Technology Transfer: Focus on the Business Process and Practical Execution (E07)

24-25 February
CEUs: 1.2
Intermediate/Advanced
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Current as of 15 February 2010
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It is easy to underestimate the effort required for effective technology transfer. As more companies look to outsource manufacturing operations across the globe, the timeliness and value of getting it right is crucial. Technology transfer is more than just the transfer of a product and/or a manufacturing process. It is a key tool in a company’s strategic operation that must be understood in order to effectively manage. It is difficult, in part, because it continues to be underestimated.

This seminar provides an interactive workshop focused on the execution and management of technology transfer, both from a business process and technical standpoint. It looks at tools and approaches that foster success. Using the ISPE Good Practice Guide: Technology Transfer as a reference tool, subject matter experts will address:

  • Structuring an approach to the business process of technology transfer
  • Formation of a team
  • Establishment of good communication tools
  • Setting objectives and acceptance criteria
  • Good documentation
  • Knowledge transfer across companies, continents, and cultures
  • Analytical methods transfer
  • Regulatory compliance; understanding the regulatory environment

The use of a case study scenario as the platform for a series of interactive group workshop activities will bring a real world element to this seminar, and challenges attendees to consider both the business process and technical aspects at the same time.

Free Technology Transfer Webinar for Attendees

The Technology Transfer webinar on 2 February will provide Tampa Conference seminar attendees with important information related to the foundation principles of Technology Transfer and key elements and success factors that are foundational. Visit www.ispe.org/technologytransferintro for details and registration.

How You Will Benefit

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

  • Understand critical elements of technology transfer
  • Define goals and objectives that relate to the project objective
  • Identify critical business process elements
  • Develop a successful team
  • Develop effective communication tools
  • Understand the critical elements of knowledge transfer
  • Identify key regulatory issues
  • Develop effective documentation
  • Address key business management challenges in technology transfer
  • Pull all of the above into an effective technology transfer program

Who Should Attend

Development engineers, process engineers, project managers, quality assurance and quality control personnel, validation specialists, technology services managers, process/development chemists, and production managers

Leaders

Speakers

    Communities of Practice (COPs)

    Process/Product Development

    www.ISPE.org/COPs

    CPIP™ Knowledge Elements

    This Webinar relates to the following CPIP™ Knowledge Elements:

    • 1. Product Development
      • A. Formulation, clinical phases, and manufacture
      • B. Technology transfer
      • C. Production scale-up and optimization
    • 5. Production Systems
      • A. Production unit operations - drug (small molecule) and biologics
      • B. Production management
      • C. Production control
    • 6. Regulatory Compliance (Drugs, Env., Health, and Safety)
      • A. Government regulations
      • B. Standards, practices, and guides
    • 7. Quality Systems
      • B. Systems validation

    More information on CPIP

    Related Technical Documents, Articles, and Publications

    ISPE Good Practice Guide: Technology Transfer

    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.

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