Articles

Mastering the Clinical Investigation“Mastering the Clinical Investigation,” published March 2010 in MD&DI Online. OEMs can benefit from the latest resources and current practices for clinical investigation programs.

 

How Companies Can Avoid Writing Dangerous DocumentsI wrote an article, “How Companies Can Avoid Writing Dangerous Documents,” that was published in the March/April 2009 issue of RAJ Devices.

See what else the press had to say about Dangerous Documents

Design Controls Are They Worth the EffortDavid 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.

Assessing the Cost of Poor QualityDan 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.

 

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

 

 

Empowering the Quality and Regulatory Compliance FunctionsGlenn 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.

 

 

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

 

 

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

 

 

FDA Industry Partnerships Moving toward More Equitable Enforcement“FDA/Industry Partnerships: Moving toward More Equitable Enforcement,” in the May 1999 issue of MD&DI Magazine.