September 19, 2011 |
Registration – Continental Breakfast |
8:15 – 9:00 |
Morning Session
- Welcome and Introductory Remarks
- Cleaning Validation Defined
- Design/Development of a Cleaning Process
- Setting Residue Limits
- Basic calculations
- Rinse calculations
- Other considerations (genotoxics,
cytotoxics, etc.)
|
9:00 - 12:30 |
Lunch |
12:30 - 1:30 |
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
|
1:30 - 5:00 |
September 20, 2011 |
Continental Breakfast |
8:30 – 9:00 |
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
|
9:00 - 12:30 |
Lunch |
12:30 - 1:30 |
Afternoon Session
- Validation maintenance
- Monitoring
- Preventive maintenance
- Change control
- Deviations
- Revalidation
- Regulatory guidance documents
- FDA
- PIC/S
- ICH Q7A
- Other documents
- Questions & Answers
|
1:30 - 5:00 |
Adjornment |
5:00 |