Rapid Microbiological Method Statistics & Validation

It is well known that implementation of Rapid Microbiological Methods in Pharma environments is accompanied by a large validation workload to ensure that the methods provide reliable results and will be compliant to regulations. BUT what is the minimum you have to provide to convince yourself, your stakeholders and the authorities? How can you facilitate the validation process? Which statistical methods are best suited to the analysis of the results? In a question and answer format Edwin van den Heuvel and Marcel Goverde will provide their view on commonly asked questions including recommendations for the validation approach and customer examples. The first part of the semi-live seminar will address general validation questions while the second part will focus on statistics.  Finally, participants can address their questions to the speakers in the Q&A session.