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(9 classifications) (12 resources)

Quality, Regulations, and Standards

Topic
FDA organization (3)
FDA regulations (cGMP, GLP, GCP) (3)
General principles (5)
ISO and ISO 9000 (1)
Quality assurance (3)
Quality control (2)
Regulatory history (1)
Regulatory process for medical devices (2)
Regulatory process for pharmaceuticals (3)

Resources
View Resource Pharmaceutical Regulation in the United States: History and a Case Study

Drugs are regulated in the United States by the FDA. This exercise reviews the history of some FDA regulations. The Case Study describes the impact one FDA official had by stopping a dangerous drug from coming on the market in the US. A classroom discussion underscores the importance of regulating new drugs.

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http://www.bio-link.org/GMP/KELPOST.html
View Resource Biotechnology Books

Annotated bibliography of useful books related to biotechnology. This project was started by Jim Dekloe; although the list has not been updated since 2003, it is still useful. The topics covered here include general biotechnology books, bioinformatics and genome projects, immunology, food biochemistry, and many more. Bio-Link staff are currently revising this document (2010).

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http://www.bio-link.org/GMP/Reviews.htm
View Resource BioPortal Canada

Canada is fast becoming a biotechnology hub, and the Canadian government has created this site as a clearinghouse of information both about biotechnology in general and about the various governmental strategies they have adopted in order to encourage development in this area. The materials on the site are divided into five sections: "BioGateway", "BioBasics", "BioStrategy", "BioRegulations", and...

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http://bioportal.gc.ca/english/BioPortalhome.asp
View Resource Biotechnology Safety Curricula

This site from the University of Nebraska, Lincoln, contains curricula and synopsis of the safety assessment and regulatory processes for plant products. Visitors will find five lesson plans: Student Created Survey on Genetically Engineered Crop Safety Issues, Case Study on Bt Corn Pollen and The Monarch Butterfly, Designing a System to Ensure GE Agiculuture Safety, Student Debate on the Risk of...

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http://agbiosafety.unl.edu/safety.shtml
View Resource The Microbiology Network

The Microbiology Network is a free service sponsored by several microbiology companies with the objective of providing a communication resource for microbiology and biotechnology professionals. Their mission is to improve of regulatory science and compliance and compliance in the area of microbiology. Although the site is free, the network also provides access to consultation services,...

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http://www.microbiol.org/
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