Cleaning Validation Technologies

Destin A. LeBlanc-Technical Consulting Services

GOOD CLEANING VALIDATION PRACTICES AGENDA


MAY 12, 2015

EVENT Time

Registration-Continental Breakfast 8.15-9.00

Morning Session 9.00-12.30

  • Welcome and Introductory Remarks
  • Cleaning Validation Defined
  • Design/Development of a Cleaning Process
  • Setting Residue Limits
  • Basic Calculations
  • Rinse Calculations
  • Health-based Limits

Lunch 12.30-1.30

Afternoon Session 1.30-5.00

  • Setting Residue Limits (continued)
  • API's
  • Clinical trial materials
  • Biotechnology
  • Indirect produce contact surfaces
  • Visual inspection
  • Non-uniform contamination
  • Microbial limits
  • Analytical Methods to Measure Residues
  • Specific methods
  • TOC
  • Newer methods
  • Blanks and controls
  • Method validation

MAY 13, 2015

Continental Breakfast 8.15-9.00

Morning Session 9.00-12.30

  • Sampling Methods
  • Direct surface
  • Swab sampling
  • Site selection
  • Rinse sampling
  • Sampling recovery
  • Protocols
  • Protocol parts
  • Worst cases
  • Dirty equipment hold time
  • Validation Strategies
  • Existing processes
  • Grouping strategies
  • Clean equipment hold time
  • Verification
  • Dedication equipment 
  • Campaigns
  • Master Plans

Lunch 12.30-1.30

Afternoon Session 1.30-5.00

  • Validation Maintenance
  • Monitoring 
  • Preventive maintenance
  • Change control
  • Deviations
  • Revalidation
  • Regulatory Guidance Documents
  • FDA
  • PIC/S
  • ICH Q7A
  • Other documents
  • Questions and Answers

Adjournment