Pharmaceutical Water Operation: Storage, Distribution, System Operation and Validation
ISPE CEUs*: 1.3
Type: Classroom Training Course
Dates and Locations
|
Date |
Location |
Country |
Instructor(s) |
|
24-25 September 2008 |
New Jersey Classroom Training Series |
United States |
Description
This course will explore the fundamental concepts and principles of specification, design, installation, operation, testing, and maintenance of equipment and systems used to store and distribute water in pharmaceutical manufacturing, as well as elements of system validation. The course material will cover methods for determining the appropriate distribution and storage methodology for various operating circumstances. The course will provide an overview of optional distribution approaches and the advantages and disadvantages of each. Microbial control characteristics of the various distribution systems will be presented and compared. Point-of-use service and sample point design, materials of construction for distribution and storage systems, and instrument components will also be covered.
Emphasis will be placed on operational and maintenance issues such as system testing and sampling for regulatory compliance. Participants will discuss preventive maintenance (including cleaning and sanitization), troubleshooting of storage and distribution systems, and will receive guidance for setting up and maintaining sampling and monitoring programs during ongoing operation as well as during initial system qualification.
Traditional and risk-based approaches to pharmaceutical water system commissioning, verification, and validation will be explored. System and component level impact assessments will be covered as well as identifying critical process parameters and critical quality attributes. The overall validation lifecycle for pharmaceutical water systems will be explored including the details of Installation, Operational, and Performance Qualifications.
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.
This course contains knowledge related to the CPIPSM technical knowledge competency elements Facilities and Equipment and Production Systems. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ISPE-PCC.org.
Take Back to Your Job
- Differentiate regulatory requirements from regulatory myths relative to water distribution and storage systems
- Identify the alternative designs for storage and distribution systems and the advantages and disadvantages of each
- Analyze 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 commissioning and validation activities
- Streamline the validation process
Attendance Suggested For
- 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.
- Those with significant pharmaceutical industry experience in a non-water system capacity who now have water 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.
- 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.
- This training course is of particular interest to existing and future members of the ISPE Critical Utilities Community of Practice (COP).
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.