Since the introduction of Quality by Design, the concept of the analytical method has developed rapidly. This is reflected in the implementation of new and revised guidelines such as ICH Q2, ICH M10 and ICH Q14 for the validation of analytical and bioanalytical methods and for analytical Quality by Design. The revision of some chapters of the USP also reflects this trend.
In this webinar three Software-as-a-Service (SaaS) solutions - Enoval, Seelva and Transval - will be presented, which meet current and newly developed regulations for two key steps in the lifecycle of analytical methods and bioassays: Validation and Transfers. All three solutions enable them to obtain fully compliant reports in minutes and implement the proposals of the USP 1210 chapter by using statistical tolerance intervals and total errors to determine whether the analytical methods are suitable for the purpose. At the end of the study, you will have more confidence in the analytical results obtained with them.
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.
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.
Key learnings include:
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