Process Analytical Technology
ISPE Nordic PAT CoP

Learn about PAT and about how to implement PAT in this 'Community of Practice'

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.

• Provide a coordinated communication route from its members to and from all external parties (e.g. regulatory bodies, advisory boards, workshops, courses and speakers) 

• Provide opportunity for discussions and reviews of technical guidelines

• Efficient time management for its membership, by specifically providing a platform for: workshops, courses, symposiums, and speakers for members within Scandinavia 

• 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.

Coming meeting(s):

Dear ISPE Nordic PAT COP Member
Please book your calender already now!

Next meeting will be held on the 2^nd of June 10:00-16:00 at University of Copenhagen

The meeting will focus at experiences with PAT and QbD within the Nordic PAT CoP. We are currently working at the final agenda, and you’ll receive it a couple of weeks before the meeting, together with detailed information about meeting location. 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 PAT or QbD, interested in how to get started or anything in between. Please confirm your attendance to Per Vase (prva.at.nnepharmaplan.com) no later than 20-May.
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 prva.at.nnepharmaplan.com.

Kind regards
Mette Bryder
Chairman for ISPE Nordic PAT CoP
 

Earlier meetings (including slides):

Design of Experiments
Agenda 25th of March 10:00-16:00
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

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