Pharmaceutical Water and the International Regulatory Environment Training Course :

Water is the single largest ingredient used in biopharmaceutical manufacturing and permeates every aspect of biopharmaceutical manufacturing. The uses of water and steam derived from water, constitutes a major operational and quality issue in the industry on a world-wide basis. As such, water is governed by specific requirements for quality and use. This course will review U.S. and all pertinent international standards, as well as options for meeting each.<br><br> <b>Module 1:</b><li> Overview of U.S. and International regulatory environment</li> <li>Where water and utility systems fit within the regulatory framework</li> <li>Regulatory Standards for Water<br> &ndash; Potable Water Sources and the National Safe Drinking Water Act<br> &ndash; Non-compendial Waters (ASTM, CAP, AAMP, Other)</li></ul><br><br> <b>Module 2:</b><li> U.S. Pharmacopoeial Waters (USP Purified, Water For Injection, Other)</li> <li>Alert vs. Action Limits</li> <li>Current Changes in USP Requirements</li><br><br> <b>Module 3:</b><li> International Standards (EP, JP, Canadian and others)</li> <li>Harmonization Strategies between standards</li> <li>Evolving changes in water standards</li> <li>Question & Answer</li>