⦁ Insights for getting more value from CPV – T. Scherder, J. Crichton, A. Dander, and M. Shivhare, “Benefits and Challenges of Process Capability Metrics,” Pharmaceutical Engineering November/December 2023

⦁ Bayesian Methods in CMC – K. Giacoletti & T. Scherder, Bayesian Prediction for Staged Testing Procedures, and P. Sondag, JY Kim, L. Natalis, & T. Scherder, Bayesian Alternatives to Traditional Methods for Estimating Product Shelf Life and Internal Release Limits, in P. Faya, T. Pourmohamad (Eds.), Case Studies in Bayesian Methods for Biopharmaceutical CMC, 1st. Edition, Chapman & Hall/CRC Biostatistics Series, 2023

⦁ Bayesian Methods in CMC – T. Scherder & K. Giacoletti, Bayesian Statistics for Manufacturing,  in E. Lesaffre, G. Baio, B. Boulanger (Eds.), ⦁ Bayesian Methods in Pharmaceutical Research, 1st. Edition, Chapman & Hall/CRC Biostatistics Series, 2020

⦁ Bayesian Methods in CMC – T. Scherder & K. Giacoletti, “Leveraging Prior Knowledge and Data to Accelerate Development and Reduce Risk”, AAPS News Magazine, March, 2019

⦁ Continued Process Verification – T. Scherder & K. Giacoletti in Todd Coffey & Harry Yang (Eds.) . Statistics for Biotechnology Process Development, 1st. Edition, Boca Raton, FL: CRC Press/Taylor & Francis Group, 2018

⦁ Lean Six Sigma – Interview with Tara Scherder in “Reinventing Lean Six Sigma for the Pharmaceutical Industry”, Pharmaceutical Technology, October 2, 2017 (Vol. 41, Issue 10)

⦁ Risk-based thinking for aseptic processes – T. Scherder, J. Agalloco, D. Hussong, L. Mestrandrea, ⦁ “An Evaluation of a Closed Sterile Transfer Process for Aseptic Filling”, Pharmaceutical Online, July 21, 2017

⦁ Insights for getting more value from CPV – T. Scherder “Embrace Special Cause Variation during CPV”, Pharmaceutical Engineering, May/June 2017

⦁ Important considerations for PPQ Acceptance criteria – T. Scherder, “Understand and Address the Risk of Statistical Intervals as Acceptance Criteria in Process Performance Qualification (PPQ),”  JVT Journal, Feb 2017

⦁ Analytical Procedure Validation – E. Rozet, P. Lebrun, JF Michiels, P. Sondag, T. Scherder, B. Boulanger, ”Analytical Procedure Validation and the Quality by Design Paradigm, Journal of Biopharmaceutical Statistics, 2015(25)