PAT & QbD brochure (PDF) - JMP

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Pre-Conference Workshops: 18th January 2010 Workshop A: 10.00-13.00 Application of PAT and QbD for Biopharmaceuticals With PAT and QbD having a more established hold within the small molecules arena the focus is now turning towards the more complex Biopharmaceutical sector. This interactive workshop will discuss the different stages and important considerations focusing on the practical application of PAT and QbD principles for drug design and manufacture. Attendees will have the chance to discuss case study examples as well as work within smaller groups for more targeted discussions. Workshop Leader: Dr Victor A. Vinci, Director, Bioprocess Operations, Eli Lilly and Company Meet your workshop leader Dr. Vinci is currently Director of Bioprocess Operations at Eli Lilly and Company in Indianapolis, Indiana. As such, he is responsible for process operations focused on bringing new protein therapeutics to market by producing active pharmaceutical ingredients intended for clinical trials. For the last 4 years, his responsibilities have included coordination of teams involved in the design, commissioning and qualification of a new 200,000 sq ft cGMP bulk process facility, developing staffing models, and implementing effective and compliant operational practices. His team is currently engaged in tech transfer for new campaigns, bioprocess operations to produce bulk biologic API, and improving platform operations for bioproducts. He serves as the lead for the Lilly team involved with the CMC Biotech Working Group (industry consortium) which has finished a QbD case study for a monoclonal antibody (Mab). Prior to his current role, he was a scientist and group leader in process development at Eli Lilly for five years. He began his career at Merck where he was a scientist and later section head in an Manufacturing Science and Technology (MS&T) role. Dr. Vinci received his doctorate in Microbiology from The Ohio State University in 1988. Workshop B: 14.00-17.00 De-mystifying Regulatory Submission for PAT and QbD This interactive workshop will allow you to assess successful and unsuccessful FDA and EMEA submissions as well as giving attendees the opportunity to discuss openly their own experiences and gather fresh ideas on how they can change their approach for the better. Workshop Leader: Gerald DiDonato, Associate Director, Global Regulatory Sciences CMC, Bristol Myers Squibb Meet your workshop leader Gerald DiDonato, Associate Director, Global Regulatory Sciences-CMC, received his PhD in Analytical Chemistry with a specialty in mass spectrometery from Indiana University in 1987. Gerald joined Bristol-Myers Squibb as a Research Investigator solving structure elucidation problems for Discovery, Development and Manufacturing colleagues. He was one of the first to use electrospray mass spectrometry as a routine structure elucidation tool in the Pharmaceutical Industry. Subsequently he managed multidisciplinary analytical groups, and led Development and Manufacturing Teams for new products. Gerald recently chaired the Company's Specification Committee. He saw the light and switched to Regulatory Affairs in 2005, where he currently is the CMC lead for saxagliptin as well as several products in development. About Pharma IQ Become a member of Pharma IQ and receive complimentary access to resources that will keep you at the forefront of industry change. You will receive access to our growing library of multi-media presentations from industry leaders, an email newsletter updating you on new content that has been added, free aggregated news feed from over 1000 global news sources tracking your industry and special member only discounts on events. Become a member here: Web: www.pharmaceuticaliq.com Phone: +1-646-454-4559 www.patandqbd.com CALL: +44 (0)20 7368 9300 / 0800 652 2363 FAX: +44 (0)20 7368 9301 EMAIL: enquire@iqpc.co.uk
Conference Day One: 19th January 2010 08.50 Pharma IQ Welcome and Chairperson’s Opening Address 09.00 Opening Presentation: EU Regulatory Perspective of PAT Technology and Inspections Visit www.patandqbd.com for updates Des Makohon, Senior GMP Inspector, MHRA. Member, PAT Team, EMEA 09.45 Case Study: Filing a QbD Submission Across the Globe • Outline of the product (saxagliptin, trade name Onglyza) and the joint file process • Highlighting the problem areas experienced throughout the application process • How were these challenges approached and overcome? Analysing the feedback from the different regulatory authorities across the globe Gerald DiDonato, Associate Director, Global Regulatory Sciences CMC, Bristol Myers Squibb 10.30 Process Understanding: The Key to a Successful QbD or PAT Implementation. To properly design quality into your product you need to understand the relation between functional requirements and design parameters. At the same time, the relationship between the design parameters and process parameters provides the basis to properly control the manufacturing process used to realize your product design. QbD combines both aspects, and holds the promise of reduced time to market and increased market share. In this session you will: • See how Design of Experiments (DoE) allows you to rapidly gain secure knowledge of the two types of relationships fundamental to QbD. • Discover how easy to use software packages, like JMP from SAS, have made DoE a tool for engineers, not just for statisticians. • See several real-world examples of the use of DoE within QbD initiatives in the pharmaceutical and biotech industry Dr Per Vase, Senior Specialist, Consulting, NNE Pharmaplan 10.50 Networking Coffee Break 11.20 Multivariate Statistical Process Control: Moving Towards Model Based Approaches • The challenges of capturing, analysing and monitoring with real time dynamic data • Understanding why process dynamics and dynamic multivariate monitoring are important to assured pharmaceuticals development and manufacturing • Analysing the role of dynamics in PAT and QbD in achieving RTR • Increasing process understanding using advanced PAT tools Professor Julian Morris, Technical Director, CPACT 12.00 Ensuring Efficient QbD and PAT Implementation PAT and QbD has left the initial phase and the question that companies face now is how to implement PAT and QbD in an efficient way rather than if it is possible. Umetrics will talk about common themes in projects which have reached their goals within the given timeframe and budget including: • The importance and use of risk analysis, FMEA • Understanding when and how to employ multivariate methodology • The benefits of involving QA at an early phase to avoid delays in the implementation and validation phase Examples range from DoE based development projects all the way to validated multivariate on-line installations. Petter Morree, Director, Online Products, Umetrics AB 12.45 Networking Lunch Break 14.00 Case Study: Using NIR PAT Application to Reduce Risk of Scale-Up This case study will demonstrate how a simple PAT application reduced the risk to critical Quality Attributes of scaling up a Unit Dose process Ayub Khan, Process Technologist, Napp Pharmaceuticals 14.45 Case Study: Robust Method for the Determination of Caffeine in Intact Tablets by Near-infrared Spectroscopy • Development of a method for the determination of caffeine in intact tablets • Effect of the sample size on the predictive ability of the developed calibration model • Effect of the sample variance (variable compression force) on the predictive ability of the developed calibration model • Comparison between diffuse reflectance and diffuse transmittance NIR sampling Branko Vranic, PhD Student and Teaching Assistant, Industrial Pharmacy Lab, University of Basel 15.30 Networking Coffee Break 16.00 Gathering Data to Support QbD • Importance of Product Definition and Process Mapping • Risk assessment process: Subjective vs. statistical data, use of FMEA and Cause+Effect Matrix • Use of measurement systems to gather data during DoE: Measured vs. Measurement Variance • Use of PAT to drive process control Martin Warman, Scientific Fellow, Analytical Development, Vertex Pharmaceuticals 16.45 Case Study: Application of QbD/PAT on a Commercial Product: Quality by Re-Design • The reason why we are trying to implement PAT will also be shown to be the handling of the incoming variability in order to deliver predefined quality each and every time • The utilisation of Quality Risk Management tools for finding the Critical Process Parameters. This includes Fishbone diagrams and FMEA’s • Why IT and Automation infrastructure are necessary for using MVDA during manufacturing • Outlining the need for MVDA in manufacturing as a confirmation of the established design space will be described Dr Hedinn Valthorsson, Manufacturing Manager, Novartis 17.30 Break-Out Round Table Discussions Participants will be able to choose between the different roundtables and spend 45 minutes discussing the points outlined below before feeding back to the group A: The Use of Lean and Six Sigma Initiatives with PAT when Striving for Operational Excellence Martin Warman, Scientific Fellow, Analytical Development, Vertex Pharmaceuticals B: Successfully Using Quality Risk Management to Establish CQAs Zadeo Cimarosti, Manager, Chemical Development, GlaxoSmithKline Verona, Italy C: Should You Build in QbD Before or After Proof of Concept Michael Schousboe, Senior QbD Manager, Manufacturing Science and Quality, Novo Nordisk D: Successfully Creating and Controlling a Secure Design Space Dr Barry Gujral MBA, Associate Director, Quality Engineering, Noven Pharmaceuticals Inc. E: How to Approach QbD in Biopharmaceuticals Victor A. Vinci, Director, Bioprocess Operations, Eli Lilly and Company 18.30 Chairperson’s Closing Remarks and Close of Day One CALL: +44 (0)20 7368 9300 / 0800 652 2363 FAX: +44 (0)20 7368 9301 EMAIL: enquire@iqpc.co.uk
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