This 2-day course is particularly relevant to managers, supervisors, and operatives taking on new responsibilities related to water, but also for experienced water personnel to learn the true whys behind what they do and perhaps better ways of doing things.
Specific positions that will benefit:
- Microbiology Laboratory supervisors and analysts responsible for water sampling and testing
- Quality Assurance personnel responsible for water system deviation management and change control
- Regulatory and Compliance professionals responsible for FDA interactions
- Process and Utility Engineers responsible for water system maintenance, troubleshooting, and excursion mitigation
- Facility Engineers responsible for water system design or renovation
- Validation personnel for water system qualification
- Understand the role of system design, maintenance and sanitization in controlling microbial levels in pharmaceutical water systems.
- Successfully troubleshoot problems resulting from poor design/maintenance versus sampling or testing problems.
- Devise water system validation protocols that truly validate microbial control.
- Validate their water microbial test method.
- Develop sound Alert and Action Levels and Water Specifications.
- Defend their test method, in-process control levels and specifications to FDA.
Day 01 (8:30 AM - 4:30 PM)
Registration Process: 8:30 AM - 9:00 AM
Session Start Time: 9:00 AM
Basics of Water System Biofilm Control by Design & Operation
Successful Water System Sanitization
Common Sense Water System Validation
Understanding and Controlling Endotoxin
Harmonizing vs Optimizing Water Microbial Testing for System Quality Control
Day 02 (8:30 AM - 4:30 PM)
Microbial Enumeration Issues with High Purity Water Systems
Reducing Water Microbial Excursions & Improving Investigations
Water System Investigation "How-To's" and Example Case Studies
Leadership in Mfg Contamination Control: The Microbiology Lab
USP Chapter : What USP Says about PW, WFI, Pure Steam & Micro Issues
Guarding Against Common Pharmaceutical Water System Inspection Pitfalls
For more information about this conference visit http://www.researchandmarkets.com/research/m8l3cq/the_a_to_zs_of