Benchmark for Cleaning Validation 2015

Topics

• Pre-validation activities including defining worst case challenge to the process and selecting cleaning agents
• Sterilization process description and validation options including the kinetics of lethality (bioindicator vs bioburdens) and test methods
• Sources of process variation and basics of process control
• Aspects to consider when writing the validation protocol
• Post-validation (re-validation) and change control
• Data collection and troubleshooting
• Reporting and documentation requirements

Who should Attend

• Manufacturing Managers and Engineers
• QA Managers and Engineers
• Quality System Auditors
• Consultants
• Executives and Managers responsible for validating cleaning or sterilization processes