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June 17, 2010
Effective Application of Quality-by-Design in Pharmaceutical Development and Product Manufacture
Keynote Speaker for this event:
  • Kwok Chow, Ph.D., Senior Director Global Pharmaceutical Development Technology and Alliances, Patheon  Learn More
  • Effective Application of Quality-by-Design in Pharmaceutical Development and Product Manufacture

    Quality-by-Design (QbD) is a useful tool to enhance quality, reduce risks and capitalize opportunities.

    QbD involves the use of material science, effective design/execution of experimental programs, application of suitable technologies and team work at all stages of pharmaceutical product development and manufacture.

    Applying material science concepts as well as material sparing technologies at pre-formulation helps define development strategies and quality attributes.

    Judicious collection of solid-state data supports risk assessment, identifies formulation options, and therefore avoids downstream clinical, CMC and timeline issues. It can also prevent costly mistakes in formulation development and scale-up.

    QbD is more effective when a development program is executed using appropriate experiments that are designed with careful consideration of the nature of the chemical entities involved, type of statistical methods to be employed, resource to be available, and appropriate pharmaceutical technologies including process analytical technologies (PAT) to be applied, and intended product characteristics. This multidisciplinary approach often produces better results especially when statistical design of experiment is involved.

    It is important to note that QbD extends beyond formulation and process development. On-going monitoring of the manufacturing process, a vigorous continuous improvement program and commitment to quality are critical to maintain the success of a QbD program.

    THIS PROGRAM IS INTENDED FOR:

    Senior level executives in R&D, Pharmaceutical Development and Clinical Supply functions for pharmaceutical/biotech companies worldwide

    ABOUT OUR SPEAKER:

    Kwok Chow, Ph.D., Senior Director Global Pharmaceutical Development Technology and Alliances, Patheon  

    Dr. Chow joined Patheon as Director, Formulation Development in 2001. He has been serving as the Senior Director of Global PDS Technology and Alliances since 2005. He is responsible for developing/introducing new technologies, establishing strategic technology-alliances and providing scientific input for the pharmaceutical development of challenging molecules.

     

    Prior to joining Patheon, Dr. Chow spent 13 years at GlaxoSmithKline (previously Glaxo Wellcome and Glaxo) where he was leading the formulation design and development of a variety of conventional and novel dosage forms. He also played a CMC leadership role in the development of new chemical entities and line extension products for North America, Europe, Australia/New Zealand, Japan and other Asian Pacific countries.

     

    Dr. Chow received his B.S. in Pharmacy from the University of Minnesota and his Ph.D. in Industrial Pharmacy from Professor David Grant at the University of Toronto on crystal engineering of drugs. Dr. Chow taught formulation development classes at the University of Toronto. He also supervised industrial graduate students. He has conducted research to study enabling technologies for quality-by-design and on electrostatic dry powder coating.

     

    He is the author of a number of patents, abstracts and research/review articles.

    ABOUT OUR SPONSORING PARTNER:

    Patheon is a leading global provider of contract development and manufacturing services to the global pharmaceutical industry. Patheon prides itself in providing the highest quality products and services to approximately 300 of the world’s leading pharmaceutical and biotechnology companies. Patheon’s services range from preclinical development through commercial manufacturing of a full array of dosage forms including parenteral, solid, semi‐solid and liquid forms. Patheon uses many innovative technologies including single‐use disposables, liquid‐filled hard capsules and a variety of modified release technologies. Patheon’s comprehensive range of fully integrated Pharmaceutical Development Services includes pre‐formulation, formulation, analytical development, clinical manufacturing, scale‐up and commercialization. Patheon can take customers direct to clinic with global clinical packaging and distribution services and Patheon’s Quick to Clinic™ programs can accelerate early phase development projects to clinical trials while minimizing the consumption of valuable API. Patheon’s integrated development and manufacturing network of 11 facilities and nine development centers, across North America and Europe, strives to ensure that customer products can be launched timely and confidently anywhere in the world.

    For information about the recorded archive for this event contact Xtalks at (416) 977-6555 ext 371, or email register@xtalks.com

     
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