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
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