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	<title>Medpoint &#187; Research and Development</title>
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		<title>L.S.D.</title>
		<link>http://www.medpoint.com/lsd-texas/</link>
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		<pubDate>Thu, 30 Oct 2008 17:00:37 +0000</pubDate>
		<dc:creator>PECULIAR</dc:creator>
				<category><![CDATA[Consultant Profiles]]></category>
		<category><![CDATA[Management]]></category>
		<category><![CDATA[Medical Device]]></category>
		<category><![CDATA[Pharmaceutical]]></category>
		<category><![CDATA[Quality Systems]]></category>
		<category><![CDATA[Regulatory Affairs]]></category>
		<category><![CDATA[Research and Development]]></category>

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		<description><![CDATA[Thirty years experience in the Pharmaceutical and high-tech Medical Device industry. Extensive knowledge of Product Development, R&#38;D, Program Management, Quality Systems and Compliance, and Regulatory submissions. Titles Held: Senior Vice President, Chief Scientific Officer; Principal; Senior VP Scientific Affairs; Executive Director RA/QA and Clinical Affairs; Manager, RA/QA; Senior Design Engineer Strong validation experience in product and [...]]]></description>
			<content:encoded><![CDATA[<p><img class="alignright size-full wp-image-167" title="m_sil_02" src="http://medpoint.timpecoraro.com/wp-content/uploads/2008/10/m_sil_02.gif" alt="" width="82" height="181" />Thirty years experience in the Pharmaceutical and high-tech Medical Device industry. Extensive knowledge of Product Development, R&amp;D, Program Management, Quality Systems and Compliance, and Regulatory submissions.</p>
<p>Titles Held: Senior Vice President, Chief Scientific Officer; Principal; Senior VP Scientific Affairs; Executive Director RA/QA and Clinical Affairs; Manager, RA/QA; Senior Design Engineer</p>
<ul>
<li>Strong validation experience in product and process validation requirements in various countries and management of the design, implementation, and documentation of validation programs for numerous (100+) products around the world</li>
<li>Experience with warning letters and consent decree situations with both domestic and international firms</li>
<li>Successfully designed, developed, and certified clean room facilities in several countries and for a wide range of products</li>
<li>Qualified in conducting clinical trials for IDEs and PMAs as well as clinical evaluations for market penetration purposes</li>
<li>Experience with all device classes:lasers (Surgical and Ophthalmic), to implants (Orthopedic and Ophthalmic), to a wide range of electronic products, disposables, IVDs, and biologics (homologous bone grafts)</li>
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