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Automation, Robotics and Digitalization in QC Labs
Date
June 24, 2020
Automation, Robotics and Digitalization in QC Labs
Automation, Robotics and Digitalization in Biopharmaceutical QC Labs The goal of this session is to engage laboratory leaders, automation and informatics experts, regulators, and instrument/equipment/software vendors in rich discussions regarding the use of automation, robotics, and digital solutions to advance multiple dimensions of operational excellence in the pharma quality control laboratories.
Technology Solutions & Business Drivers for Moving from Manual to Automated Solutions in the Pharmaceutical QC Lab
Jacqueline Larew, Senior Advisor-Global Quality
Eli Lilly and Company
Mark G. Schweitzer, Global AS&T and Scientific Initiatives
Novartis
QC Today and QC in the Future
Vinny Browning III, Executive Director Commercial Attributes Sciences
Amgen
Case Study: Automation of Stability Data Reporting and Trend Analysis
Janine Kuratli, Manager Data Analytics
CSL Behring
Case Study: Automated Technology Platform for Real-Time PCR-based Adventitious Agent Detection
Sven M. Deutschmann, PhD, Head of Global ASAT
Adventitious Agents
Testing & Alternative Microbiological Methods, Global QC
Sven M. Deutschmann, PhD, Head of Global ASAT
Roche Diagnostics GmbH
CASE STUDY 1: Practical Applications for OOS Investigations/Assessments | Background to case-studies that will be addressed: Issues observed included observations of repeat testing until a better and/or passing result is obtained; maximum number of retests NOT specified in SOP; vary based on variab…
CASE STUDY 4: Aseptic Processing Controls | Imagine the perfect storm. This case study involves a manufacturer of medically necessary sterile drug products and combines numerous failures across various systems…
CASE STUDY 3: Critical Review of Quality and Manufacturing Data | Emer-Pen is part of General-Pharma’s auto-injector portfolio. It is a single-use drug-device combination product, comprising device components with sterile injectable solution cartridge…