Analytical Procedure Lifecycle Management / Revisions to ICH Q2 & the proposed Q14 This conference is part of PharmaLab 2019
Programme
Programme - 12 November 2019
Congress Keynote 12.11.2019: New ICH Q14 and ICH Q2 Revision – an industry view (Key Note Presentation at the Plenum)
New ICH Q14 and ICH Q2 Revision – an industry view (Keynote Presentation at the Plenum)
Dr Joachim Ermer, Sanofi-Aventis Deutschland Head of QC Lifecycle Management Frankfurt Chemistry
Introduction to ECA AQCG
Dr Christopher Burgess, Chairman of the ECA AQCG Board
Overview of USP, ICH revisions & APLM Guideline; Prerequisites and approaches
Dr Christopher Burgess, Chairman of the ECA AQCG Board
Introduction to ATP & TMU
Phil Borman, GSK
Data integrity over the Analytical Procedure Lifecycle
Bob McDowall, R.D. McDowall Limited
Stage 1: Procedure Design & Development
Margarita Sabater, Dako Denmark, an Agilent Technologies Company
Stage 1 in Practice
Phil Borman, GSK
Analytical Control Strategy Workshop
Dr Gerd Jilge, Boehringer Ingelheim
Margarita Sabater, Dako Denmark, an Agilent Technologies Company
Programme - 13 November 2019
Congress Keynote 13.11.2019: Laboratory Services - from Outsourcing to a strategic partnership (Key Note Presentation at the Plenum)
Laboratory Services - from Outsourcing to a strategic partnership (Key Note Presentation at the Plenum)
Dr Jürgen Balles, Dr Thomas Meindl and Ingo Grimm, Labor LS
Stage 2: Procedure Performance Qualification: Problems and issues?
Dr Gerd Jilge, Boehringer Ingelheim
Approaches to the transfer of Analytical Procedures
Ulla Bondegaard, Novo Nordisk
Stage 3: Procedure Performance Verification
Silviya Dimitrova, Teva
Experiences in the ongoing verification of Analytical Procedures
Ulla Bondegaard, Novo Nordisk
"What happens with Legacy Products?" Workshop
Silviya Dimitrova, Teva
Dr Christopher Burgess, Burgess Analytical Consultancy
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