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Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)

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Website https://www.complianceonline.com/lab-analytical-compendial-method-ich-q2-glp-part11-annex11-qbd-semi | Edit Freely

Category

Deadline: March 13, 2020 | Date: March 23, 2020-March 24, 2020

Venue/Country: San Francisco, CA, U.S.A

Updated: 2020-01-02 23:53:35 (GMT+9)

Call For Papers - CFP

Analytical methods 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.

This 2-day workshop will help attendees to understand regulatory requirements for method validation, verification and transfer. It will also suggest ways to de-risk the method validation process through prior evaluation of method performance and the use of effective protocols. The course includes workshops to help attendees plan method validation and to select appropriate acceptance criteria, as well as checklists for validation protocol and analytical method contents.


Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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