Storage Delivery and Qualification of Pharmaceutical Waters (T23)

Level: Intermediate/Advanced
ISPE CEUs: 1.3
Type: Classroom Training Course

You might also be interested in the Pharmaceutical Water Generation training course.

Description

This course will explore the essential concepts and principles of specification, design, commissioning / qualification of equipment and systems used to store and distribute water in pharmaceutical manufacturing. The 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, laboratory water androuging. The course material will cover methods for determining the appropriate distribution and storage strategy, including sanitization method, for various operating circumstances including 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.

Traditional and risk-based approaches to pharmaceutical water system commissioning, verification, and qualification 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, Operational, and Performance Qualifications. Sampling programs for qualification and normal operation will be discussed.

Course Modules

• Planning & Programming
• Storage & Distribution Sanitization and Microbial Control
• Storage & Distribution Configurations
• Storage and Distribution Design
• Laboratory Water Storage and  Distribution
• Commissioning, Qualification & Validation
• Rouge and Stainless Steel
• Appendices

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 and overall system construction
• Integrate commissioning and validation activities
• Streamline the validation process

Attendance Recommended For

• Quality assurance specialists, quality control technicians, regulatory affairs professionals, pharmacologists and toxicologists, validation scientists, and validation service personnel.
• All levels of management who need to understand the aspects of residue selection, sampling method and analytical detection method validation, limits determination, and strategies for managing multi-product facilities.
• Those with significant pharmaceutical water experience who want understand current industry trends and ISPE consensus views.
• Those who want the ability to defend and critique design, operation and maintenance practices.

Community of Practice (COP)

This training course is of particular interest to existing and future members of the ISPE Critical Utilities Community of Practice (COP).

CPIP™ Technical Knowledge and Competency Elements

This course contains knowledge related to the CPIP™ technical knowledge competency elements Facilities and Equipment: Design and Construction / Installation and 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.

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.