Implementing automated microbiological methods requires a robust validation strategy to show that a system is suitable for its intended use. The strategy must be defensible to regulators while also being practical and achievable within a reasonable timeframe.
This webinar will cover the validation requirements and principles in European Pharmacopoeia 5.1.6, USP <1223>, PDA Technical Report No. 33 and related industry guidance, with a focus on accuracy, precision, Time to Results (TTR), equivalence and method suitability.
The webinar will then walk through the validation strategy used to implement the Growth Direct® System, an automated platform that runs compendial methods using agar-filled cassettes for Environmental Monitoring, Water and Bioburden applications. Because it continuously monitors CFU development, the Growth Direct® System can also be treated as a Rapid Microbiological Method. With proper validation, it can support a shorter TTR than the incubation times traditionally specified in the applicable compendial chapters.
The session will also outline the validation services Rapid Micro Biosystems offers to support customers through validation and regulatory submission.
In this webinar you’ll learn:
- How to develop a regulatory-defensible validation strategy without placing unnecessary strain on your laboratory resources.
- How to validate and implement a shorter Time to Results (TTR) for Environmental Monitoring, Water, and Bioburden applications.
- What European Pharmacopoeia 5.1.6, USP <1223>, PDA Technical Report No. 33, and relevant industry guidance mean in practice when validating an alternative or rapid microbiological method.
Validation Global Technical Lead
Rapid Micro Biosystems