Overview

Level: Fundamental/Intermediate 

Type: Certificate 


ISPE Continuing Education Units (CEUs): 2.8

The Pharmaceutical Water Systems certificate program provides comprehensive training on the generation, validation, storage and delivery, and ongoing operation and maintenance of water systems crucial to pharmaceutical manufacturing. This program is designed for professionals in the pharmaceutical and biopharmaceutical industries, focusing on the critical aspects of water system design, maintenance, and regulatory compliance.

Benefits:

• Enhanced Expertise:
  • Gain specialized knowledge to design, operate, and maintain pharmaceutical water systems, ensuring high standards of quality and compliance.
• Regulatory Compliance:
  • Learn the latest regulatory guidelines and best practices to keep your water systems in compliance with international standards.
• Operational Efficiency:
  • Implement efficient water generation, storage, and delivery systems to optimize operational processes and reduce downtime.
• Risk Mitigation:
  • Understand how to develop risk assessments, and to identify, as well as mitigate risks associated with pharmaceutical water systems, ensuring product safety and quality.  
• Professional Development:
  • Advance your career with in-depth training from industry experts, enhancing your professional qualifications and capabilities. 

This program is essential for engineers, quality assurance professionals, and anyone involved in the design, operation, or validation of pharmaceutical water systems. By completing this certificate program, participants will be equipped with the knowledge and skills necessary to ensure the highest standards of water quality in pharmaceutical manufacturing.

Certificate Curriculum

Key Takeaways

• Water Generation
  • In-depth understanding of water generation technologies, including reverse osmosis (RO), electrodeionization (EDI), and distillation
  • Knowledge of various types of pharmaceutical water, such as purified water (PW) and water for injection (WFI) based upon current industry regulation, cGMP design and operational considerations and current industry trends
  • Best practices for designing and operating water generation systems to ensure consistent quality
• Storage and Delivery
  • Insights into effective storage solutions to maintain water quality
  • Techniques for designing distribution systems that prevent contamination and maintain the integrity of water quality
  • Comprehensive guidance on piping, materials, and system components to ensure reliable water delivery
• Qualification and Validation
  • Traditional and risk-based approaches to validation
  • Detailed procedures for qualifying water systems to meet regulatory requirements
  • Strategies for conducting validation studies, including performance qualification (PQ), installation qualification (IQ) and operational qualification (OQ)
  • Understanding of documentation and compliance standards set by regulatory bodies such as the US Food and Drug Administration (US FDA) and European
  • Medicines Agency (EMA) with a heavy emphasis on sampling plan development and execution 

Program Format  

 The instructor-led courses will be presented through lectures, articles, and videos, with interactive breakout sessions, polls, team activities and exercises reflecting current pharmaceutical industry requirements.

Course Modules

• Pharma Water Generation USP WFI and Purified Water
  • Introduction and Regulatory Background
  • Planning and Programming Water Systems
  • Basic Water Chemistry Concepts
  • Water Systems Microbial Considerations
  • Feed Water Characterization
  • Basic System Review
  • Pretreatment Systems
  • Reverse Osmosis Theory and Design
  • Deionization Processes
  • Processes: Ultraviolet (UV), Membrane Vacuum Degasification (MVD), Ultrafiltration (UF), and Microfiltration (MF)
  • Distillation
  • Purified Water Systems
  • Water for Injection Systems
  • Non-compendial System Design  
  • Water for Laboratory Use
  • Pharmaceutical Steam
  • Appendices
  • Exercises
• Storage, Delivery, and Qualification of Pharma Water 
  • Regulatory Overview
  • Planning and Programming
  • Storage and Distribution Sanitization and Microbial Control
  • Storage and Distribution Configurations
  • Storage and Distribution Design
  • Laboratory Water Storage and Distribution
  • Commissioning, Qualification, and Validation
  • System Sampling
  • Rouge, Stainless Steel, and Passivation
  • Appendix: Traditional, Risk-Based, and Science-Based Water System Commissioning and Qualification 

Who Should Attend

• Professionals new to pharmaceutical water  
• Those with significant engineering expertise from another industry who need to learn about pharmaceutical water best practices
• 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
• Commissioning and validation engineers with experience in the field but who may be unfamiliar with pharmaceutical water 

Community of Practice (COP)

This training course will be of particular interest to existing and future members of the ISPE Critical Utilities CoP. 

Pricing

Now Your Whole Team Can Participate in an ISPE Learning Experience

• 3 - 5 participants - Save 10%
• 6 - or more participants - Save 20%

Group discount applies to Member/Nonmember rate only. To qualify, all registrant information must be submitted at the same time. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105 or by email, ask@ispe.org.

Cancellations/Refunds

Cancellations must be made in writing. If cancellations are received by 60 days prior to event start date, a full refund, minus a $150 handling fee, will be issued. After that time, no refunds will be granted. Please be advised that if your payment or written cancellation notice is not received prior to the cancellation date, your credit card will be charged the prevailing rate. Refund requests must be in writing and emailed or faxed to +1 (813)-264-2816. (Telephone messages are not accepted). ISPE reserves the right to modify the material or presenters for this event without notice, or cancel an event. If an event must be canceled, registrants will be notified by ISPE. ISPE will not be responsible for airfare penalties or other costs incurred due to cancellation.

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For an enhanced learning experience, ISPE also offers these learning activities as live courses and gives you an opportunity to learn with a live instructor, ask questions, and participate in exercises. View Upcoming Courses