This course provides the attendee with an understanding of the USP Chapter <1226>. FDA 483s on the subject of Method Verification will be discussed.
Why Should You Attend:
The new <1226>, 'Verification of Compendial methods' was published in second supplement to USP 30 - NF 25 (2007) and is now official. Compliance to USP <1226> is one of the FDA requirements for analytical methods used during lot release and stability testing. Poor compliance to these requirements has lead to recent 483s, warning letters and more severe regulatory actions. A compendial analytical method is considered to be validated. However, the FDA requires that "The suitability of all testing methods used shall be verified under actual conditions of use".
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 The factors under actual conditions of use which impact method performance and make method verification necessary will be addressed.
Areas Covered in the Seminar :
- What are the current FDA expectations related to method verification.
- FDA 483s related to method verification.
- Requirements of USP <1226>, 'Verification of Compendial Methods'
- USP <1226> requirements for different analytical 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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