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

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

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.
• What are the factors which impact method performance under actual condition of use?
• How compliance to USP <1226> and investment risk.

Who Will Benefit:

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

• QC personnel
• QC Supervisors and Management
• QA personnel
• QA Management
• Documentation management specialists
• Regulatory affairs personnel
• R&D Lab personnel
• R&D Lab Supervisors

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.