Oral Solid Dosage: New Guidance You Can Use Right Now (E03)

22-23 February
CEUs: 1.2
Intermediate/Advanced
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Current as of 27 January 2010
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This is sponsored by the OSD Community of Practice.

Examine and extract critical perspectives from warning letters and apply the new industry guidance to the benefit of your company. Attend this session covering the key topics of risk assessment, adulteration, compliance-focused processes, as well as other key topics vital for multi-product production and development. This session will feature the entirely new, ISPE Baseline Guide: Volume 2 – Oral Solid Dosage Forms, which has been reviewed by the FDA. Issues identified in warning letters will be used as the basis for problem-solving workshops and discussions with subject matter experts. An FDA speaker has been invited and the two-day seminar will be lead by members of the Guide Writing Team.

Breakout sessions using the new OSD Guide will allow you to discuss solutions to real problems faced in an OSD environment with subject matter experts. An FDA speaker has been invited, and the seminar will be lead by members of the OSD Guide writing team. An OSD Guide copy will be provided as part of seminar registration.

How You Will Benefit

At the conclusion of this session, participants will be able to:

  • Understand the importance of the new guide
  • Understand how it can help you avoid compliance issues
  • Be able to incorporate its elements to improve quality, efficiency and reduce costs

Who Should Attend

Anyone involved in OSD manufacturing and especially those in Generic and Contract Manufacturing since you are currently a focus of FDA and other Global Regulatory agencies

Leaders

Speakers

    Communities of Practice (COPs)

    Oral Solid Dosage

    www.ISPE.org/COPs

    CPIP™ Knowledge Elements

    This Webinar relates to the following CPIP™ Knowledge Elements:

    • 2. Process, Equipment and Facilities
      • A. Design and construction/installation
      • B. Commissioning and qualification as a risk management strategy
    • 6. Regulatory compliance (includes drugs, environmental, health and safety)
      • B. Standards, practices, and guides
    • 7. Quality Systems
      • A. Quality Risk Management(QRM)
      • B. Quality Management System (QMS)

    More information on CPIP

    Related Technical Documents, Articles, and Publications

    ISPE Baseline Guide®: Volume 2 – Oral Solid Dosage Forms (Second Edition) (Available November 2009)

    www.ispe.org/publications

    Continuing Education Units 

    ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.

    Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.

    Event Sponsors