FDA INVESTIGATOR GIVES SPEECH ON QUALITY TO THE DRUG INDUSTRY

    /24-7PressRelease/ - RALEIGH, NC, October 15, 2007 - The Drug Quality Association held its annual conference in the Research Triangle Park in Raleigh, NC and discussed common quality deficiencies within the pharmaceutical industry.

FDA Investigator DeVaughn Edwards spoke with the Drug Quality Association regarding the industry's current compliance deficiencies. Mr. Edwards was the keynote speaker and fielded questions from the audience as to the Agency's most common observations. During his speech, Mr. Edwards pointed out that "common deficiencies are frequently rooted in the complacency of industry managers. They assume that because problems have not been uncovered during an inspection, they don't exist. This can be a dangerous assumption." Mr. Edwards is a 14-year veteran with the Food and Drug Administration and has led inspections in over 18 countries. He works with the FDA Atlanta District. Comments after the meeting included participant Jessica Davis' comment "Mr. Edwards gave very helpful insight on problems the FDA finds most commonly - issues we'll be sure to review and control."

Other speaker topics included "Approaches to CAPA" (Corrective and Preventive Actions) and "FDA Initiatives - Q10 and P.A.T." The conference concluded with an awards presentation including a Certificate of Appreciation presented to Mr. Edwards. Further information can be obtained at www.fda-approved.net

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