BTEC 3340
Quality Assurance and
Regulatory Issues in Biotechnology
Fall
2008
Instructor: J. D. Hendrix
Last
Updated: Nov 9, 2008
Link
to Microbiology ppt has been added
Presentation
Assignments
Sept 8: FDA (Bornholm, Jenkins & Waters); USDA
(Dillard, Lowery & Thomas)
Sept 10: EPA (Hasham, Esha
Patel & Unnati Patel); OSHA (Akinjobi,
Beard & Roper)
Sept 15: GMP (Gallango-Brun, Khan & Sahovic); GLP (Ford, Gladney
& Osakwe)
Sept 17: GCP (Jain & Traver); HACCP (Desai & Restrepo)
Please send a copy of your PowerPoint to the professor
via email attachment on or before the day of your presentation.
Presentation Grading: 50 points total
|
Appropriate Breadth |
20 |
|
Quality of the PowerPoint |
10 |
|
Quality of the Verbal Presentation |
10 |
|
Peer Review |
5 |
|
Participation Grade |
5 |
Any student who is absent, late, or leaves early
during a presentation day will automatically lose all of the participation
grade points.
Presentation Powerpoints
FDA
USDA
EPA
OSHA
GMP
GLP
GCP
HACCP
Microbiology
Biosafety Levels
Environmental
Monitoring
Safety Cabinets
& Fume Hoods
Autoclaves
Balances and
Micropipettes
Reagent
Quality
Standard Operating
Procedures
Recordkeeping
Links
http://www.fda.gov/opacom/backgrounders/miles.html
http://eh.net/encyclopedia/article/Law.Food.and.Drug.Regulation
http://www.spartacus.schoolnet.co.uk/Jupton.htm
http://www.macbicnj.com/chemicals.htm
http://www.jtbaker.com/catalog/features/inside_cat_grade.html
http://jchemed.chem.wisc.edu/JCESoft/CCA/CCA6/MAIN/HOME.HTM
http://www.wooster.edu/chemistry/is/brubaker/ph/ph_landmark.html
http://www.fhcrc.org/labs/hahn/methods/biochem_meth/biorad_assay.pdf
http://www.cfsan.fda.gov/~ebam/bam-toc.html
Links
to "Measurements" sites
http://antoine.frostburg.edu/chem/senese/101/measurement/
http://wind.cc.whecn.edu/~mechalke/chapter2/Lecture_Ch2.htm
Utilities
Free
viewers for Word documents and PowerPoint presentations are available at http://www.microsoft.com/
Free viewers for Adobe Acrobat (.pdf) files are
available at http://www.adobe.com/
A license-free office suite, compatible with Microsoft office, is available
at http://www.openoffice.org/
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