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December 2009

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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Beyond the Basics - Building Business Value through an Effective Compliance Program

Through the recent overhaul of the AdvaMed Code of Ethics, medical device companies gained the opportunity to use the renewed emphasis on ethics to revamp their approach to compliance. Most companies quickly integrated the updated Code provisions into their compliance policies and trained their employees to follow explicit guidelines about appropriate and inappropriate interactions and arrangements with healthcare professionals. Now they stand ready to take the next steps to build global compliance programs that create business advantage, foster innovation, and contribute to long-term viability.

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Please Don't Call Them CAPAs

I've long been troubled by the ubiquitous acronym used to refer to corrective action: CAPA. My gut reaction borders on the irrational. Most of you reading this have heard of or read about or used the acronym hundreds of times. And you're probably wondering why the two syllables CA-PA should produce such an extreme reaction - especially in someone who spends a great deal of her time teaching people about both corrective action and preventive action. The short answer is simple: They're two separate processes that have been mashed together resulting in a diminution in the effectiveness of both.

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MD&M West 2010
February 9-11, 2010, Anaheim, CA

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March 3-4, 2010, Washington DC

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June 7-10, 2010, New York, NY

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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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