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[Openflow-dev] Exclusive Webinar On Statistical Confidence for Pharma Process Performance Qualification (PPQ)
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From: onlinecompliancepanel <hol...@rn...> - 2014-10-21 14:33:29
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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: 12px; CURSOR: pointer; FONT-WEIGHT: normal; TEXT-DECORATION: none; PADDING-TOP: 10px" height="auto" valign="top" width="460"><a style="LINE-HEIGHT: 20px; COLOR: #333333; FONT-SIZE: 12px; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMm~wqMDv8S~xb~Gv8_~yIASTsqsWf7QDH4_T7~Pv8x&2=40012">Widen your knowledge on <span style="FONT-STYLE: italic; COLOR: #cc0000; FONT-SIZE: 12px; FONT-WEIGHT: bold">Pharmaceutical</span> by attending this exclusive webinar on <span style="COLOR: #006398; FONT-SIZE: 17px; FONT-WEIGHT: bold">Qualification Sample Size and Statistical Confidence for Pharma Process Performance Qualification
(PPQ)</span><br />
Do not miss the chance</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=AvMm~wqMDv8S~xb~Gv8_~yIASTsqsWf7QDH4_T7~Pv8x&2=40013">Marvin Iglehart</a></span><br />
<span>Date: Thursday, November 6, 2014</span><br />
<span>Time: 11:30 AM PDT | 02:30 PM EDT</span><br />
<span>Duration: 90 Minutes</span><br />
<span>Price:</span> <span style="TEXT-DECORATION: line-through">$243.00</span>   $235 Live Session for one participant<br />
<span style="LINE-HEIGHT: 30px; COLOR: #cd0e20">Super combo offer Live + Training CD at <span style="TEXT-DECORATION: line-through">$549.00</span> $439</span><br />
Offer valid till October 26, 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 />
This webinar will discuss the requirements and general expectations for Stage 2 - Process Qualification, the key concepts that lead to the basis of confidence level and/or statistical confidence and how to apply the concepts in practical use for validation, including acceptance criterion.<br />
<br />
The demonstration of process capability and process stability poses challenges for some manufacturers of Pharma products as they transit from Stage 1 - Process Design to Stage 2 - Process Qualification including that Stage 2 - Process Qualification applies to both new product launches and legacy products under change control.<br />
<br />
<span><strong>Why Should you Attend:</strong></span><br />
This 90-minute session will provide an overview of Stage 2 - Process Validation - using practical examples that you can apply when validating your products. We will discuss the approaches and statistical calculations required to execute Stage 2 - Process Qualification - based on statistical confidence. The instructor will provide examples for practical application of the determination of sample size, confidence, and process capability when balancing risk. You will learn how to connect the guidance and requirements for statistical confidence to statistical rationale, deliverables, and validation acceptance criterion that can stand the challenge of an audit.<br />
<br />
<span><strong>Objectives of the Presentation:</strong></span>
<ul>
<li>The main objectives of the presentation are to provide:
<ul>
<li>An overview of FDA Guidance</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>Process Capability</li>
<li>Process Stability</li>
</ul>
</li>
<li>Definitions and Concepts that Lead to the Basis of Confidence Level and Statistical Confidence</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>Confidence Level</li>
<li>Risk and Confidence Level</li>
<li>Example Confidence Equations</li>
<li>Application of ASTM E2281-08a (2012) Standard Practice for Process and Measurement Capability Indices</li>
</ul>
</li>
<li>Minimum Batches vs Confidence Level</li>
<li>Statistical Rationale Examples</li>
<li>PPQ Examples including Acceptance Criterion with Statistical Confidenc</li>
</ul>
</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 is targeted mainly to manufacturers of pharmaceutical products and biopharmaceuticals. The personnel who will benefit include:
<ul>
<li>Validation Managers</li>
<li>Validation Engineers</li>
<li>QA and Auditing Professionals</li>
<li>Regulatory Professionals</li>
<li>Scientists</li>
<li>Product, process and formulation development</li>
<li>Personnel in analytical development</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>Marvin Iglehart</strong><br />
Principal QE and Validation Consultant, Alcon Laboratories, Inc,</td>
<td valign="top" width="45" align="left"><a style="CURSOR: pointer; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMm~wqMDv8S~xb~Gv8_~yIASTsqsWf7QDH4_T7~Pv8x&2=40015"><img alt="Image" border="0" height="40" src="http://www.onlinecompliancepanel.com/images/speakers/24158/iglehart_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">Marvin Iglehart, SSMBB has over 15 years of combined Compliance, Quality Systems and Quality Assurance experience related to FDA cGMP's, Part 820, Parts 210/211, Q10, GLP's, Part 11, ISO 13485, & ISO 1497. He currently is the Principal Consultant of Quality Systems and Continuous Improvement (QS&CI) Consulting, LLC, where he provides consulting and training services to medical device and pharmaceutical companies. <a style="CURSOR: pointer; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMm~wqMDv8S~xb~Gv8_~yIASTsqsWf7QDH4_T7~Pv8x&2=40016">More...</a></td>
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