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


Syllabus


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
and Depth of Coverage

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.fda.gov

http://www.fda.com

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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