Cleaning Validation Summit 2022

Our own Michael Moussourakis, Senior Director, Strategic Affairs at Alconox Inc. will be speaking at Cleaning Validation Summit 2022 on Thursday, December 1, 2022 in La Jolla, California.

A brief introduction will be presented reinforcing general cleaning concepts, chemistry and detergency. Aqueous detergent cleaning methods will be reviewed with a detailed focus on manual and clean-out-of-place cleaning methods, associated pros and cons, and equipment. The necessary pre and post cleaning steps, vital to any cleaning application are presented as a lifestyle approach. Their goal being to facilitate cleaning validation programs. This includes needs for focus on set up and procedures before cleaning steps are introduced, during the cleaning process itself, and methods for good practice in post cleaning—long after the final rinse has been completed. Finally, a recent manual cleaning validation of a pharmaceutical product is presented as a case study and reviewed. The requirements, results and procedure followed. The residue detection methods chosen for both residual product and detergent will be discussed.

Overall, the speakers will be discussing:

Can you implement the best science-, risk-, and statistics-based approaches to cleaning validation? Today’s regulators are now expecting ADE monographs and comprehensive risk assessments of your organization’s cleaning validation protocols. Pharma Ed’s Cleaning Validation Summit brings together leading industry experts to illuminate best practices and help you meet regulatory requirements.

Including Coverage On:

• Creating a Robust Cleaning Protocol and Report
• Global Validation and Transfers of mRNA Vaccines
• Lifecycle Management Challenges in Cleaning Verification Analytical Methods
• How to Validate the Manual Cleaning Process
• Manual Cleaning: Best Practices to Optimize the Process and Qualify Your Operators
• Addressing Concerns with Validated Legacy Cleaning Processes
• Answering Frequently Asked Questions from Cleaning Validation Teams
• Risk-based Approaches to Cleaning Validation
• Meeting the New Cleaning Standards for Drugs and Med Devices
• How to Develop a Cleaning Program Based on Hygienic Design and Gap Analysis, Training and Continuous Monitoring
• Maintaining the Cleaning Validated State
• And More!