ISPE Conference on Product and Process Quality
PAT Data Management - Impact on Business Processes Used for Improving Product and Process Quality
Wednesday 17- Thursday 18 September 2008Manchester, United Kingdom
Christian Woelbeling, Werum Software and Systems AG (Germany)
Line Lundsberg-Nielsen, NNE Pharmaplan (UK)
• Understand PAT data management in relation to the PAT Guidance, ICH Q8, Q9 and Q10
• Learn from companies using PAT data management to improve business processes and product quality
• Debate and discuss with all European Regional PAT COPs
One of the challenges resulting from the PAT initiative is what to do with all of the additional data that is being generated and how to use these data for quality and other business decisions. This session looks at the progress that has been made in supporting the manufacturing processes utilising PAT generated data.
It concentrates on the business challenges in implementing PAT systems to design, analyse, and control manufacturing operations to improve the processability and product quality. Case studies will help delegates understand how companies have utilised data management throughout their development and manufacturing environment as well as discussing the challenges of integrating these data in the business processes.
A full day will be devoted to PAT data management. A half-day will consider how PAT can be applied to make better business decisions. A further half-day will involve an interactive European Community of Practice (COP) meeting, which will give participants the opportunity to discuss PAT implementation with equally minded scientists. It will also give them valuable information which they can take back to their local COP to work on PAT issues in more detail.
Take Back To Your Job:
• Understand the data management needed to implement PAT
• Justify data management PAT projects in your organisation knowing the drivers and benefits
• Know how to structure, initiate and implement PAT data management projects based on presented case studies
• Understand how PAT data can be used in business processes and in quality decisions
• Generate a PAT network of people in the same situation as you
10.00 – 10.15 Welcome and Introduction
Christian Woelbeling, Werum Software and Systems AG (Germany); Line Lundsberg-Nielsen, NNE Pharmaplan (UK
- What is PAT data
- How do want to use PAT data
- What is a PAT data management system
- What are the requirements to a PAT data management system
11.30 – 12.15 Categorisation of PAT Data
Julian Morris, CPACT Uni (UK)
- What type of data?
- What kind of data adds value to the business
- What kind of data do we need for PAT models
13.15 – 14.00 Analytical Device Integration for PAT
Thomas Buijs, ABB (USA)
- What type of analysers need to be integrated
- Analyzer connectivity, current status
- Future requirements for integration of analyzers
- Future vision of analyser device integration
- PAT data management framework in R&D and in operation
- Mapping the PAT technology framework to ISA-S95
- Applying PAT data management for real-time analysis
14.45 – 15.30 Analysing and Organising Complex Datasets using Multivariate Data Analysis
Petter Möréen, Umetrics (USA)
- Data management for development and visualization of Design Space
- Multivariate characterization of batch processes
- Mapping the process to product quality
15.30 – 16.00 Coffee and Networking Break
16.30 – 16.45 Managing the PAT Data in OSD (Orals Solid Dosage) projects at AstraZeneca
Ulrika Henningsson, Astra Zeneca (Sweden)
- Applying PAT to existing OSD processes
- Identifying & Capturing relevant PAT process data
- Evaluating PAT data for business process optimisation
16.45 – 17.00 Question and Answer Session – Chair’s Seminar Close, Day 1
Christian Woelbeling, Werum Software and Systems AG (Germany); Line Lundsberg-Nielsen, NNE Pharmaplan (UK
09.00 – 09.15 Recap of Day 1 – Introduction to Day 2
Christian Woelbeling, Werum Software and Systems AG (Germany); Line Lundsberg-Nielsen, NNE Pharmaplan (UK
09.15 – 10.00 PAT Data Management in a |Bio-pharmaceutical Facility
David Lovett, Perceptive Engineering Ltd. (UK)
- The need for robust real-time data management
- What do other industries do?
- Data – The Good, The Bad and the Ugly!
- Case study – Biological Process
- Integrated data & process monitoring with control
10.00 – 10.45 The Necessity of PAT and Data Management during Late-stage Product Development at Wyeth
David Gibson, Wyeth (UK)
- Overview of pharmaceutical and R&D landscape
- Challenges and opportunities of late-stage development
- PAT tools – from data to knowledge to business benefit
10.45 – 11.15 Coffee and Networking Break
11.15 – 12.00 Establishing a data management system for QbD and PAT at Novartis
James Cheney, Novartis (USA)
- Data collection strategy
- Novartis PAT project structure
- Integrated solutions
12.00 – 13.00 Lunch and Networking Break
13.00 – 13.45 PAT Data Quality Risk Management at GSK
Phil Litherland, GSK (UK)
- Quality risk assessment applied for PAT data management
- Risk-based data monitoring
- Linking ICH Q9 to design your data management system
13.45 – 15.15 PAT COP Interactive Workshop
Speaker to be confirmed
- How to apply PAT into different unit operations
- Introduction: PAT case studies for API and secondary
- Manufacturing based on the ISPE PAT COP template approach
15.15 – 15.30 Question and Answer Session – Chair’s Seminar Close
Christian Woelbeling, Werum Software and Systems AG (Germany); Line Lundsberg-Nielsen, NNE Pharmaplan, Denmark