Alternative And Rapid Microbiological Methods: Microbiology Of The 21st Century


08th April 2019 | 10:00 am CEST | Presented by Dr Benoit Ramond, Head of Microbiology & Sterile Technology, Sanofi |BOOK FREE SEAT

Today Pharmaceutical industry remains conservative for microbiology testing methods and has the reluctance to develop and to use Alternative and Rapid Microbiological Methods (RMM) supported by a number of misunderstandings and prejudgments based on the following myths:

– RMM are not accepted by regulation authorities,
– RMM will never replace classical microbial methods,
– RMM will not offer a return on investment (ROI),
– Data generated from RMMs will exceed current specifications and limits involving an increase in batch rejections.

Nevertheless, a movement is in progress for the use of new technologies and systems because classical microbial methods, in spite of their long return of experiences and their confidence for the regulatory point of view, have a number of disadvantages such as:

– Time to results in days to weeks,
– Results vary with microbial population, media, culture conditions,
– Lack of reactivity in case of exceeding limit results,
– Sensitivity could be insufficient giving underestimations in the contamination risk,
– The existence of confluent growth.

This webinar provides an overview of the current situation about RMM technologies, regulatory expectations, it proposes some initiatives facilitating the implementation of RMM including a strategy for validation and it gives a projection for the perspectives of the RMMs for the future.

Presented by Dr Benoit Ramond, Head of Microbiology & Sterile Technology, Sanofi

Benoît Ramond is Doctor in Pharmacy at the University of Paris XI in France and obtains a PhD in Microbiology. He has 29 years of experiences in the Pharmaceutical Industry. Since 2017 he is Head of Microbiology and Sterile Technology in Sanofi group. In his function, he has also a leading role in the RMM strategy development within Sanofi group.

 

 

 

 


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