Practical Designs for Validation of Bioassay Precision Consistent with ICH Q2(R2)

In our course, Quality by Design for the Lifecycle on an Analytical Procedure, we provide practical design considerations for the validation of assays that are consistent with the requirements in ICH Q2 (R2) Guideline on Validation of Analytical Procedures. Invariably, a participant will comment that the design considerations for bioassays are more nuanced than most other assays. We agree. Please join analytical development consultant Ken Lewis (Bioprocess Technology Group, BDO) and statistician Rick Burdick (Adsurgo) for a free seminar on Practical Designs for Validation of Bioassay Precision Consistent with ICH Q2(R2). An accompanying white paper will be provided to those in attendance following the seminar.