Having a plan for gathering and compiling appropriate sterility assurance
documentation to be included in a global marketing application is essential for
injectable drug products.
In this session we will provide an overview of current
regulatory guidance...
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Having a plan for gathering and compiling appropriate sterility assurance
documentation to be included in a global marketing application is essential for
injectable drug products.
In this session we will provide an overview of current
regulatory guidance and compendial requirements associated with sterilization
validation and control of microbial quality.
While guidance on overall content is readily available, a lack of understanding of
specifically what information is needed and how to present it could result in
regulatory questions, delay of approval, and costly repeats.
This webinar will
review what information is needed, what level of detail is included, and how to
present the documentation in CTD format.
Attendance cost: 199$
Event organizer: ComplianceOnline
More Information about the Webinar: Submission Documentation for Sterilization
Process Validation at http://itevent.
net/submission-documentation-forsterilization-process-validation
About ITEvent:
At ITEVENT.
NET we colle
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