Analytical Procedure Lifecycle Management - This conference is part of PharmaLab 2018

Analytical Procedure Lifecycle Management - This conference is part of PharmaLab 2018

Düsseldorf/Neuss, Germany

Course No 200032


Costs

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Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Programme

Overview of the new APLM Guideline & the Workshop
Dr Christopher Burgess, Chairman of the ECA AQCG Board

Stage 1: Procedure Design and Development
Margarita Sabater, ECA AQCG Board

Stage 2: Procedure Performance Qualification (PPQ)
Dr Gerd Jilge, ECA AQCG Board

Stage 3: Procedure Performance Verification
Silviya Dimitrova, ECA AQCG Board

APLM Questionnaire
Dr Christopher Burgess, Chairman of the ECA AQCG Board

Workshop Critique of a SWOT Analysis of the APLM
All members of the ECA AQCG Board

ICH Concept Paper for Revision of Q2(R2) & Q14
Dr Christopher Burgess, Chairman of the ECA AQCG Board

Interactive discussion of the ICH implications and Questions

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