This webinar will provide an in-depth discussion of USP <1226>, 'Verification of Compendial Methods' requirements. We will discuss FDA 483s on the subject of Method Verification to understand current FDA expectations.
Why Should You Attend:
This webinar will provide an in-depth discussion of USP <1226>, 'Verification of Compendial Methods' requirements. 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 for verification of compendial methods.
Areas Covered in the Webinar:
- FDA 483s related to method verification.
- Requirements of USP <1226>, 'Verification of Compendial Methods'
- What are the current FDA expectations related to method verification.
- What are the factors which impact method performance under actual condition of use?
Nanda K. Subbarao,
Group Leader and Senior Consultant ,
Biologics Consulting Group
Dr. Subbarao is currently a Senior Consultant with the Biologics Consulting Group specializing in Analytical, Stability, CMC and GLP/GMP Quality Systems. She has assisted pharma and biotech organizations in evaluation of analytical methods and method validation for a wide range of products ranging from conventional drugs to well characterized proteins and vaccines, from pre-clinical phase to commercial phases. She has been involved several times over her career in projects to setup or upgrade cGMP/GLP complaint Quality Systems for laboratory and stability programs for products during development and in commercial phase. She participates in the AAPS Stability Focus Group Steering Committee.