Date: 18 MAY 2017 08:30-17:00
Location: ALK Abelló, Bøge Allé 1, 2970 Hørsholm, Denmark
Continuous manufacturing, continuous process verification and ongoing process verifications are part of the new pharma reality. They are part of the EU GMP Annex 15 regulations for Qualification and Validation and part of the FDA Process Validation Guidance. They are becoming a reality. Some of the most advanced pharmaceutical companies have implemented these new techniques. They will present their practical experiences at this conference, which provides both best practice sharing and a view into the pharma factories of the future, both from the industry and the regulatory perspective.
Keynote speaker at this conference will be Charles Cooney, PhD, Professor of Chemical and Biochemical Engineering, Massachusetts Institute of technology, Boston, US Emeritus in the Department of Chemical Engineering and was the founding Faculty Director of the Deshpande Center for Technological Inovation. He serves as a consultant to a number of biotech and pharmaceutical companies, sits on the Board of Directors of Mitra Biotech, GreenLight Bioscience, Axcella Health, Boyd Technologies, Levitronix Technologies, LayerBio and Innovent Biologics and he chaired the FDA Advisory Committee for Pharmaceutical Science from 2004-2006.
|08.00||Start registration, coffee, visit table top exhibition|
Gert Mølgaard, Moelgaard Consulting
|09.05||To be continuous or Not to be continuous – that is the question!
Charles Cooney, Professor, Massachusetts Institute of technology, Boston, US
|10.00||Requirements of Annex 15, CPV and general GMP updates
Inger Jönebring, Owner and Senior GMP Consultant at medIQ Consulting AB
|10.45||Coffee break & visit table top exhibition|
|11.00||Quality Aspects in Continuous Manufacturing
Dr. Eric J.M. Meier, Head QA Continuous Manufacturing, Novartis Pharma
|11.45||From Batch to Continuous - in theory and in practice.
Andreas Blomberg and Pirjo Tajarobi, Pharmaceutical Tech. & Dev., AstraZeneca Gothenburg
|12.30||Lunch & visit table top exhibition|
|13.30||Continuous Manufacturing from a Regulatory Standpoint
Øyvind Holte, Researcher, Lekemiddelverket, Norway
|14.15||End-to-End Integrated Continuous Manufacture of Monoclonal Antibodies.
Massimo Morbedelli, PhD, Professor, ETH, Switzerland
|15.00||Coffee & visit table top exhibition|
|15.15||Continuous Manufacturing and CPV: Practical experiences from implementation
Speaker TBD, H. Lundbeck
|16.00||Continuously Process Verfication at ALK – Practical Experiences
Linda Pihl and Marianne Havregaard, Senior Chemist, Production Support, ALK
|16.45||Discussion and adjourn|
Vendor table top exhibition during the whole conference.
Download the conference program ( 2 MB).