Document Detail


Introducing principles of validation into biochemistry and biotechnology courses: Practical concepts and a framework for active learning.
MedLine Citation:
PMID:  21591165     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
Although undergraduate biochemistry and biotechnology courses teach the concept of accuracy and precision during practical laboratory sessions, the formal teaching of validation methodologies receives little attention. An increasing number of biochemistry and biotechnology graduates are finding work in industry in the area of industrial validation associated with biopharmaceutical, diagnostics, biomedical device, and pharmaceutical validation. We have introduced a structured introduction to validation into our undergraduate industrial biochemistry programme to illustrate the importance of validation within a framework of good manufacturing practice (GMP) and to show how validation is essential for regulatory compliance.
Authors:
J T Pembroke
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Biochemistry and molecular biology education : a bimonthly publication of the International Union of Biochemistry and Molecular Biology     Volume:  36     ISSN:  1470-8175     ISO Abbreviation:  Biochem Mol Biol Educ     Publication Date:  2008 Jan 
Date Detail:
Created Date:  2011-05-18     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100970605     Medline TA:  Biochem Mol Biol Educ     Country:  United States    
Other Details:
Languages:  eng     Pagination:  70-5     Citation Subset:  -    
Copyright Information:
Copyright © 2008 International Union of Biochemistry and Molecular Biology, Inc.
Affiliation:
Industrial Biochemistry Programme, Molecular and Structural Biochemistry Laboratory, University of Limerick, Limerick, Ireland. tony.pembroke@ul.ie.
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