This two day course will cover basic statistical processes necessary for analysis of the data from bioassays; setting up meaningful system suitability acceptance criteria and designing validation plans. Important considerations will be examined such as choosing the appropriate non-linear or linear regression fit, calculating correct residual weights, computing practical limits of sensitivity and acceptable error, and measuring non-parallelism and potency.
This course is also available for studying online, check website for dates>>
Dr. Zeban Kolen is the Lead Scientist and line manager of the Protein Potency team of the Bioanalytical Department of Synthon Biopharmaceuticals.
Dr. Melody Sauerborn spent most of her early scientific career at prestigious institutes such as the Centre for Disease and Control Prevention in the USA. She has been involved in a number of biotech start-ups and also works as a consultant as well as a speaker/ trainer at international conferences and workshops.
This course is designed for all individuals who
develop, validate, perform or monitor bioassays
or immunoassays. Individuals who develop
assay methodologies, assign computational and
analysis criteria, measure and validate performance
characteristics, perform, evaluate and troubleshoot
problem assays, or are responsible for the quality
of the data will benefi t from the lessons and
examples presented. Attendees should have a basic
understanding of bioassays or immunoassays.
The trainers performance was simple to understand and covered all the areas I needed training in.
The statistical part of the course was excellent.