Skip to content
Upcoming Conferences & Webinars
Recent Publications:
-
Bayesian Statistics for Manufacturing T. Scherder & K. Giacoletti (2020), in E. Lesaffre, G. Baio, B. Boulanger (Eds.) Bayesian Methods in Pharmaceutical Research, 1st. Edition, Chapman & Hall/CRC Biostatisics Series
-
-
-
-
Continued Process Verification – T. Scherder & K. Giacoletti (2018), in Todd Coffey & Harry Yang (Eds.) Statistics for Biotechnology Process Development, 1st. Edition, Boca Raton, FL: CRC Press/Taylor & Francis Group
-
-
-
Insights for getting more value from CPV – T. Scherder “Embrace Special Cause Variation during CPV,” in the May/June 2017 issue of Pharmaceutical Engineering
-
Important considerations for PPQ Acceptance criteria – T. Scherder “Understand and Address the Risk of Statistical Intervals as Acceptance Criteria in Process Performance Qualification (PPQ),” in the Feb 2017 issue of the JVT Journal
Recent Presentations
-
Modern Statistical Methods Accelerate Development & Reduce Risk, Podium Talk at the PDA Annual Meeting, March 15-17, 2021
-
Statistics in Validation 1-day Webinar co-hosted by KENX and SynoloStats, February 11, 2021
-
-
-
Caution: Statistics Ahead! Common Mistakes to Avoid, ISPE Annual Meeting and Expo, Nov 2-5, 2020
-
Process Validation Lifecycle Stage 1 (Development) Challenges for Adeno-Associated Virus Gene Therapy Products for Rare Diseases, ISPE Annual Meeting and Expo, Nov 2-5, 2020
-
Methods for Specification Determination with Small Sample Sizes, AAPS PharmSci 360, Nov 2, 2020
-
Statistical Solutions for Cell and Gene Therapy Data Challenges, AAPS PharmSci 360, Nov 3, 2020
-
Statistics as a Risk Management Tool, KENX Validation University, Philadelphia-based, August 25, 2020
-
-
-
Statistical Solutions for the Data Challenges of Cell and Gene Therapy, PDA Annual Meeting, March 30 – April 1, 2020
-
-
(1) Right-Sized Sampling and Statistics for PPQ, (2) Optimize Validation Using Innovative Statistical Modeling Across the Process Lifecycle, AAPS PharmSci360 , San Antonio, TX, Nov 3-6, 2019
-
Leveraging DOE: Choosing the Optimal Design, ISPE Annual Meeting & Expo, Las Vegas, NV, Oct 27-30, 2019
-
Patient Focused Statistics in PV,IVT Validation Week Las Vegas, NV Oct 16-18, 2019
-
(1) Finding the Goldilocks Zone for Enhanced Sampling in PPQ & CPV, (2) Red is the New Black and Other CPV Paradigm Shifts, Pharma Ed Process Validation 2019 Summit, La Jolla, CA, June 12-13, 2019
-
-
Smarter Statistics for Accelerated Approvals: Using Prior Information to Accelerate Development and Assure Ongoing Quality, PDA Annual Meeting, San Diego, CA, March 11-13, 2019
-
Evidence of Quality: How Much is Enough?, IFPAC 2019, Bethesda, MD, March 3-6, 2019
-
5th IABS Statistics Workshop – Approaches for CMC Development and Lifecycle Management of Biotherapeutics and Vaccines (discussion moderator), Rockville, MD, Nov 26 – 28, 2018
-
(1) Risk Management Tools for Validation, (2) Process Validation Statistics for Business’ Sake – Statistics for Non-Statisticians, and (3) Leverage Design of Experiments (DOE) to Define and Effective Control Strategy, KENX Commissioning, Qualification, & Validation University, Dublin, Ireland, Nov 19-21 2018
-
-
-
-
-
-
The Need for both Fundamental and Advanced Understanding to Design Lean Statistical Approaches, Pharma Analytics Summit, Philadelphia, PA March 26-27 2018
-
KENX Commissioning, Qualification, & Validation University: Process Validation & Continued Process Verification, San Diego CA, Feb 26-28 2018
-
Process Understanding & Prediction using Innovative Statistics, Apply Lean Thinking During Continued Process Verification, Standardization of the Use of Statistics Across the Product Lifecycle, … and more at IFPAC, Bethesda MD, Feb 11-14 2018
-
Harmonization of the Role and Application of Statistical Methods For Process Validation, ISPE Annual Meeting & Expo, San Diego CA, Oct 29-Nov 1, 2017
-
Using Innovative Statistics for Increased Quality, Faster Development, ASA/ASQ Fall Technical Conference, Philadelphia PA, Oct 2017
-
Overcome Common Pitfalls in Lifecycle Process Validation Statistics, IPA 13th annual GMP Update, Montreal, Canada, September 28-29, 2017
-
Applying Lean Thinking to Optimize CPV, ISPE Process Validation Conference, September 12-14, 2017
-
Evolving Trends in the Use of Statistics for Process Validation, IVT 3rd Annual Statistics in Validation June 20-22, 2017
-
Understand the Benefit and Danger of Statistical Acceptance Criteria for PPQ, IVT 3rd Annual Statistics in Validation June 20-22, 2017
-
Chair & Moderator of Continued Process Verification session, Midwest Biopharmaceutical Statistics Workshop (MBSW), Muncie IN, May 2017
-
Using Innovative Statistics to Meet Challenges of Fast Track/Breakthrough Therapy Designations, AAPS National Biotechnology Conference, San Diego CA, May 1-3, 2017
-
Innovative Statistics for Accelerated Approval Pathways, IFPAC, Bethesda MD, Feb 27-Mar 2, 2017