Upcoming Conferences & Webinars
Pharmaceutical Lifecycle: Leveraging Data Analytics, 3-day Virtual Course, taught by SynoloStats experts and hosted by BII WORLD Training, March 22-25, 2021
Speed to Market with Computational Advances in Designed Experiments, Oligonucleotide and Precision Therapeutics Virtual Congress, March 30-31, 2021
KENX Validation University, Dublin, June 28-30, 2021
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
Process Validation Lifecycle for Packaging Oral Solid Dosage Forms – M. Altekar, K. Giacoletti, et al., ISPE Discussion Paper (2020)
Process Validation in Context of Small Molecule DS an d DP Continuous Manufacturing – C. Evans, K. Giacoletti, et al., ISPE Discussion Paper (2019)
Leveraging Prior Knowledge and Data to Accelerate Development and Reduce Risk, Cover Article in the March, 2019 issue of the AAPS News Magazine
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
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