Best Practices for Cleaning Validation Program

This course provides practical guidance on cleaning validation regulatory compliance, in conjunction with process validation principles to facilitate reasonable and informed decision making and activity planning.  Regulatory requirements and the latest industry practices will be included in the discussion to identify questionable practices that may be misdirected as well as the better practices that support and align with current process validation principles. The program will describe a risk-based approach for establishing an effective cleaning validation program, including the development of policies, master plans and the appropriate content for each study to be performed incorporating critical quality attributes and critical process parameters and process control. In addition, validation maintenance and life cycle aspects will be reviewed. Cleaning validation examples will be included from different sterile and non-sterile product types, and different types of dosage forms including oral, topical, and injections. Concepts will apply to any FDA regulated manufacturing including drugs, supplements, personal care, medical devices. Additional benefits of this class include interacting and learning from peers. Participants will have the opportunity to discuss their challenges and problems.

Additional benefits of this class include interacting and learning from peers. Participants will have the opportunity to discuss their challenges and problems.

Steven A. Weitzel is Vice President-Technical Operations of CANI, Inc. Critical Process Cleaning.  He is a recognized subject matter expert on process development and on validation of cleaning and contamination control for FDA regulated manufacturing, including sterile and non-sterile drug dosage forms, biologics, APIs, devices and combination products, cosmetic and consumer products, and emerging natural medicines and supplements., He has conducted technical training or consulted for the world’s leading pharmaceutical, biotech, cosmetic and medical device companies.  He primarily works in North America and Europe, but his work has extended to the Middle East, India and Southeast Asia within companies of all size and structure.

Mr. Weitzel earned a B.S. in chemical engineering from the University of Missouri, and a Master’s in Business Administration from Washington University in St. Louis.  He is a pharmaceutical process engineer with over 25 years technical experience in FDA regulated industry, holding technical and management positions at Novaflux, Bristol-Myers Squibb, Calgon-Vestal/Merck, Mallinckrodt, and Dow Chemical with direct experience in engineering, manufacturing and validation of medical devices and in-vitro diagnostics, APIs, oral drugs and nutritionals, terminally sterilized and aseptic parenterals.  While at Calgon-Vestal/Merck (now Steris) he started their business life science business unit and introduced CIP 100 and other cleaning agents for validated cleaning as well as LpHst, Spor Klenz and products and support for aseptic manufacturing.  Mr. Weitzel has been involved in hundreds of facilities, projects and applications related to critical systems, contamination control, cleaning or process validation..

Current responsibilities include external technical support and technical marketing for CANI process cleaning agents, vapor decontamination of rooms and vessels, and two-phase flow cleaning for piping and membranes.  He also manages all internal technical operations -manufacturing, validation and quality systems.  The capability to do validated CIP and SIP with 60-90% reduction in water and waste is his current technical emphasi.

Mr. Weitzel is a frequent industry trainer and is consulted regarding process validation and validation master plans; risk evaluation methods and tools; risk-based microbial control and environmental monitoring; aseptic manufacturing; critical cleaning and cleaning validation; continuous process improvement and change control.  He has been involved in several professional organizations including PDA and ISPE, serving on technical, training and policy committees.