PTI - international

Agenda: Day One

• Review the history and evolution of cleaning validation
• Define key terminology and acronyms
• Identify key components of a cleaning validation
• Outline the cleaning validation lifecycle

Discussion: Review Participants' Backgrounds and Experience with Cleaning Validation
Exercise: What is Clean?

II. Comply with Regulatory Requirements for Cleaning Validation

• Review GxPs as related to cleaning validation
• Clarify and comply with FDA and EU requirements and industry standards
• Interpret inspection guidelines related to cleaning
• Assess latest regulatory trends and issues
• Establish "worst case" situations for shared equipment and products
• Determine the different requirements for medical device, biotech and pharmaceutical products

Exercise: Critique Sample 483s and Warning Letters to Identify Common Enforcement Trends

III. Settings Limits for Allowable Carryover

• Identify possible sources of contamination or residues
• Calculate scientifically justifiable residue limits
• Determine the relationship between maximum allowable carryover (MACO) and minimum allowable detection limit (MADL)
• Learn how to calculate limits for residues of cleaning agents and other non-therapeutic residuals
• Use "visually clean" as cleaning criteria

Exercise: Calculate Limits for Products Residuals

IV. Sample and Test Cleaning Samples

• Become familiar with the different types of sampling techniques
  • swab sampling
  • rinse sampling
  • identify the advantages and disadvantages of the different types of sampling
  • become familiar with the concept of sampling technique and its importance
• Identify analytical methods most appropriate for cleaning samples
• Determine which analytical methods may be appropriate for different given testing situations
  • Semi-automated cleaning (COP):
  • Familiarize yourself with the concepts of analytical methods validation

Exercise: Select Appropriate Analytical Methods for Test Cases