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HUM-MOLGEN
-> Events
-> Meetings and Conferences |
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May 03, 2012 |
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ComplianceOnline, Online Webinar
2012-05-16
Why Should You Attend:- Analytics continues to be a challenging area for GMP compliance and the number of warning letters that are focused on this area continue to increase . Non-compliance to USP <1226> feature prominently in the 483s issued. Laboratory staff continues to have questions about the difference between method Validation and Verification and the conditions under which these two different concepts need to be applied. This webinar will provide an in-depth discussion of USP <1226>, 'Verification of Compendial Methods' requirements. FDA 483s on the subject of Method Verification will be discussed to understand current FDA expectations. Conditions under which Methods can be classified as 'basic' and not require verification will be discussed. The factors under actual conditions of use which impact method performance and make method verification necessary will be addressed. FDA 483s on the subject of Method Verification will be discussed to understand current FDA expectations on which compendial methods needs to be verified. Areas Covered in the Seminar:- - FDA 483s related to method verification.
- Requirements of USP <1226>, 'Verification of Compendial Methods'.
- What are the current FDA expectations related to method verification.
- FDA 483s related to method verification.
- Requirements of USP <1226>, 'Verification of Compendial Methods'.
- What are the factors which impact method performance under actual condition of use?
- How compliance to USP <1226> and investment risk.
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Organized by:
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ComplianceOnline |
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Invited Speakers:
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Dr. Subbarao, received her Ph.D. in Bio-organic Chemistry from the Indian Institute of Technology, Bombay, India. 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.
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Deadline for Abstracts:
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2012-05-16
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Registration:
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For Registration:- http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701752?channel=hummolgen
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