Workshop 2019

Agenda

March 7, 2019

 

 

08:15       Coffee is served

08:30       Welcome – Opening Statements Torsten Schönberger (BKA) & Michael Maiwald (BAM)

08:50       Presentation: “Quality by Design (QbD) principles applied to NMR methods” Ian Clegg  (Bruker Biospin Inc.)

09:10       Presentation: “Validation of Software” Carlos Amezcua (Baxter International Inc.)

09:30       Presentation: “Good Weighing Practice (GWP) for accurate qNMR sample preparation” Tucker Rubino (Mettler-Toledo GmbH)

09:50       Break

10:10       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       Presentation: “ValidNMR Website and Wiki” Kristie Adams (Steelyard Analytics)

12:00       Lunch

13:00       Presentation: “Tackling ‘dark’ uncertainty in SI traceable qNMR analysis of peptides and glycans” Cailean Clarkson (LGC)

13:20       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)

14:50       Open Forum – Q&A, Discussions ValidNMR committee members

15:15       The Workshop Adjourns – Closing Statements Torsten Schönberger (BKA) & Michael Maiwald (BAM)

15:30      ValidNMR Business Meeting ValidNMR committee members (open to observers and interested parties)

17:30      The ValidNMR Business Meeting Adjourns

 

 

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