Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems 2013

Key Topics

• Water system dilemma: process control or quality control (utility or raw material), or both
• What are excursions?
• Investigation, necessary and often fruitless
• Intended functions of Alert/Action Levels and Specifications
• Criticality of valves, hoses, & outlet flushing
• Excursion responses and impact
• Minimizing unnecessary excursion responses through best practices
• Diagnosing the source of the problem

Who should Attend

• QC managers and personnel involved in sampling, testing, and trending chem and micro data from water systems
• QA managers and personnel involved in investigations of excursions and preparing CAPAs
• Validation managers and personnel
• Utility operators and their managers involved in maintaining and sanitizing water systems
• QA managers and Regulatory Affairs personnel involved in defending water system operations and quality data to FDA and EMEA inspectors and outside auditors
• QA managers and other personnel involved in Change Control programs
• Consultants and Troubleshooters