Continued and On-Going Process Verification

9th and 10th April 2018 - Conference
11th April 2018 - Workshop
NH Collection Berlin Friedrichstrasse

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Intro / Registration  / Agenda / Venue

GMP Expectations After the Implementation of Annex 15
Klaus Eichmueller, Wolnzach c/o Regional Council Darmstadt, GMP Inspectorate, Germany

FDA’s Trending New Validation Strategies
Dr Ajaz S. Hussain, Insight, Advice & Solutions, LLC (Former FDA Deputy Director), USA

Continued Process Verification Stages (Stage 3A and 3B)
Ajay Pazhayattil, Associate Director, TO Process Validation, Apotex Inc., Canada

Change and Risk Management in Continuous Process Validation
Adelheid Schweiger, Senior Consultant Quality & Compliance, and
Sabine Quast, Senior Consultant Quality & Compliance, Arcondis Group, Germany

CPV Challenges with Outsourcing
Dr Kai Juergens, Senior Project Manager External Manufacturing, Bayer Pharma AG, Germany

Quality Metrics and the Link to Process Verification
Robin Payne, Facilitator, BioPhorum, United Kingdom

CPV in Practice – a Quality by Design Point of View
Gabriele Gold, Head of PSTO/QbD, Baxalta AG, Austria

CPV in Practice – a Quality by Design Point of View
Florian Jantscher, Process Science & Technical Operations, Shire, Austria

SPC as Part of Continuous Validation
Per Vase, Managing Partner, Applied Manufacturing Science, NNE, Denmark

ICH Q12: Pharmaceutical Product Lifecycle Management – an Industry Perspective
Dr Joerg Gampfer, Vice President, Quality, Hovione, Portugal

Continued and Ongoing Process Verification – How to get from a Traditional to a New Lifecycle Validation Approach
Timur Güvercinci, Director, Head of QA Chemical Pharmaceutical Development, Merck KGaA, Germany

Continuous and Continued Process Verification – the Future Role of PAT
Dr Lorenz Liesum, Manufacturing, Science & Technology, Global Head Statistics and PAT, Novartis Pharma AG, Switzerland

Process Validation Review During Regulatory Inspections
M. Narendira Kumar, Associate Director & Head Quality Assurance, Dr. Reddy’s Laboratories, India

Risk management and Product Development: From Formulation and Process Design to Validation
Stavros Politis PhD, Director Formulation Development, Genepharm S.A., Greece

Case Study: Implementation of a Risk-based Default Response Plan into an Operational CPV Program
Dr Guillermo Gambero, Process Scientist, Pfizer Biotech Ireland

Tools to support CPV implementation
Wilfrid Percevault, Data Scientist, Sanofi Pasteur – MTECH, France