Water System Validation for Microbiologists

What you'll be able to do

• ✓ State PW and WFI quality requirements and production options
• ✓ Recognise design features that prevent microbial growth
• ✓ Plan URS, DQ, IQ, OQ and PQ for a water system
• ✓ Run the three-phase PQ and set alert and action levels
• ✓ Sample and test water correctly, including R2A and endotoxin
• ✓ Control biofilm, validate sanitisation and investigate excursions

Syllabus

1. MODULE 1Requirements and designWater grades and design for control.

   • Water grades and what the system must deliverFree preview
   • Design for microbial controlFree preview
2. MODULE 2ValidationLifecycle and the three PQ phases.

   • The validation lifecycle
   • PQ in three phases
3. MODULE 3Routine controlSampling, sanitisation and trending.

   • Sampling and testing
   • Biofilm and sanitisation
   • Trending, excursions and case studies
   • Final exam (25 questions)

Questions