Aseptic Processing and Validation 2019

Aseptic Processing and Validation 2019 is a conference dedicated to overview of the requirements for aseptic and bulk manufacturing operations.

Topics

• What the Food and Drug Administration (FDA) expects of an aseptic filling operation including key differences in other regulated markets
• Fundamental aseptic facility design principles
• How to properly check equipment and systems in preparation for processing via process simulations media fills
• Aseptic container-closure systems and leak testing
• The importance of an environmental monitoring program
• The difference between aseptic processing and terminal sterilization
• Risk management strategies to aseptic operations
• The technical fundamentals behind filter sterilization
• The difference between isolators and barriers
• Be in a better position to your clean room operations
• Autoclave cycles and microbiological lethality
• Lesser-used techniques in aseptic processing
• Gamma and beta radiation sterilization
• Dry heat sterilization and depyrogenation
• The basics of lyophilization freeze drying
• Ethylene oxide sterilization
• The various types of pharmaceutical water, including water for injection; pure steam generators
• Where cleaning validation fits in
• Practical tips on how to manage your aseptic operations
• How validation concepts are inter-woven

Who should Attend

• Quality Control Department Management and Staff
• Quality Assurance Department Management and Staff
• Records Managers
• Operations Department Management and Staff
• Engineering Department Management and Staff
• Production Management and Staff
• Facilities / Maintenance Management and Staff
• Validation Management and Staff