Pharmaceutical Water Systems (T35)

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Training

Level: Intermediate
ISPE CEUs: 2.0
Type: Classroom Training Course
Includes Webinar

Date	Location	Country	Instructor(s)
This course is not currently scheduled, but may be offered at your company site. Please contact ISPE for more information.

Description

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.

Course Modules

Regulatory
Planning and Programming
Pretreatment and Purification Processes
Choice of Systems and Processes
Basic Chemistry and Microbiology
Sanitisation
Storage and Distribution Configurations
Storage and Distribution Design
Commissioning and Validation

Water and Steam Systems Cover C and Q of Water and Steam Cover

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.

Includes Webinar

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.

Webinar Learning Objectives

Discuss regulatory requirements, current FDA views and current Good Manufacturing Practices (cGMP) as they relate to pharmaceutical water systems
Explain the effect of the cGMPs, FDA guidance documents, ISPE Baseline® Guides, and other reference documents on water system design, construction, maintenance and validation
Compare common water process design alternatives for USP PW and WFI system

Take Back to Your Job

Differentiate regulatory requirements from myths relative to water generation, distribution and storage systems
Identify alternative system designs and their advantages and disadvantages
Understand the importance of microbiological control and analyse the principles behind water system testing and qualification
Understand the impact of water quality requirements (compendial and non-compendial) on water system operations
Define the basic requirements for water distribution system component installation and overall system construction
Integrate and streamline commissioning and validation activities

Attendance Suggested For

Pharmaceutical professionals who are new to water treatment systems or those with significant engineering expertise from another industry who need to learn about pharmaceutical water treatment systems
Those with significant industry experience in other capacities that now have water generation system engineering and/or maintenance responsibilities and want to gain a fundamental understanding of the requirements for designing, building, operating, testing, and maintaining these systems
Water treatment systems quality assurance and quality control specialists, manufacturing supervisors, technical support personnel, and all levels of management who want to gain a fundamental understanding of pharmaceutical water generation systems
Professionals who are new to pharmaceutical water distribution systems
Those with significant engineering expertise from another industry who need to learn about pharmaceutical water distribution systems
Quality assurance and quality control specialists, manufacturing supervisors, technical support personnel, validation personnel, and all levels of management who want to gain a fundamental understanding of pharmaceutical water systems

Continuing Education Units

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.

Last Update: 15 April 2013