Good Cleaning Validation Practices
Seminar Agenda
May 12, 2008
REGISTRATION / CONTINENTAL BREAKFAST
MORNING SESSION
Welcome and Introductory Remarks
Cleaning Validation Defined
Cleaning Validation History
Setting Residue Limits
Basic calculations
Rinse calculations
Additional considerations
AFTERNOON SESSION
Setting Residue Limits (continued)
Cleaning agents
API’s
Clinical trial materials
Biotechnology
Indirect product 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, 2008
MORNING SESSION
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
Dedicated equipment
Campaigns
Master plans
LUNCH
AFTERNOON SESSION
Validation maintenance
Monitoring
Preventive maintenance
Change control
Deviations
Revalidation
Regulatory guidance documents
FDA
PIC/S
ICH Q7A
Other documents
Questions & Answers