Water Treatment Systems Seminar

Microbiological Control of Water Treatment Systems
Presented by Christine Craig, Ph.D.
Microbiology Consultant, ValSource, Inc.

Dr. Christine Craig is a microbiology consultant with ValSource, Inc. She has more than 15 years’ experience as a microbiologist with extensive expertise in pathogens and contamination control strategies. She has 6 years of specialized FDA regulatory experience performing risk-based product quality assessments of sterile and non-sterile drug products and has served as a microbiology subject matter expert (SME) within the Agency for contamination events, inspections, and 483 responses. As a microbiology consultant at ValSource, Inc., she applies her scientific and regulatory experiences to help ensure microbiological quality and safety in the pharmaceutical manufacturing industry. Dr. Craig’s goal and passion is to help industry meet or exceed FDA regulatory compliance requirements, while maintaining practical manufacturing processes. She holds a B.S in medical microbiology from University of California, Davis and a Ph.D. in molecular microbiology and immunology from Johns Hopkins University School of Public Health.

Water Treatment System Design
Presentation by Josh Capsavage
Senior Business Development Manager, Xylem

Josh Capsavage is a seasoned expert in water filtration, boasting a rich background encompassing quality control, process validation, and the engineering and design of water filtration systems tailored for both pharmaceutical and homeopathic sectors. With more than 18 years of extensive experience in sales and cGMP practices, he specializes in turn-key engineering, installation, and qualification of pure water systems. Recently appointed as the Senior Business Development Manager at Xylem Water, Josh directs his attention towards capital equipment and installation projects. Proudly based in Southern California, he resides with his wife Rachel and their three daughters, Ava, Emma, and Olivia.

Recent CGMP Deficiency Trends in Pharmaceutical Water Purification Systems
Presented by William Yang, Ph.D.
Consumer Safety Officer, FDA

William Yang, Ph.D. is a consumer safety officer in the Office of Manufacturing Quality, Office of Compliance within the Center for Drug Evaluation and Research at FDA. He has been with FDA since 2016. Prior to FDA, he was a senior process development engineer at a biotechnology company.

Special Q&A with Two FDA Officials

A second FDA representative will join Dr. Yang for a special Q&A after his presentation. Tamara L. Ely, Branch Chief in the FDA’s Office of Manufacturing Quality, Office of Compliance within CDER has previously addressed the homeopathic industry at the AAHP GMP Compliance Seminar, October 2023.