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Coming meeting ●
Earlier meetings (including slides) ●
Steering committee
Mission:
To provide a professional technical group to support all levels of
competence of Process Analytical Technology within the Scandinavian
region. Members are welcomed from industry (pharmaceutical, food,
biotechnology, medical devices, etc.), academia, regulators & suppliers
industries.
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Provide a coordinated communication route from its
members to and from all external parties (e.g. regulatory bodies,
advisory boards, workshops, courses and speakers)
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Provide opportunity for discussions and reviews of
technical guidelines
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Efficient time management for its membership, by
specifically providing a platform for: workshops, courses, symposiums,
and speakers for members within Scandinavia
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Exchange of knowledge with healthcare and
non-healthcare professionals.
Although the activities are financed
by ISPE, the meetings are free and open to anyone with a sincere
interest in sharing knowledge and discussing problems.
Meetings:
The Nordic PAT CoP has been active for several years but
changed focus by 2007. The focus is now on providing practical
tools for learning and implementing PAT. This is pursued in meetings where the
content is very much driven by user input.
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Coming meeting(s):
PROGRAM Dear Nordic PAT CoP members,
Next meeting will be held on the 21st of October 2009,
10:00-16:00h
at Umetrics AB
Stortorget 21, 4
211 34 Malmö
Sweden
The office of Umetrics is situated in central Malmö – 5 minutes walk from the
central station. Trains run from København H to Malmö C every 20 minutes and
takes 35 minutes.
The meeting will focus at Risk Management. We are currently working at the final
agenda, and you’ll receive it before the meeting.
However don’t hesitate to sign up for the meeting, because this will be an
excellent opportunity for knowledge sharing no matter if you are expert in Risk
Management, interested in how to get started or anything in between.
You are welcome to forwarding this invitation to others, who may be interested
in joining our PAT CoP group. Currently our meetings are free of charge. Only
requirement for participating our meetings are, that you send your contact
information (name, e-mail and company) to mcb.at.lundbeck.com .
Kind regards
Mette Bryder
Chairman for ISPE Nordic PAT CoP
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Earlier meetings (including slides):
Design of Experiments
Agenda
Introduction to Design of Experiments, Trine
Kvist, Novo Nordisk
(Reference EVOP: Box & Draper "Evolutionary Operation", "A statistical Method
for Process Improvement", ISBN: 0-471-25551-3)
Examples of use of Design of Experiments within
manufacturing of Medical Devices, Per Vase, NNE Pharmaplan
Re-sampling - alternatives for statistical
testing?, Frans van den Berg, University of Copenhagen
Multivariate Statistical Process Control
Meeting 1st of October 2008 10:00-16:00
Agenda
Statistical testing in MSPC, Frans van
den Berg, University of Copenhagen
Applications of MSPC, Jakob Christensen,
Umetrics
Application of mechanistic models within a
PAT framework, Krist Gaernay, DTU
Towards Controlling the Solid State Properties of Pharmaceuticals, Jukka
Rantanen, University of Copenhagen
A PAT solution for fermentation monitoring,
Rasmus Bro, University of Copenhagen
PAT case studies - some experiences
June 18, 2008, 10:00-12:00 at University of Copenhagen, LIFE
10:00 - 10:05 Welcome, Per Vase, NNE Pharmaplan
10:05 - 10:40
Practical aspects of implementing PAT, Henrik Schwartzbach, Niro A/S
10:40 - 11:00 Break
11:00 - 11:30
A new
template for PAT examples, Mette Bryder, Lundbeck
11:30 - 11:55 Open discussion.
11:55 - 12:00 Subject, place and speakers for next Meeting
12:00 - 13:00 Tour at Faculty of Life Sciences
Chemometrics
Apr 24, 2008, 10:00-12:00 at Umetrics, Malmö
10:00 - 10:05 Welcome, Per Vase, NNE Pharmaplan
10:05 - 10:40 PCA, how (not) to do PCA, Rasmus
Bro, University of Copenhagen
10:40 - 11:15 PLS, how (not) to do PLS,
Marianne Toft, Umetrics AB
11:15 - 11:25 Break
11:25 - 11:55 Open discussion.
PAT sensors
Jan 23, 2008, 10:00-12:00 at University of Copenhagen, LIFE
Processanalysers, Rimmy Michan, NNE
NIR - pros and cons, Christian Zachariassen,
University of Copenhagen, Life
Design Space
Oct 25, 2007, 10:00-12:00
What is a Design Space, Jan Gustafsson, Novo Nordisk
How to use DoE for Design Space investigation, Example from tablet
manufacturing. Marianne Toft; Umetrics
IT and PAT
Meeting May 29, 2007 10:00-12:00
PAT architectures for manufacturing & development, Johan Ronsyn,
Siemens
IT
and Exploitation of Data - Analysis of Process Data, Jakob Christensen,
Umetrics AB
IT Infra Structure to Support Process Optimisation, Jesper Wagner, AN Group
Introduction to PAT
Meeting 15th of March 2007 9:00-11:00
Welcome and Introduction, Jesper Wagner, AN Group
PAT tools in
Arla Foods, Julie Johnsen, Arla Foods
PAT at Lundbeck, Mette Bryder, Lundbeck
How to get started with PAT, Alex Brindle, NNE
Quality by
design, Mette Bryder Lundbeck & Connie Heinze Novo Nordisk
PAT Toolbox, Rasmus Bro,
University of Copenhagen
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The steering committee of ISPE Nordic PAT CoP
Chairman: Mette Bryder, Lundbeck
Committee
David Karlsson, McNeil AB
Connie Langberg Heinze, Novo Nordisk A/S
Gert Ragnarsson, Medical Products Agency/EMEA
Jan Gustafsson, ISPE/Novo Nordisk A/S
Per Vase, NNE Pharmaplan A/S
Rasmus Bro, University of Copenhagen
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