Workshop 2018

March 8, 2018

08:00 Coffee is served

Welcome

08:20       Welcome – Opening Statements Kim Colson (Bruker) & Torsten Schoenberger (BKA)

Session 1

08:50       Lightning Talk: “Quality Improvement in qNMR Spectroscopy” Elina Zailer (Spectral Service)

09:00       Presentation: “qNMR Method Validation Following the USP 1210 Chapter, Statistical Tools for Procedure Validation” Carlos Amezcua (Baxter International Inc.)

09:20       Workshop Session #1

                (A) ValidNMR Wiki Kristie Adams (Steelyard Analytics)

                (B) Required Validation Parameters Stefan Garms (Lonza)

10:20       Workshop debriefing (Session leaders)

10:30       Break

Session 2

11:00       Lightning talk: “Meeting the requirements of FDA, ISO, GxP” Bernd Diehl (Spectral Service)

11:10       Presentation: “Validation Strategy using Lifecycle and Quality Risk Management” Dan Sorensen (Eurofins | Alphora Research Inc.)

11:30       Workshop Session #2

                (C) Data Integrity Carlos Amezcua (Baxter International Inc.)

                (D) Protocols / Education Elina Zailer (Spectral Service)

12:30       Workshop debriefing (Session leaders)

12:40       Lunch

Session 3

13:30       Lightning talk: “A new realization of SI for organic chemical measurement: NIST PS1” Michael Nelson (NIST) 

13:40       Presentation: “The Nuts and Bolts of qNMR” Ian Burton (NRC)

14:00       Workshop Session #3

                (E) Uncertainty Analysis Michael Maiwald (BAM)

                (F) Reference Material Kevin Millis (CIL)

15:00       Workshop debriefing (Session leaders)

15:10       Break

15:30       Presentation:  “Novel Proficiency Testing Scheme for ¹H, ³¹P and ¹⁹F quantitative Nuclear Magnetic Resonance (qNMR)” Markus Obkircher (Merck KGaA)

16:00       Open Forum Kim Colson (Bruker) & Torsten Schoenberger (BKA)

17:00       Closing Statements Kim Colson (Bruker) & Torsten Schoenberger (BKA)