Basic Principles of Cleaning Validation: 2-Day In-Person Seminar

Cleaning validation programs for pharmaceutical firms are a regulatory expectation. The FDA, Health Canada, WHO and other regulatory agencies have published their expectations for a good cleaning validation program. There are also numerous textbooks, articles, and other helpful resources such as PDA’s Technical Report #29 (Revised 2012) “Points to Consider for Cleaning Validation”. The risk-based regulatory initiatives of the FDA focus new attention on the risks of cross-contamination. Some firms have highly potent molecules in their product mix. Advanced analytical methods are emerging with promises to detect molecules to the ppb levels. Understanding and implementing new technologies and principles pause challenges to a cleaning validation specialist to establish, manage and maintain a scientifically sound cleaning validation program.

This two day interactive course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors.

Upon completing this course on cleaning validation, participants will understand:

• Regulatory requirements for cleaning validation
• Fundamentals of cleaning validation
• How to develop master plans
• SOP development
• Equipment characterization
• How to differentiate the requirements for cleaning validation when using manual, semi-automatic, and automatic cleaning technologies
• How to identify and characterize potential residues including product, process and cleaning agents
• How to conduct lab scale studies to determine best cleaning conditions
• Cleaning chemistry and selection of suitable cleaning agents
• How to validate/qualify analytical and microbiological methods
• How to perform recovery studies
• Engineering studies and cycle development
• How to calculate acceptance limits that meet regulatory expectations
• Family/grouping approaches for equipment/product
• How to determine suitable sampling techniques and the selection of sampling locations
• Developing cleaning validation protocols
• Collecting and testing validation samples
• Developing validation reports
• How to investigate and find root cause for failures
• Life cycle management and monitoring programs

Attendees will be able to practice through hands-on exercises.

This course is designed for professionals responsible for all aspects of cleaning validation programs, including development, deployment, and maintenance. Following personnel will benefit from the course:

• Quality assurance specialists
• Quality control technicians
• Validation scientists
• Validation service personnel
• Production supervisors
• Manufacturing engineers
• Design engineers
• Technical support personnel
• Engineers supporting the cleaning validation program
• All levels of management who need to understand the science of cleaning and cleaning validation