Process Analytical Technology - June 14-17, 2005 - Philadelphia, PA
Process Analytical Technology
June 14-17, 2005 - Philadelphia, PA
Doubletree Hotel - Philadelphia, PA
Pre-Conference Half Day Interactive Workshops
Interactive Workshop A
8:30 AM - 12:00 PM
Multivariate Analysis, Pilot Projects, and Risk - How to Best Approach Your PAT Initiative
James Cheney, PAT Team Project Leader, Novartis
Chris Ambrozic, Senior Consultant, Umetrics Inc.
This workshop will focus on data analysis and integration as presented from the perspective of both the end-user and the vendor. Lessons will be drawn on proper data decisions, analysis, risk management, and project management from real-world applications and references.
Interactive Workshop B
8:30 AM - 12:00 PM
Achieving Mechanistic Understanding through Solid State Chemistry during Drug Development
Jessica K. Liang, Ph.D., Research Investigator, SSCI Inc.
I. Overview of PAT Implementation in Development
- What is PAT approach with respect to the conventional approach?
- Where are the opportunities and the subsequent benefits?
- PAT implementation strategy
- Quality by design
II. PAT Implementation in Crystallization Processes
- Understanding the crystallization process and how it affects the process development and final product quality
- Utilization of multiple in-line sensors (Raman and FBRM) to achieve process understanding: a complex polymorphic system
- Chemical engineering aspects: hydrodynamics, heat transfer & scale-up (the missing link between lab scale and production scale) (optional)
III. PAT Opportunities in Downstream Processes
- How to improve filtration process via mechanistic understanding of particle size
- In-line sensor development (Raman) for drying process
- PAT is not always about in-line sensors: a small scale PAT case on a complex drying/polymorph conversion study
Interactive Workshop C
8:30 AM - 12:00 PM
Selection, Adoption, and Validation Process for a PAT System
Normand Dubuc, P.Eng., Senior Director of Automation, Pharmaceutical Solutions, Invensys Validation Technologies
Tracy Davis B.Sc., Sr. Project Manager, Invensys Validation Technologies
Nancy Mathis, Ph.D., P.Eng, President and CEO, Mathis Instruments Ltd
I. Review of Standards and Regulatory Guidelines on PAT
- FDA - GAMP 4
- ASTM - USP
II. Example of a PAT Implementation: Effusivity on a Fluid Bed Dryer
- Mechanical interface retrofit
- Software integration/retrofit
- Sample introduction process
- Sample profiles
- Correlation to existing method(s)
III. Dealing with the Output Data: Control
- Establishing a control criteria
- Monitor or control in an open loop
- Multi-step control in a closed loop
IV. Seeking Regulatory Approval
- Regulatory risk versus data use
- How many batches now that 'three' is not the answer?
- Parallel testing and working toward PAT data reliance
- Expected timelines and schedule
- Outline of a filing
- What to expect during a PAT inspection
V. Interactive Exercise: Developing Documents
- Users will complete a SWOT analysis of the approach described for their own organizations. The strengths, weaknesses, and opportunities or threats (risks) will be discussed to establish areas that should be clarified by the regulatory or standardization groups to remove ambiguity.
Interactive Workshop D
8:30 AM - 12:00 PM
Managing a PAT Technology Program - From Business Case to Portfolio Management
Loren Buhle, Ph.D, Associate Partner, IBM Business Consulting Services
Moira Gilchrist, Ph.D., Management Consultant, IBM Business Consulting Services
I. The Role of PAT in Pharmaceutical Development
- Understand the challenges in pharmaceutical development
- Investigate the benefits of preferred technologies
- Identifying the steps to mechanistic understanding
- Applying PAT
- Understanding the role of data feedback from manufacturing
II. Articulating the Business Value of PAT Technologies
- Understand the basic value drivers
- Learn why the business likes reduced uncertainty
- Understand why manufacturing flexibility and responsiveness are needed
- Calculate the reductions in operating costs
- Practice getting the arguments into senior management language
III. Managing a PAT Technology Program
- Categorize PAT projects across three dimensions
- Assign relevance of projects to strategic business drivers
- Review critical success factors and their impact on the projects
- Communicate the results in graphical form
- Recommend "go/no go" decisions
IV. Interactive Exercise: Participants will use the PAT Technology Workbook to characterize the on-going PAT initiatives in their organizations, and plot them on a portfolio grid allowing prioritization, alignment and escalation.
V. Toolkit: Participants will receive a PAT technology workbook that they can use in their own organizations to manage PAT technology programs. They will also receive a copy of Transforming Industrialization - a New Paradigm for Pharmaceutical Development, and a Flash CD on Quality-by-Design. This material will help participants communicate with their senior management.
12:00 PM - Luncheon for Workshop A, B, C, D Attendees
Tuesday, June 14, 2005
Pre-Conference Half Day Interactive Workshops
Interactive Workshop E
1:30 PM - 5:00 PM
The Role of Raman Spectroscopy in the PAT Initiative
Mark Kemper, MSc., International Sales Manager, Kaiser Optical Systems, Inc.
Ian R. Lewis, Ph.D., Marketing Manager, Kaiser Optical Systems, Inc.
I. Raman Spectroscopy
- Brief overview of the discovery and historical background
- Theoretical basis of the Raman effect
- Comparison of Raman vs. other spectroscopic tools
- Advantages of Raman spectroscopy as a non-destructive analytical tool
II. Instrumentation for Raman Spectroscopy
- Learn about the breadth of implementation possibilities for Raman - From discovery to manufacturing
- Understand modern instrumentation and how to apply these devices
- Using Raman as a qualitative and quantitative tool
- Rendering spectral data into information
III. General Applications of Raman Spectroscopy
- See where Raman microscopy and imaging are applied
- Reaction monitoring for analysis, understanding & control
- Crystallization studies
- Polymorphic form identification in primary manufacturing
- Raman's role in secondary manufacturing
IV. Specific Cases Studies
Interactive Workshop F
1:30 PM - 5:00 PM
Implementing PAT with a Four-Step Methodology
John Davis, President, Lloyds Register Serentec, Inc
This workshop provides participants with an in-depth understanding of a practical four-step methodology developed by Lloyd's Register Serentec for supporting PAT in a manner consistent with FDA's draft guidance. Participants will learn to apply this methodology during an interactive exercise.
I. Discover
- Analyze proposed or existing process
- Identify key critical control points
- Identify potential PAT opportunities
- Develop PAT plan
II. Develop
- Develop statistical models
- Conduct experimental studies
- Identify analytical technology solutions
III. Demonstrate
- Substantiate statistical correlations
- Demonstrate technological capability
- Assemble PAT Dossier
IV. Deploy
- Implement procedural changes
- Perform continuous monitoring and analysis
- Replicate success
V. Interactive Exercise
Learn to apply this PAT Methodology
Interactive Workshop G
1:30 PM - 5:00 PM
Quantitative Process Characterization: A First and Important Step of a Successful PAT Program - A Structured and Proven Methodology and Case Studies
Philippe Cini, Ph.D., PAT Program Leader, Tunnell Consulting
Lawrence K. Meyers, Senior Statistician and Principal, Tunnell Consulting
John K. Masselink, Director of Pharmaceutics at Purdue Pharmaceuticals
I. PAT Industry Interpretation and Trends
- Review and discuss industry survey results on interpretation of PAT draft guidance
- Gain insight into PAT implementation approaches taken by different pharmaceutical companies
- Identify key elements of a comprehensive PAT implementation plan
II. Quantitatively Characterize a Manufacturing Process
- Review a structured and proven methodology to achieve quantitative process characterization
- Learn to apply this methodology to commercial manufacturing processes (abundant data) and to processes under development (limited data)
- Discuss the value of a cross-functional team approach to process understanding
III. Process Characterization Tool Box
Learn to use a series of qualitative and statistical investigation tools
- Focus interviews
- Database design
- Cpk and control charts
- Bivariate analysis
- Multivariate regression analysis
- Table of effects
- Confirmatory trials
- Screening and optimization DoEs
Note: Please visit the Website for extensive information regarding these Conference Workshops.
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