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UF offers Core Concepts in Biomanufacturing and Quality Systems: Designed for the development of skills required for success in today’s biotechnology industry, this course covers two tracks: “Processes & Facilities” and “Regulatory Affairs, Quality Assurance, & Quality Control.” Using a blend of hands-on applications and lectures, course instructors integrate core concepts of processes and facilities with quality compliance to build a solid understanding of the development, manufacture, testing, and release-for-sale of a regulated product. Students will be asked to apply project management skills in the production and regulation of a standard biotechnology-based process. Topics covered include:

Processes & Facilities

  • Manufacturing
  • Equipment (Maintenance, Calibration)
  • Raw Material (Sourcing, Storage)
  • Aseptic Processing
  • Building Systems

Regulatory Affairs, QA, & QC

  • cGMP’s, cGLP’s, cGCP’s
  • FDA Organization Structure (Overview)
  • Regulatory Compliance
  • Documentation
  • Validation, Sampling, & Testing Methods

Each student will complete both tracks of study. An industry recognized certificate documenting 24 hours of blended hands-on experience and lecture, will be issued upon completion.

Who should attend: This course is intended for current employees in biotechnology, or individuals who are interested in entering a career in the biotechnology industry.

  • Employees of Start-up Companies – Build a culture of quality from the start!
  • Employees of Established Companies – Documented Training and Professional Development!
  • Scientists Transitioning from Academic Research to Industry
  • Students or individuals interested in employment in the Biotechnology Industry Sector

Course Time and Location
DATES: June 4-7th, 2012

TIME: June 4th & 6th 1:00 – 5:00 p.m. June 5th & 7th 9:00 – 5:00 p.m.

LOCATION: UF’s Center of Excellence for Regenerative Health Biotechnology Education Center, 13706 Innovation Drive, Alachua FL, Education Center (Lab 204)

Through funding from the Banner Center for Life Sciences, we are offering a reduced rate of $125! Call for assistance with overnight accommodations

Registration Deadline: May 31st, 2012

Click Here to Register: http://www.cerhb.ufl.edu/education-center/register/register.aspx

For more information or any questions, contact Lori Wojciechowski: 386.462.3181, lwojo@ufl.edu, or log on to our web site: http://www.cerhb.ufl.edu/education-center

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