- This event has passed.
Water Treatment Systems Seminar
AAHP Water Treatment Systems Seminar
The American Association of Homeopathic Pharmacists is excited to present a virtual seminar on Water Treatment Systems for our industry. This event is open to both AAHP members and non-members.
3 Crucial Topics Discussed in Depth
A half-day cGMP seminar focused on one of the most common reasons for an FDA warning letter regarding homeopathic products: microbial contamination in non-sterile drug products. The webinar will facilitate a better understanding of water treatment system design and compliance requirements. It will help you improve product quality and be well prepared for FDA inspections.
William Yang, Ph.D., Consumer Safety Officer, FDA CDER
Discussion on trends in CGMP deviations and violations pertaining to pharmaceutical water purification systems noted in recent FDA drug warning letters.
Christine Craig, Ph.D., Microbiology Consultant, ValSource, Inc.
Discussion on microbiological control of water treatment systems.
Josh Capsavage, Senior Business Development Manager, Xylem
Practical overview and engineering perspective on designing water treatment systems.
Understanding water treatment systems design and what FDA takes into consideration is essential for all ongoing cGMP compliance efforts for all products produced using water. Mastering these focus areas will also better prepare your company for inspections and minimize potential impact on your day-to-day business activities. Ultimately this crucial education leads to manufacturing excellence and the production of safe, high quality, and pharmaceutical-grade homeopathic products. It also helps your company meet its compliance with statutory requirements for ongoing employee education.
Event Information
Virtual Only
Wednesday, June 12, 2024
from 12:00 p.m. (9 a.m. PDT) – 4:00 p.m. EDT (1 p.m. PDT)
Open to non-members; AAHP members receive a discount.
What You Will Learn
- Overview and examples of inspection enforcement.
- GMP requirements for water treatment systems.
- Design of an effective water treatment system.
- Microbiological quality standards for pharmaceutical water systems.
- FDA hot topics.
Who Should Attend
This seminar is a must-attend for all domestic and foreign firms who manufacture, label, pack, or hold homeopathic drug products for sale in the United States. Individuals who will find it worthwhile include:
- Quality Staff
- Legal & Regulatory Staff
- Product Leads
- Product R&D Staff
- Company Leaders (President/CEO)
- And those similarly responsible at your contract manufacturer
Please contact AAHP Secretary Eric L. Foxman via email at Info@AAHP.Info or by voice message at 513-402-8847 with questions.
Agenda
All times below are in Eastern Daylight Time.
-
12:00-12:10pm
Mark Land, M.S., RAC, AAHP - Welcome
-
12:10-1:10pm
Christine Craig, Ph.D., Valsource, Inc. - Microbiological Control of Water Treatment Systems
-
1:10-1:25pm
Break
-
1:25-2:25pm
Josh Capsavage, Xylem Water Technologies - Water Treatment System Design
-
2:25-2:40pm
Break
-
2:40-3:40pm
William Yang, Ph.D., FDA - Recent CGMP Deficiency Trends in Pharmaceutical Water Purification Systems
-
3:40-3:50pm
Mark Land, M.S., RAC, AAHP - Closing
About the Speakers
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.
Register
Early bird pricing is available through May 20, 2024 at 11:59pm EDT.