Using ICH Q9 and Recent FDA Comments as the Foundation for the Planning, Development and Execution of Risk-Based Cleaning Validation Studies

This Cleaning validation training will provide valuable assistance to all regulated companies that need to develop and validate their equipment cleaning processes. This session will address risk-based approaches to cleaning validation studies using ICH Q9 and recent FDA comments and observations as a foundation. Recent FDA warning letters illustrate just how critical good cleaning practices are. Understanding and employing good cleaning practices are instrumental to improving cleaning consistency, quality and traceability. The FDA favors automated CIP systems since they reduce operator variability while enhancing consistency and reproducibility. Our research has indicated that in the last 5 years, cleaning citations were noted in 50% of warning FDA letters. Many cited contamination issues have an element of poor cleaning practices associated with them. Examples include “investigations…did not include an evaluation of the cleaning processes and procedures…to determine if equipment cleaning is effective in preventing cross contamination of the inactivated batches”, FDA Warning Letter, Jan 2008; 'vaccine manufacturing plant in Pennsylvania, has been served with an FDA warning letter asking for measures to ensure batches of its flu shot ingredients do not become contaminated again.” Jul-2006..

An overview of ICH risk management techniques and how to apply them to equipment cleaning programs will be discussed. In addition, case studies from manufacturing facilities will be used to illustrate risk-based cleaning validation principles and practices.

Areas Covered in the seminar:

• Review of industry current best practices and future trends for cleaning validation studies.
• Review of ICH Q9 content with respect to cleaning validation.
• Presentation of practical cleaning validation risk analyses and management tools.
• Review of recent FDA comments and observations on risk-based validation.
• Evaluation of the role of PAT in risk-based cleaning validation studies.
• Review of Statistical Process Control (SPC) methodologies for ongoing monitoring of cleaning operations.

Who Will Benefit:

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This webinar will provide valuable assistance to all regulated companies that need to develop and validate their equipment cleaning processes, including companies in the Biopharmaceutical, Pharmaceutical and Medical Device fields. The employees who will benefit include:

• Quality Assurance professionals and mangers
• Validation professionals, practitioners and mangers
• Operations professionals and mangers
• Engineering professionals and managers
• Regulatory professionals