Analytical method development and validation in the pharmaceutical industry is currently evolving with more emphasis now being placed on understanding the measurement error. This change presents challenges and will require analytical scientists to understand calculation of new metrics. This webinar will cover advances in developing analytical methods.
During this webinar you will learn about:
- ‘The Analytical Procedure Lifecycle’ – a new draft general chapter from the United States Pharmacopeia (USP) validation and verification expert panel
- Calculations to support the development and qualification of analytical methods
- Easy-to-use tools that can process results and visualise outcomes
Speakers
Speaker: Christel Kronig
Senior analytical scientist, Dr Reddy’s Laboratories EU Ltd
During her 25+ years experience in the pharmaceutical industry, Christel has led teams of analytical scientists to support API development, including method development, validation and transfer. Through her work, Christel has developed a keen interest in applying statistics to support science-based decision making during process and analytical development.
Speaker: Phil Kay
JMP Senior Systems Engineer, SAS
Previously, Phil was a key scientist in the development of numerous processes for the manufacture of colorants for digital printing at FujiFilm Imaging Colorants. Phil has a master’s degree and a PhD in chemistry, a master’s in applied statistics, and is a Chartered Chemist.
Moderator: Benjamin Valsler
Digital Editor, Chemistry World
Ben Valsler is the digital editor of Chemistry World magazine, producing video and podcasts to accompany the magazine and website. Prior to joining the Royal Society of Chemistry, he was the producer of the award-winning Naked Scientists, making local and national radio programmes for the BBC, the Australian Broadcasting Corporation and Primedia in South Africa.