The PDA Risk Management and Aseptic Processing Conference will highlight risk assessment/mitigation for aseptic processing.  The conference will address topics and concerns related to the latest risk management practices and aseptic processing technologies. Plenary sessions will include presentations by regulatory and industry representatives on topics such as:

• Aseptic Risk Assessment modeling alternatives
• Regulatory expectations for Aseptic Processing and Risk Evaluation
• Overview of regulatory and industry guidance documents for Aseptic Processing
• Regulatory initiatives on risk-based compliance
• Case studies of Risk Assessment in Aseptic Processing
• Technology Assessment for Aseptic Processing
• Emerging Technologies for Aseptic Processing Risk Mitigation

Plenary sessions will examine PDA Technical Report No. 22, Process Simulation Testing for Aseptically-Filled Products and the PDA Technical Report on Risk Management of Aseptic Processing. The PDA Training and Research Institute (PDA TRI) will host a pre-conference course, May 13-14, on Elements of Risk Management, to complement what you will learn at the conference.

At the completion of this conference the participant will:

• Describe current methods for aseptic risk evaluation
• Discuss regulatory risk perspectives and implications for aseptic processing
• Identify contemporary aseptic processing technologies for risk minimization
• Explain how aseptic risk management is conducted in other firms and industries

Department
Sterile Operations | Environmental Monitoring | Facility Design and Engineering | Process Development | Compliance / Regulatory | Quality Assurance

Job Function
Technologists | Managers | Directors | Vice Presidents