Cleaning Validation - New Regulatory Expectation & Standards
|Event Date/Time: Mar 09, 2009||End Date/Time: Mar 10, 2009|
|Early Registration Date: Jan 15, 2009|
The program is organized around 4 areas where common industry practice and conventional wisdom is not necessarily best practice or even justified practice for some firms:
1. Beyond MACO (1/000 dose and 10 ppm)- Better practices for risk assessment and justification of cleaning targets and residue limits.
2. Beyond SOPs-Better process understanding with parametric description and control of the cleaning process
3. Beyond Swabbing and HPLC- Better practices for inspection and measurement of cleanliness
4. Beyond â€œ3â€- The CV program as a foundation for ongoing process improvement ( as a â€œjourney, rather than a destinationâ€ )
Conventional cleaning validation practices in these four key areas will be critically evaluated against new regulatory expectations and standards defining cGMPs in light of PAT and Quality Systems concepts.
In addition to presentation of concepts, actual industry examples and references, this will involve a true workshop format with some small group activities and some hands-on work to illustrate issues with current practices or demonstrate better practices. Participant teams will evaluate, weigh alternatives, do calculations and make plans and recommendations. Teams will be provided with spreadsheets and tools they can take with them. You are encouraged to bring a cleaning scenario or problem to the workshop.
You will leave with better rationale, better evaluation and audit approach and better fundamental understanding of underlying residue removal and residue measurement practices and parameters.