PDA Aseptic Processing-Sterilization Conference 2013
June 20 - 21, 2013
シカゴ IL , 米国
The 2013 PDA Aseptic Processing-Sterilization Conference will bring together all levels of industry professionals and regulators to network and benefit from a program that will explore new and improved best practices and strategies for sterile product manufacturing technologies.
This two-day conference will provide participants with a comprehensive review of contemporary practices for the conduct of terminal sterilization and aseptic processing with special emphasis on state of the art approaches, process simulation, risk assessment/mitigation, and parametric release.
The complete program agenda will include presentations from regulatory and industry representatives from around the world who will share current expectations, recent case studies, current and future trends.
During the conference, PDA will host an exhibition of leading bio/pharmaceutical companies who will showcase new technologies and trends.
Learning Objectives
At the completion of this conference attendees will be able to:
• Describe the latest methods for aseptic risk evaluation
• Identify the changes in PDA's TR #22 - Process Simulation for Aseptic Processing
• Explain the benefits associated with post-aseptic fill lethal treatments
• Discuss regulatory risk perspectives and implications for aseptic processing
• Identify contemporary aseptic processing technologies for risk minimization
• Give examples of best practices for steam-in-place
Who Should Attend
Departments
Manufacturing | Formulation | Compliance | Engineering | QA/QC | Development | Regulatory Affairs | Research and Development | Technical Operations | Validation
Level of Expertise
Senior Management | Senior Scientists | Project/Program Leader | Technical Contributor
Job Function
Microbiology | Validation | Engineering | Quality | Regulatory | Sterility Assurance | Sterile Operat
This two-day conference will provide participants with a comprehensive review of contemporary practices for the conduct of terminal sterilization and aseptic processing with special emphasis on state of the art approaches, process simulation, risk assessment/mitigation, and parametric release.
The complete program agenda will include presentations from regulatory and industry representatives from around the world who will share current expectations, recent case studies, current and future trends.
During the conference, PDA will host an exhibition of leading bio/pharmaceutical companies who will showcase new technologies and trends.
Learning Objectives
At the completion of this conference attendees will be able to:
• Describe the latest methods for aseptic risk evaluation
• Identify the changes in PDA's TR #22 - Process Simulation for Aseptic Processing
• Explain the benefits associated with post-aseptic fill lethal treatments
• Discuss regulatory risk perspectives and implications for aseptic processing
• Identify contemporary aseptic processing technologies for risk minimization
• Give examples of best practices for steam-in-place
Who Should Attend
Departments
Manufacturing | Formulation | Compliance | Engineering | QA/QC | Development | Regulatory Affairs | Research and Development | Technical Operations | Validation
Level of Expertise
Senior Management | Senior Scientists | Project/Program Leader | Technical Contributor
Job Function
Microbiology | Validation | Engineering | Quality | Regulatory | Sterility Assurance | Sterile Operat
開催地
Location: Hyatt Chicago Magnificent Mile関連イベント
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