[Openflow-dev] Merger and Consolidation of FDA Guidance Documents and Regulations

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<td style="PADDING-BOTTOM: 10px; LINE-HEIGHT: 20px; PADDING-LEFT: 10px; PADDING-RIGHT: 0px; FONT-FAMILY: Verdana, Arial, Helvetica, sans-serif; COLOR: #333333; FONT-SIZE: 11px; FONT-WEIGHT: bold; TEXT-DECORATION: none; PADDING-TOP: 0px" class="time" height="auto" valign="top" width="460"><span>Instructor: <a class="sub_head3" style="CURSOR: pointer; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMa~wqiDv8S~xb~Gv8C~yIWSTsqsWf7QDGs_T7~Pv9l&amp;2=35399">Howard T Cooper</a></span><br />
<span>Date: Wednesday, 05 November 2014</span><br />
<span>Time: 11:30 AM PDT | 02:30 PM EDT</span><br />
<span>Duration: 75 Minutes</span><br />
<span>Price: $199.00 Live Session for one participant</span><br />
<span style="LINE-HEIGHT: 30px; COLOR: #cd0e20">Super combo offer Live + Training CD at $499.00</span></td>
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<td style="PADDING-BOTTOM: 0px; PADDING-LEFT: 10px; PADDING-RIGHT: 10px; PADDING-TOP: 10px" class="content" height="auto" valign="top" width="460"><span><strong>Webinar Description:</strong></span><br />
While the FDA regulated industry has continued to rely on a compliance-based quality system, other industries have achieved far greater accomplishments satisfying customer needs and requirements. The 1978 medical device regulations began to break this mode by placing the responsibility of achieving customer requirements through management accountability and responsibility. ICH Q7A (2001) defines quality and production responsibilities with management responsibilities implied through internal audit. The 2006 FDA "Quality Systems Approach" further enhanced defining of responsibilities. Then, in 2008, ICH Q10 focused on the important role Of Senior Management Responsibility to direct resources to meet customer quality requirements.<br />
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This webinar will discuss and analyze the differences between the above guidance documents and regulations, then show ways to document and implement these responsibilities. Merging and consolidation of these will be emphasized.<br />
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<span><strong>Why Should you Attend:</strong></span>
<ul>
<li>By attending this webinar, you will gain a better understanding of the interdepartmental activities and their roles and interactions, in order to operate more effective, go beyond maintaining compliance, and improve these activities.</li>
<li>Assist in the preparation of policies and SOP's.</li>
</ul>
<span><strong>Objectives of the Presentation:</strong></span>
<ul>
<li>Introduction, Purpose and Background</li>
<li>RASCI-The Roles of Responsible, Accountable, Supportive, Consultative, &amp; Informative</li>
<li>What is The Role of Responsibility?</li>
<li>The historical perspective of responsibility and accountability in the regulation of pharmaceuticals.</li>
<li>Direct &amp; Implied Responsibilities In the Regulations and Guidance Documents-ICH Q10, Q7A, Part 210-211, &amp; Part 606, &amp; the FDA's Quality Systems Approach</li>
<li>Shifting roles-the "Brick &amp; Mortar" vs "Virtual Company"</li>
<li>Roles and Responsibilities in the Product &amp; The Manufacturing Lifecycles</li>
<li>Auditing existing system for compliance to requirements and identifying improvements for greater effectiveness</li>
<li>Using the quality manual to define and implement responsibility and accountability.</li>
<li>A quick and efficient technique to define responsibilities in an organization.</li>
<li>Handouts to illustrate the subject matter of this topic</li>
</ul>
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<td style="PADDING-LEFT: 10px" class="content" height="auto" valign="top" width="242"><span><strong>Who can Benefit:</strong></span><br />
This webinar will benefit all departments related to pharmaceutical industries. Below is a list professional who csn benefit from this webinar.
<ul>
<li>QA &amp; QC</li>
<li>Senior Management</li>
<li>Research and Development</li>
<li>Regulatory Affairs</li>
<li>Senior &amp; Junior Management</li>
<li>Purchasing &amp; Finance</li>
<li>Engineering and Maintenance</li>
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<td style="PADDING-LEFT: 10px" class="content" height="35" valign="center" colspan="2" align="left"><strong>Instructor Profile:</strong></td>
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<td style="PADDING-LEFT: 10px" class="content" height="auto" valign="top" width="197"><strong>Howard T Cooper</strong><br />
President, EQACT,INC</td>
<td valign="top" width="45" align="left"><a style="CURSOR: pointer; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMa~wqiDv8S~xb~Gv8C~yIWSTsqsWf7QDGs_T7~Pv9l&amp;2=35401"><img alt="Image" border="0" height="40" src="http://www.onlinecompliancepanel.com/images/speakers/20544/howard_32_40.jpg" width="32" /></a></td>
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<td style="PADDING-BOTTOM: 10px; PADDING-LEFT: 10px; PADDING-RIGHT: 10px; PADDING-TOP: 0px" class="content" height="auto" valign="top" width="242">Howard T Cooper has over 40 years’ experience managing, designing, developing, implementing, and mitigating GMP quality systems in the pharmaceutical, medical device, nutraceutical, &amp; food industries. He started his quality career at Anheuser-Busch as a quality management trainee which provided a very advanced and preventative approach toward quality systems. He quickly advanced to a managerial role experiencing responsibilities for quality management, quality system mitigation, and startup of new breweries. <a style="CURSOR: pointer; TEXT-DECORATION: underline"
href="http://holkoi.custhelp.com/rd?1=AvMa~wqiDv8S~xb~Gv8C~yIWSTsqsWf7QDGs_T7~Pv9l&amp;2=35402">More...</a></td>
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