“How to implement PAT and QbD in your manufacturing” 

INVITATION: The QbD Innovation Consortium would like to invite you to the Seminar “How to implement PAT and QbD in your manufacturing” The Innovation Consortium “QbD – Quality by Design in the Food and Pharmaceutical Industries” (www.qbd.dk) is a collaboration between eight partners working together for each to improve their competitiveness through the use of sensors and statistical tools to develop new approaches to monitor the production processes. The QbD project is funded by the partners and in part by the Forsknings‐ og Innovationsstyrelsen. The arrangement is made in collaboration with the inSPIRe project (www.inspirefood.dk). Audience: Manufactures and researchers with an interest in process improvement, PAT and QbD. Speakers: Experts involved in practical problem solving representing academia, technological institutes, food‐ and pharma‐industries will present a wide range of cases. Venue: DELTA Danish Electronics, Light & Acoustics, Venlighedsvej 4, 2970 Hørsholm Date/time: Monday October 29th, 2012, 9:00‐16:00h Participation fee: 900 DKK, including handouts Language: English Process Analytical Technology (PAT) is a collection of techniques used to measure and model key information in production processes in food, biotech, pharma and other industries. An important aspect is Process Analytical Chemistry (PAC), the in‐process (on‐line or real‐time) measurement of relevant concentrations and other properties. A second part of PAT is multivariate data modeling, known as Process Chemometrics (PC). In PC the behavior of the complex manufacturing systems are not only seen by mechanistic or first principle models but also as latent or principal phenomena. A third component in PAT is finding the best safe and profitable production settings, the so‐called design space or more general Quality‐by‐Design. In short: PAT = PAC + PC + QbD. The motivation for PAT/QbD is continuous improvement. All processes in manufacturing work to some extent, but improvements with a potentially substantial economic and environmental impact can be achieved by making a processes work (a little or a lot) better! Most present‐day processes are still run by a combination of recipe operation available from engineering knowledge and equipment design such as mass and energy balances, inferential control easily measured such at temperature, flows and pressures, and end‐product laboratory analysis. PAT/QbD tries to improve on this situation by measuring and using key, to‐the‐point, product and process variables with high frequency (e.g. chemical composition in real‐time) in estimates of the process state or adjustment of settings for the current and subsequent process steps. You can register for this event by mail or phone to Lisa Engedal Nielsen at [email protected] or 7219 4314 before October 19th 2012. The partners of the QbD project are: H. Lundbeck A/S, Novo Nordisk A/S, Arla Foods amba, CMC Biologics A/S, Carometec A/S, Sartorius Stedim Biotech GmbH, University of Copenhagen – Faculty of Science, DELTA. “How to implement PAT and QbD in your manufacturing” When: Monday October 29th, 2012 Where: DELTA Danish Electronics, Light & Acoustics, Venlighedsvej 4, 2970 Hørsholm Fee: 900 DKK, including lunch and print‐out material Language: English 09:00‐09:15h Søren B. Engelsen, KU‐Food Welcome 09:15‐09:45h Anders Larsen, Q‐Interline A/S PAT – keep it simple! 09:45‐10:15h Jens Michael Carsten, Videometer A/S Imaging spectroscopy for process understanding and control 10:15‐10:45h Coffee break 10:45‐11:00h Jesper Bryde‐Jacobsen, NNE Pharmaplan The BioPro initiative 11:00‐11:30h Klavs Martin Sørensen, KU‐Food Real‐time quality monitoring in the slaughter industry 11:30‐12:00h Casper Leunhagen, Novo Nordisk A/S Useful tools for assessment of chromatographic data – a pharmaceutical case study 12:00‐13:00h Lunch Networking
13:00‐13:15h Jens Gram, CMC Biologics Title to be announced 13:15‐13:45h Line Lundsberg, PAT consultant Title to be announced 13:45‐14:15h Christian B. Zachariassen, Novozymes A/S QbD for Biotechnology – how does PAT fit in? 14:15‐14:45h Coffee break 14:45‐15:10h Michael Mealy, H. Lundbeck A/S Our Journey from Process Understanding to QbD Mentality 15:10‐15:45h Jesper Pram, H. Lundbeck A/S PAT and QbD Implementation in Industrial API Manufacturing 15:45‐16:00h Frans v.d. Berg, KU‐Food Summary of the day and Discussion