Making Decisions with Probability Distributions
Making Decisions with Probability Distributions An overview of 13 continuous and 5 discrete probability distributions useful for risk assessment and other applications. Includes a description of the probability density, cumulative distribution, and quantile functions of each as well as MS Excel formulae for their evaluation. Methods for generating random samples from these distributions and some additional MS Excel matrix algebra capabilities are described.
CASS Midwest Discussion Group, June 2016
Biopharmaceutical Method Transfer as Part of the Quality System How can a risk based approach to method transfer and integration of the method transfer process into the larger quality system allow for greater assurance that the transfer does not impact drug safety not only at the time of transfer, but also in the lifecycle management of the drug?
Statistical Process and Control - Background and Application
Overview of Statistical Process and Control An overview of statistical process and control that can be used for SPC training and Biopharmaceutical SPC training. The presentation covers areas including Process Monitoring, Method Monitoring, Continuous Process Verification, and Quality Metrics.