Pharmaceuticals 2011 - Submission Documentation for Sterilization Process Validation

Why Should You Attend:
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.

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