Submission Documentation for Sterilization Process Validation - A Comprehensive View of Content for an Approvable CMC Section 2012
February 23, 2012(Ended)
Online Webinar
The Submission Documentation for Sterilization Process Validation - A Comprehensive View of Content for an Approvable CMC Section is a webinar that covers topics such as:
- Recent changes in regulatory guidance
- Global regulatory guidance and other relevant sources for sterility assurance
- Differences in content for terminal sterilization versus aseptic processes
- Sterility assurance content for marketing applications
- Use of parametric release in lieu of sterility testing at release
- Expectations for requalification of sterile processes
- Validation documentation for microbial quality test methods
- Use of container closure integrity in lieu of sterility testing on stability
- Potential pitfalls due to insufficient sterility assurance documentation
Prices *
249-999 US Dollar
Exhibition
No exhibition
Organization
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Concurrent events
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Please, check the conference website for possible changes, before you make any traveling
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* Prices are for evaluation only.
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