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[Openflow-dev] Understanding USP Monographs and Review Process
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From: onlinecompliancepanel <hol...@rn...> - 2014-11-04 15:24:17
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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=AvMi~wqKDv8S~xb~Gv84~yL~STsqsWf7QDHq_T7~Pv8j&2=44395">Things to know when Working with Compendial (USP) Procedures</a></td>
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<span>Instructor: <a class="sub_head3" style="CURSOR: pointer; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMi~wqKDv8S~xb~Gv84~yL~STsqsWf7QDHq_T7~Pv8j&2=44396">Kim Huynh-Ba</a></span><br />
<span>Date: Wednesday, November 12, 2014</span><br />
<span>Time: 10:00 AM PST | 01:00 PM EST</span><br />
<span>Duration: 60 Minutes</span><br />
<span>Price:</span> <span style="TEXT-DECORATION: line-through">$249.00</span>   $212 Live Session for one participant<br />
Offer valid till November 11, 2014</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 />
Documentary standards published in the US Pharmacopeia-National Formulary (USP-NF) are recognized as the legal standards for prescription and non-prescription medicines distributed in the United States. They contain required information for compendial testing identity, strength, quality, purity, packaging, prescription labels and drug warning labels of compendial products. These monographs are included for drug products, drug substances, veterinary products, excipients, dietary supplements, compounding preparations and more. In addition, there are important sections, including General Notices and General Chapters to guide acceptable practices when working with compendial testing procedures.<br />
<br />
<span><strong>Why Should you Attend:</strong></span><br />
Drug substances and drug products must meet the requirements listed in the correspondent documentary standards. Therefore, having an understanding of what they are and their impacts are critical.<br />
<br />
<span><strong>Objectives of the Presentation:</strong></span><br />
<ul>
<li>Overview of USP Organization</li>
<li>Understanding USP Monographs and the Review process</li>
<li>What is USP Reference Standards</li>
<li>Impact of General Chapters and General Notices.</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>
<ul>
<li>Laboratory scientists</li>
<li>Supervisors and managers</li>
<li>Regulatory scientists</li>
<li>Quality Assurance and Quality Control Scientists</li>
<li>Compliance officers in pharmaceutical and allied industries.</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>Kim Huynh-Ba</strong><br />
Executive Director of Pharmalytik,</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">Kim Huynh-Ba has over 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She currently is the Executive Director of Pharmalytik, where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA's Consent Decree on harmonization and optimization of analytical best practices since 2003. Her clients are from various sizes of pharmaceutical companies in the US and abroad. <a style="CURSOR: pointer; TEXT-DECORATION: underline"
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