The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: March 25, 2021 at 10am to March 26, 2021 at 5pm
Street: Compliance Online, 2479 E. Bayshore Road
City/Town: Palo Alto
Website or Map: https://www.complianceonline.…
Event Type: seminae
Organized By: ComplianceOnline
Latest Activity: Mar 15, 2021
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 2-day seminar 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.