Upcoming Conferences & Webinars
Recent Publications:
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
  • Right-Sized Sampling & Statistics for the PV Lifecycle, CSV, Data Integrity & Process Validation Virtual Summit, 2021 January 20-21, 2021
  • KENX Validation University, Puerto Rico-based (Virtual), Nov 9-10, 2020
  • 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
  • Modern Statistical Methods for the Data Challenges of Cell & Gene therapy, Oligonucleotide and Precision Therapeutics Congress, Oct 20, 2020
  • Process Validation Considerations for Large Molecule Continuous Manufacturing, ISPE Continuous Manufacturing Virtual Workshop, June 3-4, 2020
  • Statistical Solutions for the Data Challenges of Cell and Gene Therapy, PDA Annual Meeting, March 30 – April 1, 2020
  • KENX Validation University, Philadelphia, PA 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
  • KENX Validation University, Philadelphia, PA March 25-27, 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
  • Bayesian Statistics for Better Process Understanding & Prediction (Short Course), ASA/ASQ Fall Technical Conference, West Palm Beach, FL Oct 3-5, 2018
  • (1) Statistics for the QC Scientist, (2) Fit for Purpose Statistics for Stability: Shelf Life Modeling & Trending, & (3) Adopt a Systematic Approach for Method Robustness with Effective Design of Experiments (DoE)KENX Stability Testing and Program Management, Analytical Procedures & Methods Validation, San Diego, CA June 25 – 27, 2018
  • The Statistics Pendulum – What’s Best for the Patient?, ISPE Quality Manufacturing Conference, Arlington, VA, June 4-6, 2018
  • Patient and Business Benefit Leveraging Fundamental and Advanced Understanding of Statistics, Pharma ED Process Validation Summit, Philadelphia, PA, May 17-18, 2018
  • Comparability & Analytical Similarity (and CMC Track Chair), Midwest Biopharmaceutical Statistics Workshop (MBSW), Indianapolis IN, May 14 – 16, 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