This course provides an in-depth understanding of microbiological practices in the pharmaceutical industry, emphasizing the latest advancements in rapid microbiological methods (RMM). Participants will explore various RMM technologies, learn about the differences between growth-based and non-growth-based methods, and gain insights into the validation and implementation of these innovative techniques. USP-NF General Chapters include the following:
• <72> Respiration-Based Microbiological Methods for the Detection of Contamination in Short-Life Products
• <73> ATP Bioluminescence-Based Microbiological Methods for the Detection of Contamination in Short-Life Products
• <1071> Rapid Microbiological Methods for the Detection of Contamination in Short-Life Products – A Risk-Based Approach

In addition to RMM, this course also contains two self-paced video modules on Sterility Testing and Bacterial Endotoxin Testing provided by Virtuosi. In Sterility Testing, you will learn why it is done in the laboratory, the materials, methods, and tools used for implementation, and how to interpret results.

Meanwhile, Bacterial Endotoxin Testing provides an overview of bacterial endotoxins and how they affect patients. It covers test methods and limitations, and suitability requirements, as well as methods for removal and destruction of pyrogens.

Subject area:
Drug Products & APIs

Objectives (If applicable):
– Implement new technologies that utilize rapid microbiological methods (RMM).
– Explain the differences between growth based and non-growth-based methods.
– Identify and develop validation criteria for RMM.

Target Audience (If applicable):
– QA/QC staff
– Regulatory affairs managers
– Scientists
– Microbiologists
– Investigators
– Other professionals who work or interact in a microbiology laboratory environment in pharmaceutical, biotech, excipients or allied industries.