
Critical Utilities: Pharmaceutical Water and Gas Systems (E06)
4-5 June
1.2 CEUs
Working Agenda
Current as of 1 Mayl 2008
Download Working Agenda
PDF, 37 KB
At this two day session focused on pharmaceutical water and gas systems, hear from recognized and respected experts in the pharmaceutical water, steam and gas utility community. They will address a wide range of topics from an engineering, quality, and regulatory perspective.
At no other conference in the United States this year will you encounter such a collection of subject matter experts.
In addition to these leading engineers, you will be among other users and practitioners in the audience to participate in the open forums. Finally, you will be in a position to contribute directly to the update of the Water and Steam Guide, and the creation of the Good Practice Guide for Gas Utilities.
Day 1 is dedicated to industry hot topics and case studies such as applications of ozone sanitization, pre-treatment systems, analytical detection methods for rouge impact, rapid microbiological methods (RMMs), and alternative methods of water for injection (WFI) production.
Day 2 is an overview of the ISPE Water and Steam Baseline® Guide update which is planned for 2009. In addition to providing an overview of changes to existing chapters, there will be an emphasis on new chapters and international perspectives. Also, Day 2 will review the status of the planned Good Practice Guide for Gas Utilities. Each day will also have an open forum for exchange of ideas, experiences, and extensive questions.
Program Committee
- Anthony Bevilacqua, Director, Research/Development, Mettler-Toledo Thornton Inc., USA
- Chad Larrabee, Category Manager, Configured Air Solutions, Ingersoll-Rand, USA
- Carl Roe, Technical Leader, Water Systems, Abbott Laboratories, USA
- Brian Severson, Senior Principal Engineer, Baxter Healthcare Corp., USA
How You Will Benefit
At the conclusion of this session, participants will be able to:
- Understand real-world case studies of sanitization by ozone and non-traditional methods of WFI production;
- Describe emerging technologies in RMM and rouge detection;
- Interpret insights on FDA methods for inspection of water systems;
- Understand the challenges faced by other critical utility engineers; and
- Review, respond, and contribute to the update of the ISPE Water and Steam Baseline® Guide and the Good Practice Guide for Gas Utilities.
Who Should Attend
Utilities engineers, water system designers, facilities engineers, equipment and design engineers, process engineers, quality professionals, users of the Guide, and those interested in the new guidance that will address gas, supplies, gas delivery systems, and facilities management.
Benefits those new to the industry, critical utilities operators, designers, maintenance, as well as experienced persons who are interested in contributing to the Guide revision. Also, anyone with interest in validation, commissioning, critical utilities, project managers, facilities engineers, and systems operation.
Communities of Practice (COPs)
Critical Utilities (CU), Commissioning and Qualification (C&Q), and Project Management (PM)
Related Technical Documents Available from ISPE - www.ISPE.org/publications
ISPE Good Pratice Guide: Commissioning and Qualification of Pharmaceutical Water and Steam Systems, and the Water and Steam Systems Baseline® Guide
Seminar Leaders
- Anthony Bevilacqua, Director, Research/Development, Mettler-Toledo Thornton Inc
- Brian Severson, Senior Principal Engineer, Baxter Healthcare Corp
Speakers
- Katrin Akerlindh, Global Business Dev Mgr, Linde Gas
- Andrew Collentro, Technical Director, Water Consulting Specialists, Inc.
- Joseph De Paul, President, Skye Technical Services
- Michelle Gonzalez, Retired, Amgen Inc
- Michael Holland, Product Manager, GE Water & Process Technologies
- Thomas Larkin, Director of Engineering, Shire HGT
- Chad Larrabee, Category Mgr, Configured Air Solutions, Ingersoll-Rand
- Peter Petrillo, Principal, Millennium Facilities Resources Inc
- N. Cameron Sipe, Principal Project Engineer, Wyeth Biotech
- Scott Sutton, PhD, Sr. Director, Microbiology Services, Vectech Pharmaceutical Consultants, Inc.
- Frank Van Der Steen, Validation Manager, Synco Bio Partners B.V.
- James Vogel, PE, Principal, Process Facilities Services Incorporated
- Gary Zoccolante, Pharma Tech Director, Siemens Water Tech Corp
