Universal Technology Transfer Methodologies for Biopharmaceuticals:
June 14-15, 2010 Session

Date:  June 14-15, 2010
Time:  8:30 AM – 4:30 PM
Location:  Biomanufacturing Training and Education Center (BTEC), NC State University
Presented by:  Stephen M. Perry, PMP & Vladimir Kostyukovsky, PhD

Discover how to set-up a team of professionals essential for the success of tech transfer. Assess feasibility, business, and regulatory impact. Identify necessary actions and create detailed assay and process transfer plans. Monitor, evaluate progress, and manage proactively the ongoing technology transfer project. Define criteria and document success of the technology transfer. Defend the rationale for and the outcome of the transfer in front of US and international regulatory bodies.

Why Should You Attend?
Every time your organization is contemplating to move a process or product from one location (e.g. lab, manufacturing facility, country, etc.) to another, you enter the domain of technology transfer. The process is complex with multiple steps performed in a specific order, requiring significant resource commitments from many different groups in the organization for activities spanning from a few weeks to many months. All of this calls for comprehensive planning, effective coordination, and first-time-right execution, often on very aggressive timelines. By following the procedures and using the tools and templates provided, this course will allow you to avoid costly and often irreversible errors and to be successful, while being in control of schedule and budget.

Attend and You Will Learn
By the end of this course, students will be able to:

• Set-up a team of professionals essential for the success tech transfer
• Assess feasibility, business, and regulatory impact
• Identify necessary actions and create detailed assay and process transfer plans
• Monitor, evaluate progress, and manage proactively the ongoing technology transfer project
• Define criteria and document success of the technology transfer
• Defend the rationale for and the outcome of the transfer in front of US and international regulatory bodies

Who Should Attend?
Anyone involved in moving analytical assays and/or manufacturing processes internally or externally, in early development, for clinical or commercial manufacturing, including but not limited to professionals from the following functional areas:

• Process Development
• Manufacturing Sciences
• Quality Assurance and Regulatory
• Quality Control
• Manufacturing
• Validation
• Business Development
• Project Management

Attend and You Will Receive

• Four in-depth lectures on the specifics and mechanics of technology transfer
• Examples of real-life industry cases
• Detailed list of documents and tools required for technology transfer with samples and editable templates based on best industry practices
• Access to instructors with first-hand technology transfer experience
• Support of Kymanox capable staff for all of your technology transfer and technical project management needs

See the Course Description Page on Kymanox.com for more information.