Pharmaceutical Water Systems: Regulation, Purification, Distribution and Validation

ISPE CEUs*: 2.0 Type: Classroom Training Course Level: Advanced

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) and Water for Injections (WFI).

This course covers the principles of design and operation of water systems used directly in pharmaceutical manufacturing, including the fundamental concepts and principles for systems used to generate, store and distribute both compendial and non-compendial waters. These concepts include specification, design, installation, operation, testing, validation and maintenance of components and systems.

Participants will examine methods for proper water quality selection and receive detailed guidance regarding the choice and use of appropriate construction materials and instrumentation. The course also reviews both US and European regulatory requirements (Compendia, current Good Manufacturing Practices and Regulatory Guides) and explores typical concerns of the Regulator.

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.

Participants will receive a complimentary copy of the Water and Steam Systems Baseline® Guide and the Good Practice Guide: C&Q of Water and Steam.

Webinar Objectives

• Discuss regulatory requirements, current FDA views and current Good Manufacturing Practices (cGMPs) 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 systems

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
  

Includes Webinar

This course includes a pre-recorded Webinar that provides a review of the basics prior to the classroom course. You will receive information via email on how to access the Webinar two weeks prior to the start of the training event.

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 mailed within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.