ISPE Conference on Product and Process Quality
Innovations in OSD Processing
Monday 15- Tuesday 16 September 2008Manchester, United Kingdom
Seminar Leaders:
Ulrika Henningson, AstraZeneca (Sweden)
Trevor Page, Niro Pharma (UK)
• Learn about new technologies in OSD manufacturing
• Discover innovations in containment and potent product material
• Explore the impact of potent compounds on cleaning
Quality by Design requires innovative thinking. Industry and Regulatory authorities are now using channels like the new Annex to ICH Q8 Pharmaceutical Development guidance and ISPE's PQLI initiative to paint a picture of an industry which will be significantly different in the future.
This picture will demand new and innovative approaches to product design, product specifications, process design and process control. While some of these changes may be novel in our industry, there is much we can learn from techniques which have been well proven to help other industries achieve world class 6 sigma production capabilities. With speakers from a range of backgrounds, this seminar will provide information about innovations from academia and industry, as well as take a broader view of techniques and technologies which are already currently employed in other industries, and which have the potential to improve pharmaceutical development and manufacturing.
Examples of Quality by Design will be given, to show what it means to develop enhanced processes. Some of these examples will be based on work conducted in other industries. The seminar will include practical sessions, case studies, and an interactive workshop, all of which will inspire delegates to implement Quality by Design in their own organisations.
Take Back To Your Job:
• An understanding of the four pillars of QbD: Product Performance, Product Design, Process Design and Process Performance.
• New and updated information on the technologies available for OSD processing
• Insights into optimising your existing OSD procedures
• Understanding how emerging trends in OSD may affect the design of your new facilities or introduction of new processes onto your site
Agenda
Monday, 15 September
10.00 – 10.15 Introduction and Welcome
Ulrika Henningson, AstraZeneca (Sweden); Trevor Page, Niro Pharma (UK)
10.15 – 11.00 Case Study 1: Design Space – Astra Zeneca
Speaker to be confirmed
11.00 – 11.45 Case Study 2: Design Space
Speaker to be confirmed
11.45 – 12.30 Nano-chemical Approaches to Controlled and Targeted Drug Delivery
Speaker to be confirmed
12.30 – 14.00 Lunch
14.00 – 14.45 Lyopan – A lyophilization technology for producing fast melting tablets
Speaker to be confirmed
14.45 – 15.30 Continuous Processing of OSD
Speaker to be confirmed
15.30 – 16.00 Coffee
16.00 – 16.45 Britest – a Scientific Approach to Process Design
Speaker to be confirmed
16.45 – 17.30 DEM Modelling
Speaker to be confirmed
17.30 – 18.00 Discussion, Q & A
Ulrika Henningson, AstraZeneca (Sweden); Trevor Page, Niro Pharma (UK)
Networking Reception
Tuesday, 16 September
09.00 – 09.15 Recap of Day 1 – Introduction to Day 2
Ulrika Henningson, AstraZeneca (Sweden); Trevor Page, Niro Pharma (UK)
Speaker to be confirmed
10.00 – 10.30 Coffee
10.30 – 11.15 Case Study 4: Real-time Release (AstraZeneca)
Speaker to be confirmed
11.15 – 12.00 Real Time Statistical Process Control
Speaker to be confirmed
12.00 – 13.30 Lunch
13.30 – 14.15 Real Time Performance Management in the Food Industry
Speaker to be confirmed
14.15 – 15.00 QbD and ISPE OSD Baseline® Guide
Speaker to be confirmed
15.00 – 15.30 Discussion, Q & A – Chair’s Seminar Close
Speaker to be confirmed