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Design, Construction, and Validation of GMP Biotechnology Facilities

  

Course Description | Instructor Information | Biotech Home

Overview

This course presents a detailed discussion of the design, construction, and validation issues to be considered for a GMP Biotechnology Manufacturing facility. Topics to be covered include architectural considerations, equipment, utilities, materials of construction and computerization. The latest information on FDA expectations will be presented. Implications for the smaller biotech manufacturer will be specifically addressed.

The course will include class lectures and short research projects. Discussion of current reference articles and case studies will also be included. A final exam and project papers will be required for credit students.

Lecture Topics

  • Overview/Project Life Cycle/Master Plan
  • Bulk Plant Design from a Process/Product Perspective
  • Bioreactor/Downstream Equipment Design
  • Facilities Design Overview/Architectural Considerations
  • Utilities/Materials of Construction: Properties and Selection
  • SIP/CIP
  • HVAC/Sterile Piping
  • Containment/Safety
  • Instrument Controls/Software Validation
  • Computerization/CIM/POM
  • Facilities/Utilities Validation
  • Approaches for the smaller biotech manufacturer
  • Contractual considerations
  • Licensing
  • FDA perspective

Who should attend

  • Biotechnology professionals/biochemical engineers
  • Industrial and government researchers
  • Faculty and graduate students (engineering, chemistry, biology and pharmacy)
  • Entrepreneurs, lawyers, patent attorneys with interest in biotechnology
  • Architects and engineers
  • Regulatory affairs professionals

Duration: 45 hours

Price: $1,195.00

Tuition includes instructor-led lecture and course materials

Locations: Live lecture at the UMBC main campus, video transmission to NCI-Frederick Scientific Library in Frederick, MD and online via a distance learning option (lectures will be posted online within 24 hours of class - lectures are not streamed live).

Session Dates
Session Time
Location
Register for Session
Janaury 29 – May 7, 2009
Thursday Evenings
6:00 p.m. - 9:00 p.m.
UMBC
Ft. Detrick/Frederick
.
Distance Learning
Option

  • A distance learning option for this course is also available. Please e-mail info@umbctrainingcenters.com for additional information.
  • Click here to download and complete the registration form to mail in or fax
  • Click here to request additional information or to be added to the interest list for this course.