Design, Construction and Validation of GMP Biotechnology Facilities
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.
Topics include:
- 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 UMBC Main Campus, Video Transmission to The Universities at Shady Grove in Rockville, MD, Video Transmission to NCI-Frederick Scientific Library in Frederick, MD
A distance learning option for this course is also available. Please e-mail info@umbctrainingcenters.com for additional information.
Click here to request additional information or to be added to the interest list for this course.