Critical Utilities (Session 105)

Sunday 6 November 13.00 – 17.00

ISPE CEUs: 0.35

The quality of water, steam and gases must be verified where the utility is delivered. This session will address risk-based sampling programs, GMP sampling techniques, sources of error, and corrective action. Case studies will be presented for on-line release and supplementary analytical techniques. Design challenges with use-point design and acquiring representative samples will be discussed. This includes the frequency of use point monitoring for critical utilities and elimination of use-point testing altogether. This session will serve as a springboard for the proposed ISPE Good Practice Guide on Sampling for Critical Utilities. Anyone interested in participating with the upcoming Guide is encouraged to attend.

Leaders

Speakers

• Jeff Campie, USA
• Richard Forsyth, Senior Consultant, Hyde Engineering + Consulting, USA
• Nigel Hamilton, Global Quality, Strategy and Process Excellence, Sanofi Aventis, United Kingdom
• Aisling Horan, Validation Scientist, Alkermes Plc, Ireland
• Edwin Melendez, Principle Consultant, Parexel, USA
• Mark O'Reilly, Director Engineering, Alkermes Pharma Ireland Ltd, Ireland
• Kimberly Ray, A. Director Project Mgmt, Oso Biopharmaceuticals Mfg LLC, USA
• Julian Wilkins, Vice President, PharmaConsult US Inc, USA
• Paul Wreglesworth, Independent Consultant, United Kingdom

How You Will Benefit

• Evaluate the misconceptions with cGMPs for pharmaceutical water systems
• Understand industry trends related to Critical Utilities
• Determine how to react to industry myths or regulatory findings for Critical Utilities

Who Should Attend

Design Engineers, Process Engineers, Project Managers, and Utility/Facility Engineers

Communities of Practice (COPs)

This session is of particular interest to existing and future members of the following ISPE Communities of Practice (COPs):

Critical Utilities, C&Q, and PAT