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	<title>JE Hamilton &#38; Associates</title>
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	<link>http://www.jehassociates.com</link>
	<description>Compliance solutions that improve the quality of life ®</description>
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		<title>Substandard Drugs and the Fight Against Tuberculosis</title>
		<link>http://www.jehassociates.com/2013/04/substandard-drugs-and-the-fight-against-tuberculosis/</link>
		<comments>http://www.jehassociates.com/2013/04/substandard-drugs-and-the-fight-against-tuberculosis/#comments</comments>
		<pubDate>Sat, 20 Apr 2013 05:42:42 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Compliance]]></category>
		<category><![CDATA[Manufacturing]]></category>
		<category><![CDATA[Quality]]></category>
		<category><![CDATA[Regulatory]]></category>

		<guid isPermaLink="false">http://www.jehassociates.com/?p=5607</guid>
		<description><![CDATA[Health Affairs is a peer-reviewed journal  founded in 1981 under the aegis of Project HOPE, a nonprofit international health education organization. They recently published a blog addressing substandard drugs and the fight against TB: Health Affairs Blog: By: Agnes Binagwaho Roger Bate: April 15, 2013 Poorly manufactured and fraudulent medicines kill thousands of people around the world each year. For [...]]]></description>
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		<title>Big Pharma&#8217;s Quality by Design (QbD) Approach to Clinical Trial Management</title>
		<link>http://www.jehassociates.com/2013/04/big-pharmas-quality-by-design-qbd-approach-to-clinical-trial-management/</link>
		<comments>http://www.jehassociates.com/2013/04/big-pharmas-quality-by-design-qbd-approach-to-clinical-trial-management/#comments</comments>
		<pubDate>Tue, 16 Apr 2013 00:00:06 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Clinical Trials]]></category>
		<category><![CDATA[Compliance]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Quality]]></category>
		<category><![CDATA[Regulatory]]></category>

		<guid isPermaLink="false">http://www.jehassociates.com/?p=5593</guid>
		<description><![CDATA[A recently published article in Pharmaceutical Executive discusses big pharma&#8217;s Quality by Design (QbD) approach to clinical trial management. By: Pharmaceutical Executive April 1, 2013 Improving the quality of clinical trials has emerged as a major strategic activity for Big Pharma, one where efficient management of a demanding set of regulatory requirements—not to mention mounting clinical and [...]]]></description>
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		<title>Consulting Magazine Celebrates: The Profession&#8217;s Best Small Firms</title>
		<link>http://www.jehassociates.com/2013/04/consulting-magazine-celebrates-the-professions-best-small-firms/</link>
		<comments>http://www.jehassociates.com/2013/04/consulting-magazine-celebrates-the-professions-best-small-firms/#comments</comments>
		<pubDate>Sat, 06 Apr 2013 09:02:40 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Consulting]]></category>

		<guid isPermaLink="false">http://www.jehassociates.com/?p=5517</guid>
		<description><![CDATA[On Thursday, April 18 at the W Chicago City Center, Consulting Magazine will host an Awards Dinner to honor the very best small consulting firms. It truly is a remarkable achievement for these firms to be recognized and we wish to offer our congratulations. Consulting Magazine Consulting Magazine Achievement Awards: The Profession’s Best Small Firms On [...]]]></description>
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		<slash:comments>0</slash:comments>
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		<title>Medical Device Quality Initiatives</title>
		<link>http://www.jehassociates.com/2013/04/medical-device-quality-initiatives-grow-the-carrot-chop-the-tree/</link>
		<comments>http://www.jehassociates.com/2013/04/medical-device-quality-initiatives-grow-the-carrot-chop-the-tree/#comments</comments>
		<pubDate>Tue, 02 Apr 2013 22:19:17 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Compliance]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Manufacturing]]></category>
		<category><![CDATA[Quality]]></category>

		<guid isPermaLink="false">http://www.jehassociates.com/?p=5463</guid>
		<description><![CDATA[A post on medical device quality by Michael Causey, citing a new report from Booz &#38; Company. Assurx Blog MARCH 26, 2013 Medical Device Quality Initiatives: Grow the Carrot, Chop the Tree The giant sequoia trees in the Pacific Coast are breath-taking. Majestic and seemingly indestructible, they stand tall as a reminder that slow and steady sometimes [...]]]></description>
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		<title>FDA inspects specialty compounding pharmacies in targeted action</title>
		<link>http://www.jehassociates.com/2013/03/fda-inspects-specialty-compounding-pharmacies-in-targeted-action/</link>
		<comments>http://www.jehassociates.com/2013/03/fda-inspects-specialty-compounding-pharmacies-in-targeted-action/#comments</comments>
		<pubDate>Mon, 04 Mar 2013 22:38:33 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Compliance]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Manufacturing]]></category>
		<category><![CDATA[Quality]]></category>

		<guid isPermaLink="false">http://www.jehassociates.com/?p=5223</guid>
		<description><![CDATA[The Washington Post Published: March 1 By Lena H. Sun and Kimberly Kindy In response to pressure from Congress and health-care watchdogs, federal regulators have launched an aggressive surprise inspection campaign of large specialty pharmacies, in the spotlight after a deadly meningitis outbreak last fall that was linked to tainted drugs, officials said Friday. Inspectors [...]]]></description>
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		<title>Ensuring Drug Quality in Global Health Programs</title>
		<link>http://www.jehassociates.com/2012/08/ensuring-drug-quality-in-global-health-programs/</link>
		<comments>http://www.jehassociates.com/2012/08/ensuring-drug-quality-in-global-health-programs/#comments</comments>
		<pubDate>Wed, 01 Aug 2012 23:25:47 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Quality]]></category>

		<guid isPermaLink="false">http://www.jehassociates.com/?p=4790</guid>
		<description><![CDATA[By: US GAO U.S.-funded global health programs have put regulatory and policy requirements in place to help prevent procurement of substandard drugs. USAID, for example, reviews quality assurance information for all drugs before they are procured. Specifically, USAID requires implementing partners to obtain written approval from the agency before purchasing drugs. Through its approval process, [...]]]></description>
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		<title>Doing Business in China &#8211; Considerations for Effectively Leveraging Emerging Markets</title>
		<link>http://www.jehassociates.com/2012/08/doing-business-in-china-considerations-for-effectively-leveraging-emerging-markets/</link>
		<comments>http://www.jehassociates.com/2012/08/doing-business-in-china-considerations-for-effectively-leveraging-emerging-markets/#comments</comments>
		<pubDate>Wed, 01 Aug 2012 22:56:41 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Compliance]]></category>
		<category><![CDATA[Quality]]></category>

		<guid isPermaLink="false">http://www.jehassociates.com/?p=4788</guid>
		<description><![CDATA[By Bikash Chatterjee and Chat Kwan, Pharmatech Associates PharmPro.com The U.S. economic slowdown and the Eurozone debt crisis have created pressure in the pharma industry that shows no signs of relenting. Yet, with the global pharma market forecasted to languish in single digit growth, emerging markets such as Brazil, China, India, Mexico, Russia and Turkey [...]]]></description>
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		<title>Concerns Over Quality Of Imported Drugs</title>
		<link>http://www.jehassociates.com/2012/07/concerns-over-quality-of-imported-drugs/</link>
		<comments>http://www.jehassociates.com/2012/07/concerns-over-quality-of-imported-drugs/#comments</comments>
		<pubDate>Sun, 29 Jul 2012 22:01:57 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Quality]]></category>

		<guid isPermaLink="false">http://www.jehassociates.com/?p=4449</guid>
		<description><![CDATA[By: Chrishanthi Christopher: The Sunday Leader Last week the State Pharmaceutical Corporation (SPC) and the private pharmaceutical drug importers were at logger heads over the low quality pharmaceutical drugs flooding the local market. This comes in the wake of the Sri Lanka Medical Practitioners Association calling for a quality assurance lab to test all imported drugs claiming [...]]]></description>
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		<title>2012 Top 10 FDA Red Flags</title>
		<link>http://www.jehassociates.com/2012/07/2012-top-10-fda-red-flags/</link>
		<comments>http://www.jehassociates.com/2012/07/2012-top-10-fda-red-flags/#comments</comments>
		<pubDate>Wed, 11 Jul 2012 04:09:38 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Manufacturing]]></category>
		<category><![CDATA[Quality]]></category>

		<guid isPermaLink="false">http://www.jehassociates.com/?p=4263</guid>
		<description><![CDATA[By: Eric Palmer July 10. 2012 Fierce Pharma Manufacturing Executives of drug manufacturers will tell you their companies intend to meet all of the FDA&#8217;s current good manufacturing practices. Actually, their bottom lines dictate that they should. Companies that don&#8217;t do this lose sales and brand loyalty, and sometimes have to make unplanned and very [...]]]></description>
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		<title>Compliance Takes Back Seat to Quality at CDRH</title>
		<link>http://www.jehassociates.com/2012/06/compliance-takes-back-seat-to-quality-at-cdrh/</link>
		<comments>http://www.jehassociates.com/2012/06/compliance-takes-back-seat-to-quality-at-cdrh/#comments</comments>
		<pubDate>Sat, 23 Jun 2012 08:25:47 +0000</pubDate>
		<dc:creator>James E. Hamilton</dc:creator>
				<category><![CDATA[Compliance]]></category>
		<category><![CDATA[Quality]]></category>

		<guid isPermaLink="false">http://www.jehassociates.com/?p=4097</guid>
		<description><![CDATA[By: Jim Dickinson MDDI Online June 20, 2012 New initiatives at CDRH aim to help the agency take a greater emphasis on quality operations and less on compliance activities during quality system inspections, CDRH Division of Enforcement director Bill MacFarland told a Food and Drug Law Institute conference June 18. A deeper quality focus is [...]]]></description>
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