Virtual Classroom Training

Bespoke interactive e-learning

This training will provide deep insights into the objective of Validation and the Objective of Transfer, Regulatory expectations and guidelines in Transfer and many more topics. Register and learn from the knowledge of our expert Eric Rozet.

Type: Virtual Classroom Training

Duration: 2 Days (each divided into two 0.5-day sessions)

Who should attend?: Validation QC Manager

Transfer of analytical method and bioassay with applications. The training will cover the following topics:

  • Objective of Validation and Objective of Transfer
  • Regulatory expectations and guidelines in Transfer 
  • Analytical method transfer steps
  • Evaluation of the method transfer
  • The statistics to perform: Descriptive, equivalence, Total error, Assay performance vs Results, Mean results vs Individual results, Pros and cons
  • Defining Acceptance limits: performances vs results, Experimental design required for a successful transfer
  • Examples 

Eric Rozet 

Eric Rozet is Director Statistics at PharmaLex Belgium company in Louvain-la-Neuve (Belgium). He has 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 in Bayesian modeling and Designs of Experiments. He is also the 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’s degree in Biostatistics, and a Ph.D. degree in Pharmaceutical Sciences. 

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