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Validation Workshop

Thursday, March 7, 2019

Workshop Agenda

8:15 a.m.  Coffee is served

8:30 a.m.  Welcome – Opening Statements

Torsten Schönberger (BKA) & Michael Maiwald (BAM)

8:50 a.m.  Ian Clegg, Bruker Biospin Inc. 


“Quality by Design (QbD) principles applied to NMR methods”

9:10 a.m. Carlos Amezcua, Baxter International Inc.

“Validation of Software”

9:30 a.m. Tucker Rubino, Mettler-Toledo GmbH


“Good Weighing Practice (GWP) for accurate qNMR sample preparation”

9:50 a.m. Break

10:10 a.m.  Workshop Session #1: Design of Analytical Procedures

 (A) Establish an Analytical Target Profile (ATP)

Session Leader: José G. Napolitano, AbbVie

 (B) Identify the Critical Quality Attributes of qNMR

Session Leader: Dan Sorensen, Eurofins Alphora

 (C) Plan the Analytical Instrument Qualification

Session Leader: Christoph Freudenberger, Bruker Biospin Inc.

11:40 a.m.  Kristie Adams, Steelyard Analytics

“ValidNMR Website and Wiki”

12:00 p.m.  Lunch

1:00 p.m.  Cailean Clarkson, LGC

"Tackling ‘dark’ uncertainty in SI traceable qNMR analysis of peptides and glycans” 

1:20 p.m. Workshop Session #2: Verification of Analytical Procedures

(D) Plan the Analytical Control Strategy and Verification

Session Leader: Torsten Schönberger, BKA

(E) Experimental Factors to Consider for Generation of a qNMR Method Validation Protocol 

Session Leader: Joe Ray, Baxter International Inc.

(F) Use of Statistical Tools for Evaluation of Measurement Uncertainty

Session Leader: Michael Maiwald, BAM

2:50 p.m.  Open Forum – Q&A, Discussions ValidNMR committee members

3:15 p.m. The Workshop Adjourns – Closing Statements


Torsten Schönberger (BKA) & Michael Maiwald (BAM)

3:30 p.m.  ValidNMR Business Meeting


ValidNMR committee members (open to observers and interested parties)

5:30 p.m.  ValidNMR Business Meeting Adjourns