PAT & QbD brochure (PDF) - JMP

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Conference Day Two: 20th January 2010 08.45 Chairperson’s Opening Remarks 08.55 KEYNOTE PRESENTATION Case Study: Development of a Monoclonal Antibody Using QbD: Results from the Industry Consortium • Overview of the case study describing monoclonal antibody development from molecule design through validation • Examples of risk assessment strategy and tools used • Examples of the use of prior platform knowledge and experimental design for mammalian cell culture and protein purification • The analysis leading toward critical quality attributes (CQAs) and control strategy • A proposal for design space and lifecycle management of the process and product Dr Victor A. Vinci, Director, Bioprocess Operations, Eli Lilly and Company 09.40 Using QbD Approaches to Enable Development of Real-Time-Release for a Continuous Drug Product Process • Discussion of the QbD risk management approaches used at Pfizer • Generation of process understanding and design space capable of supporting a QbD filing • Moving from batch processing to continuous processing for Pharmaceutical drug products • Implementation of CQV and RTR in pharmaceutical manufacturing at Pfizer David Sharp, Senior Principal Scientist, Pfizer 10.20 Business Case on the use of PAT in an Oral Solid Dosage Pilot Plant • Outlining a successful PAT implementation in an Oral Solid Dosage Pilot Plant • Overcoming some of the key challenges in putting a PAT strategy into practice • Discussion of how PAT has contributed towards cost saving objectives by helping speed up the development process and shorten the production time Patrick Bossuyt, SIPAT Sales Executive, SIEMENS 11.00 Networking Coffee Break 11.30 Case Study: Developing a Successful Change Management Approach When Implementing QbD in a Global Company • How do you approach implementing new concepts like QbD within the wider business • Overcoming the challenge of change by illustrating the benefits and securing buy in. • Ensuring the business keeps running with both current and new paradigm’s during implementation • Preparing for when QbD is part of how we run the business Michael Schousboe, Senior QbD Manager, Manufacturing Science and Quality, Novo Nordisk 12.10 Case Study: Application of QbD in Development: Building the Control Strategy for Drug Substance Critical Quality Attributes in the Manufacturing Process of a Drug Substance The quality by design approach adopted for the definition of the control strategy for a drug in development is described. Details are given on: • The risk assessment done to identify the potential quality critical process parameters • The multivariate and univariate process studies undertaken to assess the potential quality critical process parameters • The specification controls on the input materials All these elements of control combined together, allowed the definition of a robust control strategy with the potential to remove the “endproduct testing” for some drug substance-CQAs. Zadeo Cimarosti, Manager, Chemical Development, GlaxoSmithKline Verona, Italy 12.50 Panel Discussion: Integrating QbD principles into your Lifecycle Management Programme • Discussing the benefits of integrating the two initiatives • How can this actually be done? What are the first few steps? David Sharp, Senior Principal Scientist, Pfizer Zadeo Cimarosti, Manager, Chemical Development, GlaxoSmithKline Verona, Italy Michael Schousboe, Senior QbD Manager, Manufacturing Science & Quality, Novo Nordisk Philippe Cappuyns, Pharmaceutical Technology Director, Janssen Pharmaceutica 13.20 Networking Lunch Break 14.20 Case Study: Developing a Strong Business Case for QbD Implementation Within a Contract Manufacturing Company • Outlining the challenges faced by a CMO • Discussing the benefits of using QbD in customer projects • Highlighting some of the difficulties faced and how these were overcome Hans ter Maat, Senior Process Engineer, DSM Biologics 15.00 Case Study: Model-based QbD Development Integrated in a Product Life Cycle Management Approach • The presentation will provide a systematic and proactive QbD development approach enabling to meet current ICH Q8, Q9 and Q10 guidelines • The characteristics of a model-based QbD development methodology and the resulting benefits will be highlighted • The presentation will cover the integration of QbD into a Product Life Cycle Management approach and its business value Philippe Cappuyns, Pharmaceutical Technology Director, Janssen Pharmaceutica 15.40 Networking Coffee Break 16.10 Case Study: Delivering Robust Manufacturing Processes Using a Structured Critical Process Parameter workflow • Exemplification of the GSK API critical process parameter workflow • Workflow essentials: Planning, process understanding, performance, uncertainty, risk and control • Making it happen, adding value Martin Owen, Manager, GlaxoSmithKline 16.50 Case Study: Implementing PAT and QbD at the Formulation Stage • Outline the challenges faced when implementing these tools earlier in the life cycle • Discussion of key examples used in transdermal drugs • Risk analysis study using these tools • Comparison of predictive and observed results Dr Barry Gujral MBA, Associate Director, Quality Engineering, Noven Pharmaceuticals Inc. Peter Amanatides, Vice President QA and QC, Noven Pharmaceuticals Inc. 17.30 Chairperson’s Final Remarks and Close of Conference CALL: +44 (0)20 7368 9300 / 0800 652 2363 FAX: +44 (0)20 7368 9301 EMAIL: enquire@iqpc.co.uk
Session Sponsor Conference Sponsors Session Sponsor Session Sponsor Umetrics – Value from Data. Since 1987, Umetrics' mission has been to ensure that clients add value to their businesses through the use of advanced data analysis and experimental design software and services. Umetrics is the worldwide recognized leader in the area of multivariate data analysis for industrial R&D, processes, PAT, QbD and applications. Umetrics customers have proven many times that the use of Umetrics technology and services have generated significant added value by optimizing processes through generation of reliable information from complex data. Umetrics offers a complete solution for PAT and QbD applications in the area of Design of Experiments and Multivariate Data Analysis. Our offering to industry covers software products for model building and troubleshooting to real-time software solutions for process monitoring and control enabling e.g. RTR – Real Time Release. Training services, support and projects are important parts of our offering. Umetrics train more than 1000 scientists and engineers per year in DoE and MVDA. Umetrics have offices in US *3, UK, Sweden*2, Singapore and Japan. Phone: +46 40 664 25 80 Fax: +46 40 664 25 85 Email: info@umetrics.com Web: www.umetrics.com Gold Exhibitor Büchi is a privately held company in the eastern part of Switzerland. It was founded in 1939 as a glass blowing workshop. High-tech glass instruments for the use in chemical laboratories are still one of the core competencies of Büchi. In the meantime, Büchi is a world-wide supplier in key technologies such as evaporation and separation for research laboratories as well as near infrared spectroscopy and reference methods for quality control purposes. From ergonomic laboratory equipment to the solution of complex analytical problems in the high-tech sector, Büchi provides practical support in the chemical laboratory. And in its own research and development laboratory, Büchi works constantly on solutions for customer problems in the areas of Nutrition, Life Sciences and production in the pharmaceutical and chemistry related industry. Phone: +41 71 394 63 63 Fax: +41 71 394 65 65 Email: info@buchi.com Web: www.buchi.com Siemens Industrial IT develops and implements software solutions in the domains specification management (PLM), lab and quality management (LIMS), MES, PIMS, SCADA, EPMS and metering. Our offering includes a solution for PAT and QbD in the pharmaceutical industry, based on SIPAT. This software solution has been developed in close cooperation with the FDA to support PAT implementation efforts and the use of PAT tools in development and manufacturing. It is successfully operational at GSK, Merck, Wyeth and Ferring. What is SIPAT ? • SIPAT increases process understanding and allows continuous process improvement during manufacturing operations and process development. • SIPAT enables monitoring and consolidation of product quality information, allowing real-time quality decision making • SIPAT enables (advanced) process control whereby it can either focus on specific Unit operations or it can cover total batch quality to enable Real-time Product Release. • SIPAT serves as the common interface for all PAT tools. Web: www.swe.siemens.com/belux/sipat/en JMP is a business unit of SAS Institute, the largest privately held software company with revenues exceeding 2 Bn$. JMP and JMP Genomics are software products that allow scientists, engineers, and business users to easily get value from their data through “statistical discovery”. JMP has been under development for 20 years, and is used globally. Web: www.jmp.com Testimonials “Really enjoyed the case examples when a good level of detail was presented. Has been very useful to understand current status as perceived by industry & network with colleagues.” Andy Townsend, AstraZeneca “Very good. Good update and information on current state of QbD & PAT. A good general overview of what design space is to pharma.” Steven Brown, Wyeth Sponsorship Opportunities Sponsoring the 7th Annual PAT and Quality By Design Forum will deliver: 1. Networking opportunities enabling you to sell directly to, and meet with, key budget holders who had invested considerable time and money to attend this event and address their business challenges 2. A platform from which to demonstrate your technology and thought-leadership to your target market 3. Brand awareness amongst your target market, keeping your company front of mind for both your current and prospective clients Pharma IQ’s 7th Annual PAT and QbD event deals with the current challenges and success stories from within the pharmaceutical arena, bringing together the key decision makers and innovative minds within the field. Contact Gal Cohen on +44 (0) 20 7368 9300 or sponsorship@iqpc.co.uk and she will be able to discuss with you your business goals and how we can help you achieve them CALL: +44 (0)20 7368 9300 / 0800 652 2363 FAX: +44 (0)20 7368 9301 EMAIL: enquire@iqpc.co.uk
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PAT & QbD brochure (PDF) - JMP

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