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Good Cleaning Validation Practices – 24th – 25th October 2011 Istanbul

 

This cleaning validation training addresses cleaning validation from a life cycle perspective. There is more than one way to achieve a compliant cleaning validation program.

Destin A. Le Blanc provides insights related to understand the cleaning process in a specific situation so effective and efficient programs can be established and executed.

At the end of the course 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 process

Who Should Attend

Professionals responsible for various aspects of cleaning validation including:

  • Validation scientists
  • Validation service personnel
  • Production engineers
  • Quality assurance specialists
  • Quality control technicians
  • Analytical chemists
  • Microbiologists
  • Regulatory affairs professionals
  • Pharmacologists
  • Toxicologists
  • Technical support scientists
  • Supervisors, managers and directors of groups supporting cleaning validation

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