Publications and Presentations

“Rapid Microbial Monitoring: Adoption, Applications, and Regulatory Guidance”, Pharmaceutical Engineering, September/October 2018, Volume 38 Number 5

International Society for Pharmaceutical Engineering, "Baseline Guide for Water and Steam Systems" 2019 co-chair, author, anad chapter leader

International Society for Pharmaceutical Engineering,, Good Practice Guide for "Approaches for Commissioning and Qualification of Water and Steam Systems" 2017 ,co-chair, author, and editing author.

“Breaking the Paradigm:  New Technologies, Ideas, and Adaptations for Biotechnology Facilities”, Pharmaceutical Engineering, September/October 2016, Volume 36 Number 5

“Performance and Validation of Ozone Generation for Pharmaceutical Water Systems”, Pharmaceutical Engineering, July/August 2017 Volume 37 Number 4

“Myths and Realities: The Legacy of Obsolete SOPs and Specifications in Modern Pharmaceutical Water Systems”, Ultrapure Water Pharmaceutical Conference, June 2015

Rapid Microbial Monitoring: Regulatory and Application Strategies for Pharmaceutical Water Systems, “ISPE Los Angeles Chapter Symposium”, May 2015

“Chemical and Media-Free Pretreatment for Biopharma RO – Electrolysis for Scale Precipitation UV Dechlorination”, Pharmaceutical Engineering, July/August 2014 Volume 34 Number 4

“The Efficacy of Ozonated Water in Biofilm Control in USP Purified Water and Storage” Pharmaceutical Engineering, November/December 2013

“The Efficacy of Ozone and Chemical Sanitization for Microbial Control” Ultrapure Water Pharmaceutical Conference, June 2013

“Understanding Dissolved Ozone and Its Use in Pharmaceutical Water Systems”, Pharmaceutical Engineering, KB-0027 May 2013

“Online Rouge Monitoring: A Science-Based Technology to Measure Rouge Rates”, Pharmaceutical Engineering, November/December 2011

International Society for Pharmaceutical Engineering, Good Practice Guide for "Ozone" 2017 , contributing author.

Economic and Efficacy Comparison between Ozone and Hot Water Sanitization”, ISPE Water Conference, June 2010

“How Smart is Your TOC Analyzer?” Pharmaceutical Engineering, January/February 2008

“Validation of a Water System for the 21st Century”, Presentation, International Society for Pharmaceutical Engineering (ISPE), October 2007

“The Use of Exponentially Weighted Process Statistics (EWPS) and Statistical Process Control (SPC) in High Frequency Data Acquisition of Pharmaceutical Waters Systems Instrumentation”, Pharmaceutical Engineering, March/April 2007

“Validation of a new piece of process equipment – PAT vs. traditional validation”, Presentation ISPE Winter Meeting, February 2007, Tampa FL

“The Computerization of Water Systems including On-line Instrumentation, Integration, Electronically Generated Documentation, SPC, and High Frequency Data.” Presentation ISPE Winter Meeting, February 2006, Tampa, FL

Automated Release of Water Using On-line TOC Analysis and FDA Risk-based cGMP, Inspection and PAT Principles”, Pharmaceutical Engineering, January/February 2005

“Calculating the Cost of a Purified and WFI Water System”, ISPEAK, International Society for Pharmaceutical Engineering, August 2004

“Power: The Unregulated Utility in the Pharmaceutical Environment”, A2C2 Magazine, May 2004

“An Introduction to Process Analytical Technology”, Pharmaceutical Engineering, January/February 2004

“Monitoring Mission-Critical 24/7 IT Data Centers in a Pharmaceutical Facility”, Pharmaceutical Engineering, January/February 2002

“Validation of a Water System for the 21st Century”, Pharmaceutical Engineering, July/August 1999

“System Suitability is Not Calibration”, presented Ultrapure Water Conference, May 1998

“Pretreatment Strategies for TOC Reduction in WFI and USP Purified Water”, Pharmaceutical Technology, June 1995