Quality Control and Quality Assurance for Biotechnology Products
This course will cover in depth the key issues associated with adequate quality control systems, assays and stability for the novel biotechnology products.
The course will include class lectures and library research projects. Discussion of current reference articles and case studies will also be included.
Topics include:
- Definition of quality, Quality Control & Quality Assurance, Roles of QC/QA/RA
- QC Lot release testing - bioassays
- QC Lot release testing - chemical assays
- QC Assay validation; chemical/biochemical and bioassay
- QC Raw material testing, in-process testing, validation support
- QC Stability testing
- QC Microbiology (lot release, in process testing, validation support)
- QC Product characterization
- QC Monoclonal antibody products
- QC rDNA products
- QA Lot release, non-conforming material review, failure review
- QA Audit procedures and vendor certification
- Handling out-of-specification results
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
- Quality control/quality assurance professionals
Duration: 45 hours
Price: $1,195.00 (tuition is discounted to $1,145.00 if full payment is received three weeks from the start of the class)
Locations: Live Lecture at UMBC Main Campus, Video Transmission to NCI-Frederick Conference Center in Frederick, MD, and Distance Learning lectures downloaded online.
Date: August 28 , 2008 – December 11, 2008 (Thursday Evenings, 6:00 p.m. - 9:00 p.m.)
Click here to request additional information or to be added to the interest list for this course.