Cleaning Validation Best Practices for Drugs, Biologics and Personal Care Products 2026

Cleaning Validation Best Practices for Drugs, Biologics and Personal Care Products is organized by The Center for Professional Innovation & Education (CfPIE), Inc. and will be held from Nov 09 - 10, 2026.

Description
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. 

Learning Objectives:
By the end of this course attendees will:

• Understand the importance and underlying principles of validation of cleaning procedures for manufacturing equipment 
• Understand the FDA requirements and perspectives on cleaning validation and areas of regulatory concern during inspections and identify gaps in their own programs
• Be able to set up cleaning validation practices, procedures, protocols and reports that meet current FDA, WHO, PIC/S and EU regulations and align with current process validation principles including understanding of critical process parameters, sources and control of variability, process monitoring and control scheme. 
• Be able to develop and defend your own rigorous but pragmatic cleaning validation approach to avoid costly rejections by regulatory agencies, but also avoid unnecessary activities and overkill.