News | April 28, 2014

US Food & Drug Administration Speaks Out On Pharmaceutical Water System And cGMP At June Conference For Pharmaceutical Industry Executives

ULTRAPURE WATER Pharma 2014 will be held at the Valley Forge DoubleTree Hotel, King of Prussia on June 3rd and 4th

The conference, hosted by ULTRAPURE WATER Journal is for executives from Biotech, Health Care and the Pharmaceutical industres and will focus on key issues for pharmaceutical water treatment-Compendial Water Systems and Microbial Control. It will cover state-of-the-art technical papers and tabletop exhibits.

Registration is open for the 2014 ULTRAPURE WATER Pharma (UPW Pharma) conference that will be conducted Tuesday, June 3rd, and Wednesday, June 4th, in greater Philadelphia at the Valley Forge DoubleTree Hotel in King of Prussia.

The meeting will begin with an address by Mr. Joe Manfredi, president of GMP Systems, on “Present Trends, Future Directions in Pharmaceutical Water Treatment.” Mr. Manfredi has spent more than 30 years in the design, building, and troubleshooting of pharmaceutical water treatment systems. He also has provided consulting for major pharmaceutical manufacturers, and currently teaches in pharmaceutical engineering Masters of Science program at the New Jersey Institute of Technology.

Next, Ms. Anita Michael of the FDA’s Wilmington, Del., offices will speak about the U.S. Food and Drug Administration’s (FDA) view on pharmaceutical water system validation and cGMP requirements.

These presentations are a part of Session 1 on “Compendial Water System Inspection”.

Attendees will also be able to learn more about the Parenteral Drug Association (PDA) and International Society of Pharmaceutical Engineer’s (ISPE) perspective on pharmaceutical water treatment issues. Mr. Igor Gorsky, a senior consultant with Concordia ValSource and head of the PDA’s Water Expert Group will review this topic from the PDA’s perspective.

On Tuesday afternoon, Mr. Nissan Cohen of Rohrback Cosaco will speak on updates to the International Society of Pharmaceutical Engineer’s (ISPE) critical utilities guide. Other technical talks on Day 1 will examine total organic carbon (TOC), conductivity in pharmaceutical water, and wastewater issues at pharma facilities.

Session 2 on June 4th will feature presentations on “Microbial Control in Purified Water Systems”. Mr. Edward Helmig of the Water Division of Arcadis will speak that morning on establishing and maintaining microbial purity in pharmaceutical water systems. Other paper topics addressing microbial control will include recirculating lab faucets, Good Manufacturing Practices, monitoring disinfectant residuals, and microbial control through improved standard operating practices. Day 2 will also highlight applications of electropositive diatomaceous in pharma water treatment, use of electrodeionization in pharma water treatment, and derouging of stainless steel piping and vessels.

UPW Pharma will be co-moderated by Mr. Gorsky and Mr. Manfredi.

In addition to the opportunity to learn from industry experts in the Executive Forum, UPW Pharma will also feature tabletop exhibits and offer attendees the opportunity to network with others active in different aspects of pharmaceutical water treatment.

For more information, visit

This conference is organized by ULTRAPURE WATER journal, a publication of Global Water Intelligence (

SOURCE: Ultrapure Water