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Mobile Course on QbD and PAT
Day1: Tablet manufacturing
Tuesday, February 3rd,
University of Eastern Finland, Tietoteknia building, lecture room 1035
Time
Topic
Speaker
11:45-12:15
Registration
12:15 –
Compression cycle and instrumentations beyond the force
measurement
Ossi Korhonen, University of Eastern Finland
Powder behavior under pressure
Ossi Korhonen, University of Eastern Finland
Physical and pharmaceutical tablet analysis
Ossi Korhonen, University of Eastern Finland
14:00 – 14:30
Break
14:30 -
Scale-up of tablet manufacture
Jari Pajander, Novo Nordisk
Future of tablets (novel tablets)
Jari Pajander, Novo Nordisk
Discussion, Q&A
Ossi Korhonen, Jari Pajander, Jarkko
Ketolainen
16:30 – 17:00
Mobile Course on QbD and PAT
Day 2: Implementation of QbD and PAT
Wednesday, February 4th
University of Eastern Finland, Tietoteknia building, lecture room 1035
Time
Topic
Speaker
9:15 – 9:30
Opening of Day 2
Professor Jarkko Ketolainen
9:30 –
Setting the Scene for Quality by Design
Line Lundsberg, Lundsberg Consulting Ltd
Practical PAT program development
Line Lundsberg, Lundsberg Consulting Ltd
11:30 – 12:30
Lunch
12:30 –
Application of PAT in QbD
Line Lundsberg, Lundsberg Consulting Ltd
Process analyzers and process data analysis
Line Lundsberg, Lundsberg Consulting Ltd
14:15 – 14:45
Break
14:45 –
PAT and quality risk management
Kevin O’Donnell, Health Products Regulatory
Authority
Regulatory view of QbD and future prospects
Kevin O’Donnell, Health Products Regulatory
Authority
16:30 – 17:00
Discussion, Q&A and closing of the workshop