Aseptic Processing and Validation 2019 is a conference dedicated to overview of the requirements for aseptic and bulk manufacturing operations.
Aseptic Processing and Validation 2019 covers topics such as:
- 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
Aseptic Processing and Validation 2019 brings together:
- 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
