Environmental Monitoring Training Course
Novatek International and MicroRite Inc.

Novatek International and MicroRite Inc. have joined together to bring you a workshop on Intensive Training In Environmental Monitoring, Disinfectant Qualification and Cleanroom Contamination Control taking place at the Renaissance Toronto Airport Hotel & Conference Centre from June 26 to 27, 2008 in Toronto, Canada.

Topics include:

• Discussion on the various cleanroom classification schemes and Environment Monitoring regulations and guidances
  
• Guidance on setting up a meaningful Environmental Monitoring plan including number and location of sites
  Microbial Identification, when it is necessary and why
  
• Discussion on choice and evaluation of equipment for Environmental Monitoring
  
• Establishing User Requirements for Electronic Environmental Monitoring Program
  
• Using Novatek’s EM Software Module learn how to create a plan to track and trend EM data
  
• When and why to identify EM isolates
  
• Discussion on evaluation of microbial identification systems
  
• Guidance on trending EM data using Excel and Novatek System in order to retrieve important information on the condition of the manufacturing facility
  
• Overview of the key components of EM Summary Reports that will provide rapid review of EM controls and precisely relate this to the manufacturing facility condition
  
• Environmental Monitoring related investigations, what and where to look for
  
• How to evaluate automated systems for Environmental Monitoring
  
• Discussion on FDA 483 observations on environmental monitoring and data trending
  
• Detailed discussion of bacterial and fungal contamination in cleanrooms, their source and quantities
  
• Disinfectants commonly used, their modes of action, efficacy, and toxicity
  
• Create your own plan, use your environmental monitoring data to choose the disinfectants and cleaning frequencies
  
• Discussion on current methods used in the industry to qualify disinfectants-What is expected from regulatory agencies and who should qualify disinfectants
  
• Tools to develop an effective disinfectant qualification program
  
• Commonly observed deficiencies in Disinfectant Qualification studies that may lead to contamination or FDA observations
  
• Translation of disinfectant qualification results to cleaning procedures to prevent contamination
  
• Learn how to use Environmental Monitoring Data Trends to evaluate cleaning efficacy
  
• Discussion on FDA 483 observations related disinfectant qualification and cleaning procedures
  
• Case studies where errors in choice of disinfectants or disinfectant qualification have lead to major contamination issues

To find out more and to register for the course, click here.