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2009 New Brunswick Course Series

Register Now

Location: New Brunswick, NJ, USA
Date: October 19-21, 2009
Time: All courses run 8:30 a.m.-4:00 p.m. unless otherwise noted.

Early registration discounts available! Register by September 9, 2009 and save $100 on a one-day course or $200 on a two or three-day course. This offer only applies to the member and nonmember rates and cannot be applied in addition to group rate discounts. Please register by fax or mail to receive this discount rate.

Available Courses:

  • Design of Experiments for Efficient and Practical Assay Development and Validation
    October 19, 2009
    This course covers design of experiments (DOE as used for development and validation of assays. The DOE topics covered will include factorial and fractional factorial designs, response surface designs, as well as nested and split-unit designs.

  • Assessing Packaging and Processing Extractables/Leachables
    October 19-20, 2009
    This lecture and discussion based course will review guidances and other regulations regarding the reporting, identification, measurement, and toxicological qualification of extractables/leachables from packaging materials into pharmaceutical products. A detailed discussion of the sources of extractables from packaging materials, such as plastic, glass and rubber, will be included. Extractables from both packaging and processing materials will be discussed. This course will provide the attendee with a synopsis of the current regulations and provide a means to deal with the issues in a responsible, scientific and cost-effective manner.

  • Fundamentals of Lyophilization
    October 19-20, 2009
    This course is designed for participants to develop an understanding of the basic principles and practical aspects of lyophilization technology.

  • Pharmaceutical Water Systems Design and Validation
    October 19-21, 2009
    This course is structured to address the design, operation, maintenance, microbiology and validation of pharmaceutical water systems.

  • Root Cause Investigation for CAPA
    October 20-21
    This course utilizes a template to guide the participants through the CAPA investigation and suggest appropriate tools.

  • Quality and Regulatory Requirements and Development Strategy for Pre-filled Syringes, Pre-filled Dru
    October 21, 2009
    This course will provide a discussion, review and interpretation of relevant laws, regulations and guidance for best practices for the design, development, manufacture, testing registration and marketing of Combination Products in the US and Borderline Products in Europe. The program also focuses on solving practical quality, regulatory problems and development problems involving drug prefilled delivery devices.

  • Applied Quality Systems
    October 21, 2009
    New Brunswick, NJ, This course is designed to assist the participants in applying systems thinking to their quality program. Most compliance problems occur as a result of poor integration within and between processes.

  • Contact
    Stephanie Ko
    PDA Training and Research Institute
    Manager, Lecture Education
    Tel: +1 (301) 656-5900 ext. 151
    Email: ko@pda.org

  • Location/Lodging Information
    THE HELDRICH
    10 Livingston Avenue
    New Brunswick, NJ 08901
    +1 (732) 729-4670

    Rate
    $175 Single/Double
    Cut-Off Date: September 25, 2009

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