Upcoming Conferences
  • Evidence of Quality: How Much is Enough?, IFPAC 2019, Bethesda, MD, March 3-6, 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
  • KENX Validation University, Philadelphia, PA March 25-27, 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
Recent Publications:
  • 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
  • Interview with Tara Scherder in “Reinventing Lean Six Sigma for the Pharmaceutical Industry,” in the October 2, 2017 issue of Pharmaceutical Technology (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,” in the July, 21 2017 issue of Pharmaceutical Online
  • 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
  • (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