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FDA Investigator Gives Speech On Quality To Drug Industry

FDA Investigator Tells Drug Industry Not To Make Assumptions From Inspection Observations

FOR IMMEDIATE RELEASE

PRLog (Press Release) - Oct 06, 2007 -
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 commonly 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.”  Mr. Edwards was presented with a certificate of appreciation at the conclusion of the seminar.

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Source:Samuel Harris
Industry:Biotech, Pharmaceutical
Tags:, , , , , , , , , cfr 211
Shortcut:http://prlog.org/10033335
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