1773 Kings Road, Vista, CA 92084-3640, USA
Tel 1-760-941-2040 or 1-800-698-2040, Fax 1-760-301-0308, e-mail:
info@cce-us.com
Pharmaceutical
Water Systems
Design, Validation,
Operation and Maintenance
A 3-Day Intensive Continuing Education Course 1.8 CEUs)
Course Faculty: Hubert
Fleming, Ph.D.
Course Content:
INTRODUCTION TO WATER
- The Chemistry and Microbiology of Water
REGULATORY STANDARDS FOR WATER
- Compendial vs. Non-compendial Water
- USP Purified Water
- USP Water-for-Injection (WFI)
- The US, EU and Japanese Regulatory Requirements
DESIGN OF WATER PURIFICATION SYSTEMS
- Source Water Requirements
- Treatment Options
- Pre- and Post-Treatment Issues
- Pretreatment and Post-treatment Issues
- Storage and Distribution System Strategies
VALIDATION AND START-UP
- Regulatory Requirements
- Validation Program
- QA Protocols
- System Start-Up
- Sampling and Testing
- Setting of Alert and Action Limits
- Revalidation
OPERATIONAL CONSIDERATIONS
- Operational Parameters
- SOP's
- Preventive Maintenance
- Troubleshooting
- Microbial Control
- Sanitization
EMERGING ISSUES
- New and Upcoming Regulatory Requirements
- Novel Technologies
Copyright Center for Continuous Education
