufacturing
BMT-1101An exploration of the science and technology behind biopharmaceuticals, from foundational techniques like recombinant DNA technology to advanced… -
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… -
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… -
Clean in Place
BPU-1101Explains key concepts of Clean In Place (CIP) technology commonly used in the biotechnology and pharmaceutical industries. It… -
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… -
Downstream Processing: Centrifugation
BPU-1103Describes what centrifugation is and the stages of biopharmaceutical downstream processing where it can be used. Primary cell… -
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… -
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,… -
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… -
Formulation & Packaging in the Biopharmaceutical Industry
BPU-1109Provides an overview of the principles and practices of formulation and packaging processes in a modern biopharmaceutical manufacturing… -
Four Level Serialization Structure
SER-1101Serialization and product tracking are essential tools in combating counterfeit drugs and ensuring patient safety within the pharmaceutical… -
Freeze Drying in Biopharmaceutical Manufacturing
BPU-1113Describes freeze drying (lyophilization), its use in biopharmaceutical manufacturing, the structure of a freeze dryer and the freeze… -
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… -
Primary Packaging
PGI-1271An overview of primary packaging processes in pharmaceutical manufacturing, covering essential components such as container types, contamination prevention,… -
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… -
Protein Purification in Downstream Processing
BPU-1110Describes the use of various chromatographic methods in downstream protein purification including size exclusion, ion exchange, hydrophobic interaction… -
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… -
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… -
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 Single-Use Bioreactors
BMT-1112A practical introduction to the key operator tasks involved in working with single-use bioreactors (SUBs) in modern biopharmaceutical…
