The pharma and biotech industries spend millions of dollars annually in costly investigations into alert, action, and out of specification excursions related to the critical utilities of water and steam. These expenditures could be greatly minimized if the issues and challenges related to sampling were clearly understood. To address this knowledge gap, ISPE has introduced a new industry benchmark covering all aspects of sampling, the “Good Practice Guide – Sampling of Pharmaceutical Water, Steam, and Process Gases.” Join us at Biogen on Thursday, February 16 for an exciting half-day program devoted to the latest developments in pharmaceutical water and steam and get valuable input from the authors of this first-of-its-kind guidance document.
While not legally enforceable, regulatory authorities are relying more and more on “USP <1231> Water for Pharmaceutical Purposes” as they visit sites and inspect systems for compliance purposes. The program will include a review of USP <1231> with special emphasis on recent changes and their impact on pharmaceutical operations. Also included will be an overview of the industry’s next big breakthrough: the rapid detection of microbiological activity in pharmaceutical water systems and its application for process and quality control purposes.
The Boston Area Chapter and the ISPE Critical Utility Community of Practice are joining forces to offer this combined afternoon and evening educational program to provide Members with valuable updates on the critical utilities of water and steam. You are invited to attend either or both of the sessions for one low price which includes a casual networking reception with appetizers and refreshments. We look forward to seeing you there!