Live Online Conference: Challenges in Bioanalytical and Analytical Laboratories - Day 2 - Analytics - From Life Cycle Management to Real Time - Part of PharmaLab 2020

Programme

09.00 - 09.45 h
Key Note: RTRT: A Reality Check in the Small and Large Molecule World
Dr Lorenz Liesum, F. Hoffmann-La Roche

 

09.45 – 10.30 h - Analytical Procedure Lifecycle Management, practical Implementation of Routine for Process Verification
Ulla Bondegaard, Novo Nordisk

 

09.45 – 10.30 h - Analytical Procedure Lifecycle Management, practical Implementation of Routine for Process Verification
Ulla Bondegaard, Novo Nordisk

 

10.30 – 11.00 h - Life Cycle Management of Analytical Procedures - Regulatory Perspective
Ketan Agravat, rK3 Solutions

 

11.00 – 11.15 h Break

 

11.15 – 11.45 h - Key Performance Indicators in Pharmaceutical Quality Control Laboratories - Tools to measure and monitor Optimizations
Dr Karl-Heinz Bauer, Boehringer Ingelheim

 

11.45– 12.15 h - The value of Pharmacopeial RS: A Story about Uncertainties, associated Guard Bands and Secondary RS
Dr Christian Zeine, USP

 

12.15 – 12.45 h - Questions and Answers

 

12.45 – 13.45 h Break

 

13.45 – 14.15 h - Small Molecule Drugs & Analytics - SWOT Analysis on the OOS/OOT/OOE established System
Laura-Felicia Cristescu, STADA Hemofarm SRL (STADA Group )

 

14.15 – 14.45 h - Validation of Analytical Methods 
Judith Kernbichler, Takeda

 

14.45 – 15.15 h - OOS, OOT, OOE – Update from practical Experiences
Dr Jörg Neumann, Jörg Neumann Beratung

 

15.15 – 15.30 h Break

 

15.30 – 15.45 h - Strategic Design of HCP Analysis during Clinical Phases
Kai Kottwitz, Rentschler

 

15.45 – 16.15 h - Real-time Measurements of Starting Materials used in Tablet Production
Roland Koch, Gasporox

 

16.15 – 17.00 h - Questions and Answers