Aseptic Processing of Sterile Products: Innovations, Regulatory Guidance and Compliance in a Practical World (E01)

21-22 February
CEUs: 1.2

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Course Level is Intermediate to Advanced

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Planned and Implemented by the ISPE Sterile Products Processing Community of Practice (COP)

Attend this two-day seminar to learn about the latest commercially proven solutions in aseptic processing which you can apply.

  • Get updates on hot regulatory topics
  • Learn from experts working in similar environments to yours
  • Participate in in-depth case study presentations and discussions
  • Network with attendees and presenters

Topics will cover a range of technologies for sterile products, from compounding to inspection and include:

  • Sterile filtration
  • New filling equipment
  • Contract manufacturing capabilities
  • Lyophilization technology challenges
  • Visual inspection technologies
  • Recent warning letters / regulatory updates
  • Case studies

This session will also feature the new ISPE Baseline® Guide: Sterile Manufacturing Facilities*.

How You Will Benefit

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

  • Describe what is happening in the world of sterile technologies
  • Evaluate warning letter implications for their business
  • Apply learning from others through case study
  • Explain recent regulatory trends
  • Expand your industry network

Who Should Attend

Professionals from engineering, operations, quality, planning and project management

Leaders

Speakers

    This Session relates to the following Communities of Practice (COPs)

    Sterile Products Processing

    www.ISPE.org/COPs

    Related Guidance Documents, Articles, and Publications

    • NEW - ISPE Baseline® Guide: Sterile Manufacturing Facilities*
    • Recent Warning Letters

    Visit www.ISPE.org/Publications for more information


    *Anticipated release date Q1 2011. Date is subject to change. This seminar is priced to include an electronic copy of the guide.

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