World Conference Calendar

34594 Conferences

A Comprehensive View of Content for an Approvable CMC Section

Added by Referral on 2011-03-03

Conference Dates:

Start Date Start Date: 2011-03-29

Conference Contact Info:

Contact Person Contact Person: Referral
Email Email:
Address Address: 2600 E. Bayshore Road, Online Event,Palo Alto, CA, 94303, United States
Phone Tel: 650-620-3915
Phone Fax: 650-963-2556

Conference Description:

Attend this webinar to learn specifically what information is required in sterility assurance documentation and how to present it in CTD format. You will understand differences in content for terminal sterilization versus aseptic processes.

Areas Covered in the Seminar:

Global regulatory guidance and other relevant sources for sterility assurance.
Recent changes in regulatory guidance.
Sterility assurance content for marketing applications.
Differences in content for terminal sterilization versus aseptic processes.
Expectations for requalification of sterile processes.
Use of parametric release in lieu of sterility testing at release.
Use of container closure integrity in lieu of sterility testing on stability.
Validation documentation for microbial quality test methods.
Potential pitfalls due to insufficient sterility assurance documentation.

NOTE: Use This Promocode ( 117660 ) To Get 10% Discount.
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