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December 2009

The Changing Face of Biobanks

Biobanking is changing rapidly, and it's in no small part due to the demands of systems biology. While small, university-centered banks have existed for decades, large-scale biobanks - whether tissue repositories or population databases - have recently been implemented all across the world. Many are also adding clinical annotation, genetic data, and increasingly genomic, proteomic, and other 'omics information. Population-wide biobanks exist in Iceland, the UK, Sweden, Canada, Estonia, Latvia, Singapore, and Japan. The UK Biobank is one of the most ambitious of these projects, intending to collect, store, and study the genetic information of 500,000 people with the hope of finding correlations between disease and lifestyle, environment, and genes. In the US, the Utah Population Database is the largest of these types of biobanks, housing data from generations of families for more than 8 million people.

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The 5 "W"s of Quality Agreements

Items to address in a Quality Agreement include all aspects of a project that affect the identity, quality, safety, potency, and purity of a product. Additionally, include aspects that may affect the compliance status of either the Contractor or Client. One of the most overlooked sections is the Definitions section - it is critical that everyone knows what is meant by every term used in the Quality Agreement; especially when contracting with non-U.S. parties, terminology can vary widely. Include abbreviations and acronyms, and define documents - one person's batch record is another person's data sheet. Define "subcontracting," and if/when it is acceptable. Also, what NOT to exclude from a Quality Agreement is also worth mentioning.

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Did you know that ASQ's recent Annual Salary Survey shows that quality professionals' average salary has risen despite recent economic setbacks? Why is it that quality professionals have "escaped" the jaws of an unpleasant economy? There are a variety of contributing factors but when all is said and done quality professionals with certifications and experience are coming out on top."
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