Good Cleaning Validation Practices
September 26-27, 2011
Dublin, Ireland
A two-day seminar (September 26-27), led by Destin A. LeBlanc, focused on cleaning validation for pharmaceutical manufacturing equipment to meet current GMPs.
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
- Importance of design/development for an effective program
- 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