|This course is not currently scheduled, but may be offered at your company site. Please contact ISPE for more information.|
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 delivering pharmacopoeial Purified Water (PW) Water for Injections (WFI), and Highly Purified Water (HPW).
This course has been substantially updated to feature the guiding principles of the ISPE Baseline Guide: Water and Steam Systems (Second Edition) with particular emphasis placed upon 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, EP 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 and receive detailed guidance regarding the choice and use of appropriate construction materials and instrumentation. Particular attention will be paid to system and component sanitisation procedures and microbial control while participants will receive guidance regarding appropriate monitoring programmes during ongoing operation as well as during initial system qualification.
The course will also cover regulatory requirements including USP, EP, and JP Monographs, the USFDA 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 EP, EMA, 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.
Additional content from the ISPE Good Practice Guide: C&Q of Water and Steam Systems (Second Edition) will include the risk assessment and risk mitigation process used during design and qualification is crucial to ensuring product quality, allowing system designers and operators to gain process understanding of those product/process quality attributes which affect water or steam quality. The course will use a risk assessment example to determine the critical aspects, definition of critical quality attributes/critical process parameters (CQA/CPP), and identification/appropriate execution of quality indicating verification activities applied throughout the Validation Life Cycle.
Examples of a science and risk-based risk-management process for water and steam systems and typical system boundaries and critical aspects examples are discussed. Information is provided on the URs, FS, and how a QbD approach including Critical Aspects (CA) – CQAs and CPPs may be implemented. The module provides an alternative “science and risk-based” method that can be applied to the qualification of GMP water and steam systems.
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 (Second Edition).
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.
ISPE will provide continuing education units (ISPE CEUs) for all North American and European courses. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be available for download in your ISPE account within four weeks of the completion of training. Instruction for download will be sent when the CEUs are available. One hour of education programming equals 0.1 ISPE CEU credits.
Clinical Labeling of Medicinal Products: EU Clinical Trial Regulation
Tuesday, 03 May 2016 18.05
Design Considerations for WFI Distillation Systems Part 2
Thursday, 28 Apr 2016 18.04
2016 Annual Meeting Honorary Chair, Joseph Jimenez, Novartis
Tuesday, 26 Apr 2016 12.04