Location: Philadelphia, PA
STERIS will be a part of this two-day summit focusing on science, risk and statistics-based cleaning validation – designed to help you and your company to start implementing industry regulations for ADE Monographs and Risk Assessments of Cleaning Validation Programs.
Comprehensive Coverage on:
–ASTM Standard on Science and Risk-Based Cleaning Process Development and Validation
–Case Study for Low-Risk Manufacturing
–ASTM Standard on Derivation of Health Based Exposure Limits (ADEs/PDEs)
–How to use ADEs/PDEs for Setting Cleaning Acceptance Limits
–ASTM Standard for Validating Cleaning Processes Used During the Manufacture of Medical Devices
–Upcoming ASTM Cleaning Standards Covering both Drugs and Devices
–Automation for Rapid Cleaning Process Development
–Application of Risk Assessments to Cleaning Processes
–Risk-based Selection of Analytical methods
–Risk-based Implementation of Total Organic Carbon Analysis (TOC)
–Application and Qualification of Visual Inspection
–Identification of Unknown Residues Found in Cleaning Validations
–Statistical Evaluation of Cleaning Validation Data
–Application of Bayesian Statistics to Cleaning
See STERIS at the event:
Wednesday, September 12
4:20PM || Designing an Effective Cleaning Program
Presented by: Beth Kroeger, STERIS Technical Service Manager
Description: An important aspect of any Cleaning Validation program is selection of the cleaning agent. Selection is based on many factors such as equipment design, residue selection, soiling conditions, and cleaning parameters available. Most importantly, cleaning agents should meet the requirements of a cGMP regulated industry. Appropriately selecting a cleaning agent that considers the factors influencing cleaning and is validatable could simplify Cleaning Validation activities for a new process and the lifetime of the product.
5:00pm || Happy Hour
STERIS is honored to sponsor the complimentary welcome reception happy hour, we hope to see you there as we kickoff the Cleaning Validation Summit!
Thursday, September 13
1:50PM || Cleaning Development; Using a Quality by Design Approach to Stop Cleaning for Long Hours
Presented by: Walid El Azab, STERIS Technical Service Manager
Description: The presentation will share a systematic cleaning development method to a science and risk-based approach for product residue cleaning. The following concept will be discussed during the presentation: determination of the cleaning critical parameter, critical quality attribute, the design of space, and cycle development. The understanding of this concept is crucial to implementing effective cleaning processes and avoid complex cleaning process and long cleaning times. During the presentation – different tools, case studies, and lessons learned will be shared to demonstrate the benefit of a robust cleaning development.