Pharmaceuticals 2011 - Why and How - Verification of Compendial Methods - USP

Why Should You Attend:
Recent warning letter continue to emphasize the fact that the FDA has stepped up the stringency and frequency of inspections. Non-compliance to USP <1226> continues to feature prominently in the 483s issued.

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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