The Hero of Manufacturing Contamination Control - The Microbiology Lab 2012

Topics

• Routine contamination evaluation activities
  
  • Environmental monitoring
  • RM and Product testing
  • Sanitizer and disinfectant evaluations
  • Water, steam, and compressed gas monitoring
• Why the microbiology lab must lead in contamination control
  
  • Lab uses tools and techniques able to assess contamination and sources
  • Lab personnel have microbiological knowledge and expertise, QA usually doesn`t
  • Lab uses appropriate controls to detect and prevent testing problems
• Root cause microbial contamination investigations
  
  • Ability to withstand production pressure for hasty, potentially faulty conclusions
  • Ability to interpret investigation data and microbial impact
  • Truly understand cause(s) of problem so can derive effective CAPA
• Microbiological awareness/aseptic process training for operators
• Microbiological conscience for the company

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
• Consultants and Troubleshooters
• QA managers and Regulatory Affairs personnel involved in defending water system operations and quality data to FDA and EMEA inspectors and outside auditors