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This is a dual-track program featuring original case studies that relate directly to the concepts covered in the newly revised ISPE Baseline® Guide: Water and Steam Systems (Second Edition)

  • Introductory track: 18.30 – 20.30
    Designed for young professionals and anyone who wants to learn about pharmaceutical water at a more basic level.
  • Advanced track: 15.20 – 20.30

    Designed for professionals with a background knowledge of water; presentations will include case studies and in-depth information.

Who should attend

Anyone interested in learning current practices on water and steam systems, anyone preparing to defend an audit.

What you will learn

Attendees will learn from the Guide authors about case studies and behind the scenes input to the baseline guide. (A review of the baseline guide is not essential, but will provide important framework for this session.)

Confirmed Speakers

  • Cameron Sipe , PE, Principal Project Engineer, Pfizer – Primary author and editor, ISPE Baseline Guide: Water and Steam Systems (Second Edition)
    His specialty is “real world” design practices aimed at greatly reducing the risk of water quality failures while reducing maintenance.
    Presentation Abstracts
  • Dr. T.C. Soli, President, Soli Pharma Solutions, Inc. – Contributing author, ISPE Baseline Guide: Water and Steam Systems (Second Edition)
    He is in his third 5 year term on USP Expert Committees responsible for Pharmaceutical Water, is the author of USP’s Informational Chapter <1231> on pharmaceutical water, and helped develop the Water Conductivity and TOC specifications used by USP and adopted world-wide.
    Presentation Abstract
  • Gary Zoccolante, Pharmaceutical Technical Director for Siemens Industry Inc., Water Technologies Business Unit – Contributing author, ISPE Baseline Guide: Water and Steam Systems (Second Edition)
    Zoccolante developed the four-day ISPE Pharmaceutical Water course and presented the course to hundreds of pharmaceutical industry personnel including FDA personnel.
    Presentation Abstract
  • Andrew Collentro, Technical Director, Water Consulting Specialists, Inc. – Contributing author, ISPE Baseline Guide: Water and Steam Systems (Second Edition)
    He has more than 15 years of experience in the design, commissioning, and qualification of pharmaceutical water purification systems; specializing in process design and regulatory compliance of USP Purified Water and WFI Systems.
    Presentation Abstract
  • Joe Manfredi, President, GMP Systems Inc. – Contributing author, ISPE Baseline Guide: Water and Steam Systems (Second Edition); Chair, ISPE Critical Utilities Community of Practice (COP); Member, ISPE Critical Utilities COP Steering Committee
    Internationally recognized for his expertise in pharmaceutical processing, Manfredi has spent more than 30 years designing systems, overseeing fabrication and installation, trouble shooting, training and providing consulting services for most of the world’s major pharmaceutical manufacturers.
    Presentation Abstract
  • Philip Sumner, MS, PE, Senior Manager, Pfizer – Editor-in-Chief, ISPE Good Practice Guide: Ozone; contributing author, ISPE Baseline Guide: Water and Steam Systems (Second Edition)
    In his position with Pfizer as senior manager, he is responsible for GMP utility systems project design, reviews, and system operational support on a global basis.
    Presentation Abstracts
  • Daryl Roll, Chief Technology Officer, AstroPak Corporation – Contributing author, ISPE Baseline Guide: Water and Steam Systems (Second Edition)
    In his work for AstroPak, a provider of precision cleaning and passivation services to industries that utilize stainless steel equipment with ultrapure surface requirements, he directs the corporate research effort in pharmaceutical, semi-conductor and high-purity systems and chemical process technology.
    Presentation Abstract

Guides Discount!

Attendees will have the chance to buy the new Water and Steam Systems Baseline® Guide, the newly released ISPE Good Practice Guide: Process Gases, and pre-order the upcoming ISPE Good Practice Guide: Ozone at special discount prices!

Downloads

Handouts and presentations will be posted online for download one week prior to the event. They will not be provided at the event. You will receive an email once the handouts are available.