- Cost: $99.00
The development and manufacturing of potent compounds in the pharmaceutical industry has increased significantly over the past several years. To address safety issues with containing novel potent compounds, drug manufacturers have used categorization (control banding) techniques to guide safe handling. This course provides an introduction to potent compounds, categorization systems, and design for containment of potent compounds.
Topics include: introduction, categorization systems, general guidelines for facility and equipment design for containment, consideration of particular containment systems (i.e., isolators, booths, rapid transfer ports, etc.).
- Cost: $99.00Facility design is a complex process involving thousands of decisions that must be addressed in a systematic manner. Biopharm manufacturing facility designs add complexity of additional regulatory and sanitary requirements. This course overviews the different phases of facility design and focuses on the Programming Phase (first phase) of facility design.Topics include: basic terminology, design phases overview, programming phase details including project scope definition, program criteria definition, and addressing technology challenges and innovations.Prerequisite: none.
- Cost: $99.00
Biopharmaceutical manufacturing is a very intensive, knowledge-based, regulated industry. New hires and existing employees require significant training in order to upgrade and maintain their skills and expertise. This online course will help prepare the learner for the challenges and opportunities that lie ahead in Biopharm Manufacturing.
The following topics are introduced: basic terminology, usage of regulations and standards, application of modern biology to biopharm manufacturing, overview of operations, support areas and critical utilities in a biopharm plant, and the importance of clean and sanitary processing.
- Cost: $99.00
Clean in Place (CIP) is a recognized method for automatically cleaning process piping and equipment without manually dismantling the components prior to cleaning. This online course provides an introduction to the history, standard components, hygienic design, and typical operations of CIP systems using basic schematics and other interactions to convey information.
The following topics are discussed: basic terminology and history of CIP, advantages and disadvantages of cleaning in place, CIP system typical components, operations, and cleaning steps, basic hygienic design, and an introduction to CIP validation.
Course Attachments: CIP typical cleaning steps table.
The biopharmaceutical industry uses biological agents to make their products. Some of these agents may be infectious or genetically modified and may pose a serious health risk to workers if they are exposed to the agents. This online course focuses on the different Biosafety Levels and the precautions that can be taken to protect employees and contractors that work in biopharm facilities.
The following topics are introduced: routes of exposure, biosafety levels, risk assessment, procedures, labeling, containment, decontamination and sanitization, spill reporting and clean-up, personal protective equipment (PPE), waste handling and disposal.