Method Validation

At IVT's Laboratory Compliance Week, USP Expert Committee member Jane Weitzal explained the basics of the analytical target profile (ATP) concept and the analytical procedure lifecycle. ATP's definition, relation to the quality target product profile, and its advantages are analyzed and then explained using an example from USP.


There are some common trends in US Food and Drug Administration citations and observations in the laboratory. While issues in...Download
Compliance in the manufacturing laboratory is a multi-faceted and often elusive goal. Alice Krumenaker, in her presentation...Download
Training in the laboratory cannot be a one-time event. Adapted from Alice Krumenaker's supplementary material at IVT'...Download
Quality-by-design (QbD) is a systematic approach whereby desired traits and performance are built into a process to ensure...Download
During a session on analyzing and identifying impurities at IVT's 11th Annual Method Development and Validation conference, Rafail Usatinsky led the attendees through the process of identifying and analyzing chiral impurities. A common problem was presented, and Usatinksy discussed the subsequent development plan, reaction conditions, reaction chromatograms, chiral chromatograms, and method...
In this pre-recorded webinar, Siegfried Schmitt describes the current understanding and expectations for implementation of quality-by-design (QbD). Approaches, benefits, and potential pitfalls, especially for regulatory applications, are be presented. After viewing the webinar, participants will be able to: 
In the third case-study from his presentation at IVT's 9th Annual Method Validation and Development conference, Rafail Usatinsky explained the methodology for identifying and evaluating contamination impurities. A problem wherein small pieces of contaminant were found in an unstable intermediate.
In his presentation from IVT's 9th Annual Method Validation and Development conference, Rafail Usatinsky explains how to isolate and identify impurities in the drug development timeline. Ustatinksy discusses what needs to be determined in the initial planning and compares the concepts of isolation versus synthesis. Usatinsky also illustrated the proper methodology with an impurity isolation case...
The staff of IVT were onsite at the 2015 EU Validation Week held in the center city of Amsterdam's Crowne Plaza Hotel. Check out some photos from the conference's opening speeches.
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