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October 1, 2010

Effective Application of Quality-by-Design in Pharmaceutical Development and Product Manufacture

Keynote Speaker for this event:
  • Dr. Tahir Nazir,  Manager, Formulation Development, Pharmaceutical Development Services, Patheon UK Limited  Learn More
  • Introduction by: Norman Barras, Vice President, Pharmaceutical Development Services, Europe & Asia Pacific, Patheon UK Limited  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

    SPECIAL OPTION FOR ON DEMAND VIEWERS

    Sign up for a 15 minute private session with Patheon to discuss your individual needs and challenges.

    For more information and to register for the On Demand Archive contact Xtalks at (416) 977-6555 ext 371, or email register@xtalks.com

    ABOUT OUR SPEAKER:

    Dr. Tahir Nazir,  Manager, Formulation Development, Pharmaceutical Development Services, Patheon UK Limited  

    Dr Tahir Nazir is a formulation scientist with more than 20 years experience in the pharmaceutical industry and academia. During this time Tahir has worked for biotech companies, contract research organisations and academic institutions. He has been involved in the development of many different products and dosage forms. In recent years, Tahir has specialised in the development of paediatric and topical products. In his current role at Patheon, as Manager of the Formulation Department, Tahir leads a team of pharmaceutical formulation scientists developing non-sterile and sterile products for many different clients from the pharmaceutical and biotech industries. Tahir did his academic training at Cardiff University (UWIST), completing his Bachelor in Industrial Chemistry; his Masters in Pharmaceutical Analysis and Ph.D. in Pharmaceutics at King’s College London.

    Norman Barras, Vice President, Pharmaceutical Development Services, Europe & Asia Pacific, Patheon UK Limited

    Mr. Barras joined Patheon in 2005 as Group Director, PDS Swindon, bringing more than 24 years of experience to his role, and was appointed to his current position in April 2006. Prior to Patheon, he served for 13 years in a number of senior roles at U.K. specialty company Norgine International Ltd., including Medical Director, Scientific Director, and Vice-President of R&D. His career also includes positions with the Upjohn Company, Controlled Therapeutics and PA Consulting Group. He holds a Bachelor of Science (Hons.) in Chemistry from Paisley University and a Master of Science in Biochemical Pharmacology from the University of Hertfordshire.

    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.

     
     
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