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

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.

Topics: Laboratory compliance, Analytical methods, data, procedures, compendial methods, Method validation and transfer, equivalency testing, FDA inspection, SOPs, FDA and EU compliance, documentation, ICH Q2, USP chapters 220, 1200, 1210, 1220, USP, >, GLP, GCP, GMP, FDA Warning Letters, Part 11, Annex 11, LOD, LOQ, HPLC to UHPLC, INDA, ANDA, NDA submissions, QbD, statistical evaluation, Training by, Analytic Lab workshop