[Openflow-dev] Exclusive Webinar On Batch Production Record, Device History Record and Quality Asse

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miss the chance</a></td>
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<span>Date: Wednesday, October 15, 2014</span><br />
<span>Time: 10:00 AM PDT | 01:00 PM EDT</span><br />
<span>Duration: 60 Minutes</span><br />
<span>Price:</span> <span style="TEXT-DECORATION: line-through">$243.00</span> &#160; $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 03, 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 />
Written procedures are to be established and followed for a time efficient and clear evidence of the quality related elements during the review and approval for release, including packaging and labeling, to determine compliance of the intermediates (FDA definition) and/or finished product with established specifications before a batch can be released for distribution.<br />
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BPRs, DHRs and laboratory control records for critical process steps are to be reviewed and approved by the quality unit(s) before a finished product batch is released for distribution. Production and laboratory control records for earlier, non-critical process steps may be reviewed by qualified production personnel or other units following procedures approved by the quality unit(s).<br />
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<span><strong>Why Should you Attend:</strong></span><br />
A vast majority of the current industry deficiencies which have led to isolated 483s, Warning Letters and Consent Decrees are the result of deficient technical documentation of the production processes for both injectables, devices and solid dosages.<br />
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Quality Systems require both Operations and Quality Departments to be unified with the overall intent of minimizing patient risk by documenting the process in a fashion that is technically accurate and easy to demonstrate that we are thinking and operating with the same objectives as the regulatory agencies are required to enforce.<br />
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<span><strong>Objectives of the Presentation:</strong></span>
<ul>
<li>Generation of BPRs, DHRs and SOPs to provide technically written instruction sets to eliminate operator errors. Training is NOT the primary means of generating and error free operation.</li>
<li>Production and In-Process Controls</li>
<li>Inspection, Packaging and Identification Labeling of Finished Products and Intermediates</li>
<li>Responsibilities for Production Activities</li>
<li>Data selection and entry into the statistical tracking from the BPR and DHR</li>
<li>Incident / Deviation Tracking along with Customer Complaints and CAPA changes</li>
<li>Annual Reports.</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>Quality and Documentation Personnel within the industry.</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>Jerry Dalfors</strong><br />
Principal, JD Technologies,</td>
<td valign="top" width="45" align="left"><a style="CURSOR: pointer; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMc~wr4Dv8S~xb~Gv8E~yJsSTsqsWf7QDHd_T7~Pv8U&amp;2=32774"><img alt="Image" border="0" height="40" src="http://www.onlinecompliancepanel.com/images/speakers/22194/dalfors_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">Mr. Jerry Dalfors has extensive (40+ years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages. He has held permanent employee, temporary employee and company representative management positions with a multitude of the major pharmaceutical and biotechnology companies in the US. <a style="CURSOR: pointer; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMc~wr4Dv8S~xb~Gv8E~yJsSTsqsWf7QDHd_T7~Pv8U&amp;2=32775">More...</a></td>
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[Openflow-dev] Exclusive Webinar On Batch Production Record, Device History Record and Quality Asse

[Openflow-dev] Exclusive Webinar On Batch Production Record, Device History Record and Quality Assessment