Master of Science in Biotechnology Program, UW-Madison

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Course Descriptions

Biotechnology Operations

Instructors:

  • Ed Elder, Ph.D., R.Ph.
  • Dave Bormett, M.S.
  • Jay Schiestle, M.B.A.
  • To succeed, biotechnology companies must juggle a host of complex technological and managerial functions.

    This course takes a close-up look at seven interdependent functional specialties key to developing products for human health: regulatory affairs, quality assurance, biomanufacturing, quality control, non-clinical development, clinical development and project management.

    You'll understand how companies plan, manage, coordinate and synchronize these disciplines to support a specific marketing plan—and how the underlying principals and practices are relevant to product development in other areas of biotechnology.

    You'll also learn how to design a development strategy, communicate objectives and lead a team through implementation.

    Here are some of the topics taught in this course:

    Session Topics from Spring 2016

    Session 1: Course Introduction; Overviews of Product Development; Project Management; Quality Systems – Introduction, Quality by Design, Risk Management; and Hallmarks of Quality Systems

    Session 2: Quality Control — Specifications and Procedures; and Chemistry, Manufacturing, and Controls Introduction and Overview; From CMC to BioManufacturing

    Session 3: Application of Quality Systems; BioManufacturing — Facilities, Equipment, and Utilities; and Overview of Regulatory Affairs — Roles and Responsibilities, Meeting with Agencies, Regulatory Submissions

    Session 4: BioManufacturing — Process Design, Fermentation and Cell Culture; and Clinical Development – Clinical Research, Clinical Operations, and Good Clinical Practice

    Session 5: BioManufacturing — Concentration and Purification, Aseptic Processing and Sterilization; and Introduction to Nonclinical Research — Pharmacology, Toxicology, Pharmacokinetics and Good Laboratory Practice

    Session 6: BioManufacturing — Overview of Validation; Managing Non-FDA Compliance; Class Lectures – Current Issues in Biotechnology; Team Presentation Workshop

    Session 7: Phase I Clinical Study Design and Implementation – A Case Study; Final Team Project Presentations (Location: MG&E, Conference Room 50)

    Question about the degree?
    Contact Bryan

    Bryan Husk
    Assistant Director
    Phone: (608) 265-0773
    bthusk@wisc.edu
    Contact Bryan Husk, Assistant Director, M.S. in Biotechnology Program, UW-Madison
    Class of 2018 Schedule

    Fall 2016 | Spring 2017
    Fall 2017 | Spring 2018

    Class of 2019 Schedule

    Fall 2017 | Spring 2018
    Fall 2018 | Spring 2019

    Class of 2020 Schedule

    Fall 2018 | Spring 2018
    Fall 2019 | Spring 2020