Submission Documentation for Sterilization Process Validation - A Comprehensive View of Content for an Approvable CMC Section 2012
23 Feb 2012
Webinar
Key Topics
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
Past Events
Submission Documentation for Sterilization Process Validation - A Comprehensive View of Content for an Approvable CMC Section 2012 - 23 Feb 2012, Webinar (22217)
Submission Documentation for Sterilization Process Validation - A Comprehensive View of Content for an Approvable CMC Section 2026
Important
Please, check "Submission Documentation for Sterilization Process Validation - A Comprehensive View of Content for an Approvable CMC Section" official website for possible changes, before making any traveling arrangements
