Software Suite for the Life Cycle of Analytical Methods & Bioassays: Gain Trust in your Results

Duration: 1 hour & 2 minutes


Registration

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Why watch

Key Learnings: 

  •  Learn about Life Cycle of Analytical Methods and new regulatory expectations
  •  Learn how a validation or transfer study can be analyzed in a fit-for-purpose manner
  •  Learn how Enoval, Seelva and Transval can help fulfill the current and new regulatory expectations
  •  Understand how USP 1210 chapter and the statistical tolerance intervals can be used to assess the quality of the results of analytical methods and assays
  •  Learn to focus on analytical results’ quality and not only on analytical methods’ quality
speakers

A full day of inspirational speakers

Proud to bring inspirational speakers from across the globe. 


 

 

 

 

 

 

 

 

Eric Rozet

Director Statistics, PharmaLex

Eric Rozet is Director Statistics at PharmaLex Belgium company in Louvain-la-Neuve (Belgium). He has an experience of more than 15 years in pre-clinical, non-clinical statistics and CMC in particular in statistical aspects related to (bio)assays and (bio)processes development, optimization, validation, transfers. He trains statisticians and analysts of the Bio-Pharmaceutical Industry on topics such as optimization, validation, robustness and transfer of analytical methods and processes. Eric also trains Statistician into Bayesian modeling and Designs of Experiments. He is also author of more than 100 articles and book chapters in applied statistics and is regularly giving conferences on these subjects. Eric has a B.Sc. degree in Bio-engineering, a Master degree in Biostatistics and a PhD degree in Pharmaceutical Sciences.

 

Nicolas Pointereau

Analytics and Validation, Qualilab

Nicolas Pointereau is Responsible for analytics and validation operations at Qualilab in Olivet (France). He has an experience of 15 years in Audit, support and training missions in the Biotechnology, Chemical (Active Ingredients), Cosmetics (R&D, Manufacturing) and Pharmaceutical (R&D, Manufacturing, Dry forms and injectable liquids) industry.
Nicolas has a master degree in analytical chemistry & quality.