October 2013

For Blood & Biologics Companies

Innovation and the Quality Process

by Ken Peterson, MasterControl Inc.

Thinking of new ideas and putting those ideas to practical economic use can be more of an art than a science. At times innovation sends a signal that is in opposition to quality. If we are constantly trying to solve problems and find solutions through effective investigation of failures, do we ever consider that the best solution is to ignore the past and invent the future?

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Elements of Successful Quality Agreements

by Steven Sharf, GMP Concepts

Many GxP professionals are already familiar with the expectation of FDA and the requirement in the EU to have quality agreements with third parties and suppliers. Throughout this article, I will define what a quality agreement is, when one is needed, the 24 basics that factor into this critical document, and some things to avoid when drafting one. Finally, I will discuss alternate means of communicating quality expectations when a supplier will not agree to enter into a full quality agreement.

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Disaster Recovery and Validation

by Louis Rutledge, MasterControl Inc.

Disaster! Today’s business world shudders at the word. With the current random occurrences of hurricanes, super storms, earthquakes, blizzards, fires, flooding and sustained power outages, it is a wonder how companies can recover to survive all of the natural or modern threats to their daily business operations and collection of business data. Today’s business world is dependent on the data created and stored for many aspects of daily operations: financial data; product specifications; designs; testing records; and quality management systems (QMS) data are only a few examples. How can you protect your precious data in the face of all these threats?

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Advances in Saving Lives with Blood

by FDA's Consumer Updates

An FDA official in the Office of Blood Research and Review discusses promising technologies involving blood and blood products, from extending the life of blood products to using DNA technology to better match donors and recipients.

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