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Date: 12th - 13th May, 2008

Location: Dublin, Ireland

Summary:
Pharmaceutical - Training, Seminar

Who Should Attend

This is a two-day course for people who need to understand the technical fundamentals of aseptic processing or who are responsible for aseptic operations in a lab, pilot or commercial setting. The course is ideally suited to industrial microbiologists, scientists and engineers either with technical or managerial responsibilities in the biotechnology and pharmaceutical industries.

Learning Objectives

During and upon completion of this course, you will:

• Understand fundamental aseptic facility design principles
  
• Appreciate what the Food and Drug Administration (FDA) expects of an aseptic filling operation including key differences in other regulated markets
  
• Better understand aseptic container-closure systems and leak testing
  
• Know how to properly check equipment and systems in preparation for processing via process simulations - media fills
  
• Learn the difference between aseptic processing and terminal sterilization
  
• Learn about the importance of an environmental monitoring program
  
• Understand the technical fundamentals behind filter sterilization
  
• Begin to apply risk management strategies to aseptic operations
  
• Be in a better position to manage your clean room operations
  
• Appreciate the difference between isolators and barriers
  
• Know more about lesser-used techniques in aseptic processing
  
• Understand autoclave cycles and microbiological lethality
  
• Know about dry heat sterilization and depyrogenation
  
• Understand gamma and beta radiation sterilization
  
• Learn about ethylene oxide sterilization
  
• Know the basics of lyophilization - freeze drying
  
• Be introduced to radiopharmaceuticals
  
• Learn where cleaning validation fits in
  
• Learn about the various types of pharmaceutical water, including water for injection; pure steam generators
  
• Understand how validation concepts are inter-woven
  
• Receive practical tips on how to manage your aseptic operations