[Openflow-dev] Supplier Qualification - Quality Systems and Supply Chain Management

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<td style="PADDING-BOTTOM: 10px; PADDING-LEFT: 10px; PADDING-RIGHT: 0px; FONT-FAMILY: Verdana, Arial, Helvetica, sans-serif; COLOR: #006398; FONT-SIZE: 20px; CURSOR: pointer; FONT-WEIGHT: bold; TEXT-DECORATION: none; PADDING-TOP: 10px" height="auto" valign="top" width="460"><a class="topic" style="TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMa~wrTDv8S~xb~Gv8C~yJHSTsqsWf7QDEM_T7~Pv~F&amp;2=34075">Supplier Qualification - Important Part of Quality Systems and Supply Chain Management</a></td>
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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~wrTDv8S~xb~Gv8C~yJHSTsqsWf7QDEM_T7~Pv~F&amp;2=34076">Kenneth Christie</a></span><br />
<span>Date: Thursday, October 30, 2014</span><br />
<span>Time: 10:00 AM PDT | 01:00 PM EDT</span><br />
<span>Duration: 90 Minutes</span><br />
<span>Price: $243.00 Live Session for one participant</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 />
This webinar is important to the industry as all the regulations require quality assurance of the materials, components, and services that impact or are used for the final product configuration. In addition, supplier qualification is a critical portion of the quality system requirements (21 CFR 820), and companies must demonstrate control over their suppliers and the materials or services provided by them. This webinar will review the regulatory aspects of this program such as purchasing controls, evaluation of suppliers, contractors and consultants along with discussion of recent deficiencies found during their review by the inspectors.<br />
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A common approach to defining the level of control for suppliers is a risk-based approach where the higher the risk, the greater the level of control exerted. This can then be translated into whether or not on-site audits, mail-in audits or no audits are required. The webinar will provide a check list of items to be evaluated when selecting a potential supplier, and the topics to be included in a supplier agreement to answer the questions of what, when, how and who. Attendees will be given ample opportunity to ask questions regarding their current approach or to share ideas for improvement.<br />
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<span><strong>Why Should you Attend:</strong></span><br />
Attendees will walk away with not only the regulatory requirements for supplier agreements but a template of topics to use to evaluate or develop their own agreements.<br />
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<span><strong>Objectives of the Presentation:</strong></span><br />
<ul>
<li>Current regulatory requirements for supplier agreements as found in 21 CFR 820.</li>
<li>Common topics to evaluate when conducting a risk-based supplier qualification.</li>
<li>Typical things that should be covered in supplier agreements and the quality standards that should be examined.</li>
<li>Review of the typical "tools" that companies should use to assure control of their suppliers and issues relating to the handling of changes.</li>
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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 />
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<li>Engineering</li>
<li>Manufacturing directors and supervisors</li>
<li>Supply Chain Personnel</li>
<li>Purchasing</li>
<li>cGMP auditors</li>
<li>QA/QC personnel</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>Kenneth Christie</strong><br />
COO, VTS Consultants, Inc,</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">Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical and biotechnology industries. Mr. Christie is currently the Chief Operating Officer for VTS Consultants, Inc. located in Amhesrt, MA. Specifically, his responsibilities include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, medical devices and solid dosage processing equipment, utilities, and systems on a global basis. <a style="CURSOR: pointer; TEXT-DECORATION: underline"
href="http://holkoi.custhelp.com/rd?1=AvMa~wrTDv8S~xb~Gv8C~yJHSTsqsWf7QDEM_T7~Pv~F&amp;2=34079">More...</a></td>
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