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Oct
14

Validation, Verification and Transfer of Analytical Methods

 
 Seminar/trade show (noCPF)

When:

  14 Oct through 15 Oct 2021

Where:

  Online Event | United States

Website URL:

  https://www.complianceonline.com/lab-analytical-compendial-method-ich-q2-glp-part11-annex11-qbd-seminar-training-80291SEM-prdsm?channel=Brownwalker

Sponsoring organization:

  Compliance Online

Categories:

  Medicine & Health - Medical-Speciality

Keywords:

Event description:

Analytical methods used for GxP purposes should be validated to ensure the reliability, consistency and accuracy of analytical data. Compendial methods should be verified to demonstrate the suitability of laboratories to successfully run the method and when methods are transferred between laboratories successful transfer should be demonstrated through testing or a transfer waiver, if justified. If a laboratory uses an alternative method instead of a compendial method, equivalence or superiority of the alternative method should be demonstrated. Recent guidance on method validation and transfer has been produced by FDA and EMA, and USP has guidance chapters on method validation, verification and transfer, equivalence testing and statistical evaluation. Articles in US Pharmacopeial Forum have introduced the concepts of measurement uncertainty and lifecycle management for analytical procedures. Lifecycle management has also been the subject of recent FDA and ICH publications. This... Read more

Posting date:

29 September 2021  |  119 views

Placement:

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