Validation Workshop

Thursday, October 22

Workshop Agenda

9:00 a.m.  Coffee is served

 

9:30 a.m.  Welcome – Opening Statements

Torsten Schönberger (BKA) & Dan Sorensen (Eurofins CDMO)

10:00 a.m.  Presentation: Future Outlook for Validation of NMR Procedures in Pharma

 

Dan Sorensen (Eurofins CDMO)

10:30 a.m.  Presentation: ISO 17025 Requirements

Torsten Schönberger (BKA)

11:00 a.m.  Presentation: Proficiency Testing

John Edwards (Process NMR Associates, LLC)

11:30 a.m.  Presentation: NMR Validation as Per ICH Guidelines

Cathy D. Moore (Element Materials Technology)

12:00 p.m.  Lunch

1:00 p.m.  Presentation: BAM Quality Toolbox Framework

Klas Meyer (BAM)

1:30 p.m.  Panel Discussion: Process Automation -- Human or Inhuman?

Facilitator: Kristie M. Adams (Steelyard Analytics, Inc.)

2:30 p.m.  Open Forum - Q&A, Technical Discussions

Facilitators: ValidNMR Committee Members

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

Torsten Schönberger (BKA) & Dan Sorensen (Eurofins CDMO)

 

3:30 p.m.  Getting Involved with ValidNMR

ValidNMR Committee Members and Interested Parties

5:30 p.m.  The ValidNMR Committee Adjourns

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