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 / Speakers / Venue / Presentations

Agenda

Monday, 9th April 2018

8.00
Registration and Coffee

8.30
Chairman’s Opening Remarks
Dr Kai Juergens, Senior Manager External Manufacturing, Bayer Pharma AG, Germany

8.40
GMP Expectations After the Implementation of Annex 15
Klaus Eichmueller, Wolnzach c/o Regional Council Darmstadt, GMP Inspectorate, Germany

9.30
FDA’s Trending New Validation Strategies and Performance Standards
Dr Ajaz S. Hussain, Insight, Advice & Solutions, LLC (Former FDA Deputy Director), USA

10.20
Networking and Coffee

10.50
Continued Process Verification Stages (Stage 3A and 3B)
Ajay Pazhayattil, Associate Director, TO Process Validation, Apotex Inc., Canada

11.40
Pharmaceutical Product Lifecycle Management – an Industry Perspective
Dr Joerg Gampfer, Vice President, Quality, Hovione, Portugal

12.30
Networking and Lunch

13.50
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

14.40
Integrating Internal and External CPV – a Practical Approach
Florian Jantscher, QbD Systems, Process Development & Technical Services, Shire, Austria

15.30
Networking and Coffee

16.00
Outsourcing and Continued Process Verification: Risks and Benefits
Dr Kai Juergens, Senior Manager External Manufacturing, Bayer Pharma AG, Germany

16.50
SPC as Part of Continuous Validation
Dr Per Vase, Managing Partner, Applied Manufacturing Science, NNE, Denmark

17.40
Closing Remarks

18.30
Evening Reception

Tuesday, 10th April 2018

8.50
Chairman’s Opening Remarks
Dr Kai Juergens, Senior Manager External Manufacturing, Bayer Pharma AG, Germany

9.00
The Interfaces Between the Different Stages of Continuous Process Validation
Jarle André Haugan PhD, Primary Production Oslo Plant, GE Healthcare Life Sciences, Norway

9.50
Risk Management and Product Development: From Formulation and Process Design to Validation
Stavros Politis PhD, Director Formulation Development, Genepharm S.A., Greece

10.40
Networking and Coffee

11.10
Understanding the Variation during Development and Routing Manufacturing
M. Narendira Kumar, Associate Director & Head Quality Assurance, Dr. Reddy’s Laboratories, India

12.00
The Potential Linkage between the FDA’s Quality Metrics Initiative and CPV
Robin Payne, Facilitator, BioPhorum, United Kingdom

12.50
Networking and Lunch

14.10
Tools to Support CPV implementation
Wilfrid Percevault, Data Scientist, Sanofi Pasteur – MTECH, France

15.00
Case Study: Implementation of a Risk-Based Default Response Plan into an Operational CPV Program
Dr Guillermo Gambero, Process Scientist, Pfizer Biotech Ireland

15.50
Networking and Coffee

16.20
Continuous and Continued Process Verification
Dr Lorenz Liesum, Manufacturing, Science & Technology, Global Head Statistics and PAT, Novartis Pharma AG, Switzerland

17.10
Closing Remarks

17.15
End of Conference

 

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