Good Cleaning Validation Practices

Seminar Objectives

At the end of the seminar on Good Cleaning Validation Practices, participants should be able to understand and apply:

• USA and European cleaning validation guidance documents

• Principles and calculations of residue limits for a wide variety of residue types, routes of administration, and dosage types

• Selection of analytical methods, along with appropriate levels of analytical method validation

• Selection of sampling methods and sampling sites, along with proper selection of blanks and controls

• Appropriate strategies and documentation for sampling recovery studies

• Cleaning validation master plan and/or policy components

• Strategies to simplify validation protocols and validation implementation

• Strategies for grouping to simplify validation

• Appropriate documentation for cleaning validation protocols and reports

• Monitoring, revalidation and validation maintenance for validated cleaning processes