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David Jones, the quality assurance director in the Regulatory Affairs and Philips Business Excellence division of Philips Consumer Healthcare Solutions and I were interviewed by Erik Swain of MD&DI on "Design Controls: Are They Worth the Effort?" in the October 2007 issue of MD&DI Magazine.

Dan Olivier of Certified Compliance Solutions and I wrote an article on Assessing the Cost of Poor Quality  in the June 2007 issue of MD&DI Magazine.

Marlene Bobka and I wrote an article, “Freedom of Information Act Requests: A Primer" in the February 2007 issue of MD&DI Magazine.

Glenn George of QRC Associates, Ken Imler of Arrow International and I wrote on "Empowering the Quality and Regulatory Compliance Functions"  in the January 2007 issue of MD&DI Magazine.

Fran Akelewicz and I have an article on "Corrections and Removals: To Tell or Not to Tell" in the April 2006 issue of MD&DI.

Richard DeRiso of KCI and I were interviewed by Erik Swain about complaint handling practices in the May issue of MDDI magazine.

Fran Akelewicz and I have an article on corrections and removals in the April 2006 issue of MD&DI.

Richard DeRisio and I wrote an article “Optimizing Regulatory Compliance: Nine Strategies for Success” in the August 2005 edition of MD&DI.

Other articles -
The Progress and Potential of FDA Inspections

FDA/Industry Partnerships: Moving toward More Equitable Enforcement