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