Validation of NMR: No Need to PANIC - February 13, 2015, LaJolla, U.S.A.

Validation of NMR: No Need to PANIC - Workshop held February 13, 2015, La Jolla, CA, U.S.A.

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Kimberly L. Colson1, Torsten Schoenberger2, and Yulia Monakhova3

1Bruker BioSpin, Billerica, MA 01821, USA; 2Forensic Science Institute of the Federal Criminal Police Office (BKA), Germany; 3Spectral Service, Strasse 33, Cologne, Germany

The Practical Applications of NMR in Industry Conference (PANIC) was founded to address the growing need for discussions of latest NMR developments for practical applications to real problems faced in industry and research institutions (www.panicnmr.com).  During the 2015 conference a workshop was held focused on NMR instrument and method validation.  This poster reviews the workshop goals and plans forward that are of interest to the natural product herbal supplement community.  The resource information resulting from this workshop will ultimately be available at http://www.nmrvalidation.org/.

“Validation of NMR: No Need to PANIC”

“NMR has seen a significant surge in the use for the GxP environment or for accredited laboratories as an analytical tool for many functions that have traditionally utilized other analytical tools, such as HPLC and IR spectroscopy.  However, there is often much consternation concerning the validation of the instruments themselves and the NMR related analytical methodology…..The workshop was facilitated from a panel of experts ranging from representatives in industry, regulatory, academics and NMR manufacturers.  This allowed many aspects of issues to be discussed with the relevant experts to add their perspective.  We look forward to this on-going collaborative experience and to ensure progression of NMR into this regulated environment with greater ease.”


Introduction & Overview of Goal

 8:30am ‐8:50 Kim Colson (Bruker) “We are all in this together”

Regulating Agency Comments & Expectations

8:50 – 9:10 Torsten Schoenberger (BKA) “Regulations, Standards & Guidelines – Let’s try to get an overview!”
09:10–09:30 Dan Bearden (NIST) “The New ASTM Standard for NMR Instruments”
09:30–09:50 Freyja Lynn (FDA) “NMR Assay Validation in Biopharmaceutical Analysis”
09:50–10:10 Kristie Adams (USP) "Validation of NMR Spectroscopic Methods: A USP Perspective"
 10:10–10:30 Break

Basic Terminology & Definitions

10:30–11:20 Torsten Schoenberger (BKA) “An approach to find common language: "Basic Terms in EUROLAB “Guide to NMR Method Development and Validation” and others.”

Validation of NMR Instruments and Methods: Targeted Approaches

11:20–11:50 Catherine Quinn (Baxter) “Experimental Considerations for Validating NMR Quantitation Methods”
11:50–12:20 Dan Sorensen (McMaster Univ) "From R&D to GMP ‐ Quality management and learning experiences

12:20–1:30 Lunch

01:30–02:00 Bernd Diehl (Spectral Services) "Principles of NMR Spectrometry"
02:00–02:30 Ewoud van Velzen (Unilever) “Analytical quality assurance in quantitative NMR”

02:30–02:50 Break

Non‐Targeted Approaches

 2:50 – 3:25 Dan Bearden (NIST) “Don't Panic, It's Just Chemometrics”
3:25 – 4:00 Yulia Monakhova (Spectral Services) “Validation of multivariate NMR methods: challenges and preliminary concept development”

Special Points & Closing Discussion

04:00–05:00 Kim Colson (Bruker) and Torsten Schoenberger (BKA)

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