QbD – Analytical Quality by Design

Duration: 1 hour & 14 minutes


Registration

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Why watch

Key Learnings: 

  •  You will learn what is Quality by Design for Analytical Methods and Bioassays
  •  You will learn the different steps of the Life Cycle of Analytical Methods and Bioassays and how they interact
  •  You will understand what is fit for purpose development, optimization,  validation and transfer of analytical methods and bioassays
  •  You will understand the statistical methodologies suggested in the USP 1210 chapter for the validation and transfer of analytical methods and bioassays  
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.

 

Pierre Lebrun

Director Statistics, PharmaLex

Pierre Lebrun is Director Statistics at Pharmalex Belgium, dedicated to statistical expertise. During more than 14 years, Pierre specialized in quality-by-design aspects related to processes and assays, with a strong emphasis on the use of Bayesian statistics to improve knowledge during the process and assay validation stages. Pierre is also a recognized trainer in statistics for the pharmaceutical industry, including design of experiments, Bayesian statistics, statistical process control, and assay development and validation. Two years ago, Pierre joined the USP panel in charge of the development of the USP 1220 chapter about a holistic approach to assay validation using the concept of the analytical procedure lifecycle.