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HUM-MOLGEN
-> Events
-> Meetings and Conferences |
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May 03, 2012 |
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ComplianceOnline, Online Webinar
2012-05-31
Why Should You Attend:- The Stability Program is a key component of Product Development. The time scale for a stability studies is relative long, ranging from 2-3 years and is very often on the Critical Path of the Product Development Project. Errors found in the study design, can result in major delays in the project filing. A well designed Stability protocol can result in significant savings during Product Development and after product approval.
This 3-hr comprehensive training course outlines the issues and guidelines surrounding FDA, ICH and increasing important Global regulatory requirements. The course will address all the steps in a stability program starting from designing an effective stability study to choosing the right Stability methods and specifications for GMP compliance. Areas Covered in the Seminar:- - Overview of ICH and WHO requirements for Stability Programs.
- What are the Stability study requirements for Phase I, Phase II, Phase III clinical studies.
- What are the required Post Approval Stability studies.
- How to set up, conduct and complete a stability study.
- How to choose the right Stability methods and specifications.
- What are the common pit falls. 483s related to Stability programs.
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Organized by:
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ComplianceOnline |
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Invited Speakers:
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Dr. Subbarao, holds a Ph.D. in Bio-organic Chemistry. Her hands-on industrial experience covers stability and laboratory cGMP systems for both biologics and conventional drugs. She has extensive experience in evaluation of analytical methods and method validation for products ranging from conventional drugs, well characterized proteins, vaccines, cell therapy and gene therapy products, ranging from pre-clinical phase to commercial phases. She has extensive expertise in setup of cGMP/GLP complaint Quality Systems for laboratory and stability programs as well as upgrade of existing Quality Systems for products during development and in commercial phase.
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Deadline for Abstracts:
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2012-05-31
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Registration:
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For Registration:-
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E-mail:
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referral@complianceonline.com
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