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Why and How - Verification of Compendial Methods - USP <1226>

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This USP <1226> webinar training will discuss the requirements of USP <1226>, what are FDA expectations related to method verification.

Speaker
Instructor: Nanda Subbarao
Product ID: 701752
Training Level: Intermediate to Advanced

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:

Who Will Benefit:

This course is intended to provide training on how to evaluate compendial methods in order to comply with USP <1226>

Instructor Profile:

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.

She is an ASQ Certified Quality Auditor with 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. She is currently a Senior Consultant with the Biologics Consulting Group specializing in Analytical, Stability, CMC and GLP/GMP Quality Systems. She serves on the AAPS Stability Focus Group Steering Committee. She also serves on the AAPS National Biotechnology Conference Programming Committee for 2009 to 2011 as the Regulatory Sciences lead.

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Refund Policy
"Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance.
ComplianceOnline would process/provide refund only if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs."
For substitution, please email editor@complianceonline.com or call +1-650-620-3937.

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