|8-9 April 2013||Newton (Boston area), Massachusetts||USA||Gary V. Zoccolante|
|20-21 May 2013||St. Louis, Missouri||USA||Andrew Collentro|
|9-10 September 2013||Burlingame, California||USA||Andrew Collentro|
|9-10 December 2013||Tampa, Florida||USA||Gary V. Zoccolante|
You might also be interested in the Storage Delivery and Qualification of Pharmaceutical Waters training course.
Pharmaceutical water is perhaps the most important of all pharmaceutical utilities. It is used as an excipient in many pharmaceutical formulations, as a cleaning agent, and as a separately packaged product diluent. In addition to non-compendial systems, pharmaceutical facilities typically include systems for generating USP Purified Water (PW) and USP Water-For-Injection (WFI). This course has been substantially updated to feature the guiding principles of the newly released ISPE Baseline Guide: Water and Steam Systems (Second Edition) with particular emphasis placed upon the new chapters for microbial control and laboratory water as well as key design philosophies. The principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory applications, including the essential concepts and principles of systems used to generate USP and non-compendial waters will be covered. These concepts include specification, design, operation, testing, and maintenance of equipment and systems for water generation. Participants will examine methods for proper water quality selection, information on compendial and non-compendial waters, fundamentals of basic water chemistry, and information on common unit operations (deionization, reverse osmosis, and distillation). Pre-treatment systems, detailed guidance for selection of construction materials, and operations issues related to pharmaceutical water generation systems will also be discussed.
The course will also cover regulatory requirements including USP, EP, and JP Monographs, the FDA Guide to Inspections of High Purity Water Systems, current FDA views, and current Good Manufacturing Practice (cGMP) requirements. Common water system myths will also be explored and a variety of practical system designs will be evaluated for USP and FDA compliance, as well as their advantages and disadvantages. Particular attention will be paid to system and component sanitization procedures and microbial control.
Immediately apply the course learning objectives with the complimentary copies of the Water and Steam Systems Baseline® Guide (Second Edition) and the Good Practice Guide: C&Q of Water and Steam Systems.
This course includes a pre-recorded Webinar that provides a review of the basics prior to the classroom course. Access information will be provided via email one week prior to the start of the training event.
This training course is of particular interest to existing and future members of the ISPE Critical Utilities Community of Practice (COP).
This course contains knowledge related to the CPIP™ technical knowledge competency element Production Systems: Production Unit Operations - Drug (small molecule) and Biologics. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ISPE-PCC.org.
ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.
Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.