Course Description:
Rapid microbiological methods (RMM), also referred to as alternative microbiological methods (AMM), are transforming microbial testing by reducing time-to-result and enabling faster, more informed decisions in pharmaceutical manufacturing and compounding. As advanced therapeutics, biologics, and short shelf-life products continue to grow in demand, so does the need for rapid, precise and reliable microbial detection.
In this webinar, experts from the United States Pharmacopeia (USP) and the Parenteral Drug Association (PDA) will explore the evolving framework of standards and guidance that support rapid microbiological method adoption. The session will begin by introducing the upcoming release of USP <77>, which provides guidance for nucleic acid amplification testing for Mycoplasma.
Building on this new chapter, the discussion will highlight compendial guidance supporting rapid and alternative microbiological technologies, including USP chapters <72>, <73>, and <1071>, which address sterility testing of short shelf-life products. Attendees will also receive an update on the highly anticipated revision of PDA Technical Report 33, including practical industry experience, statistical approaches for evaluating rapid method performance, and considerations for applying these technologies across laboratory and operational environments.
Taken together, these USP chapters and PDA guidance documents create a complementary framework for adopting rapid microbiological technologies. By combining compendial expectations with practical industry guidance, experts will provide organizations with a clear path for validation, suitability testing, and risk-based implementation while strengthening contamination control strategies.
Topics:
- Describe how rapid microbiological methods improve time-to-results and quality decisions.
- Identify key updates from USP chapters <72>, <73>, <77>, and <1071>.
- Summarize the role of the revised PDA Technical Report 33 in implementing rapid methods.
- Recognize combined validation and suitability considerations for adopting rapid microbiological technologies.
Who should participate:
- QC Staff
- QA Staff
- Sterility assurance and contamination control specialists
- Microbiology laboratory scientists and managers
- Manufacturing and operations professionals in aseptic or sterile production
- Regulatory
Access Duration:
Access to this course expires 6 months from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.