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Content preview: Statistical Process Control (SPC) and Control Charts –
In Accordance with Latest FDA Expectations Live Webinar | Speaker: John E
Lincoln Date: Sep 08, 2022 | Time: 01 : 00 PM EST | Duration: 90 Minutes
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Statistical Process Control (SPC) and Control Charts – In Accordance with Latest FDA Expectations
Live Webinar | Speaker: John E Lincoln
Date: Sep 08, 2022 | Time: 01 : 00 PM EST | Duration: 90 Minutes
https://click.info.mailssenders.com/?qs=81bab20bf8f20dc3bcab99bbe75aa4bc593b0087443e41b491cfc00a8e8332796118a3b5d860f62365f960c3b5f5a6dbe44fe8967a1184f3
Register Now
Statistical process control (SPC) is a method of quality control that employs statistical methods to monitor and control a process. It is one of the fifteen subpart requirements of the US FDA’s QS Regulation, 21 CFR 82, the Medical Device cGMP. It can be a key tool in meeting the Production and Process Control (P&PC) requirements of those same CGMPs and those of the Drug CGMPs, 21 CFR 211. SPC used in P&PC and the required periodic quality system analysis helps to ensure that the process operates efficiently, producing more specification-conforming products with less waste (rework or scrap). SPC provides advantages in any production process where the “conforming product” (product meeting specifications) output can be measured.
Areas Covered:-
- Required documentation / records
- SPC basics
- Regulatory requirements
- Required documentation / records
- Monitoring/control of equipment (production, test, and/or lab)
- Sample size justifications
- Verifications and/or Validations
- Trend analysis: NCMRs, Complaints, CAPAs
- Control Charts, GR&R, CpK, and other common statistical / SPC tools
- Early warning of process changes
Why You Should Attend:-
This webinar will define what is the US FDA’s expectation for the use of statistical techniques, e.g., 21 CFR 820.25, for establishing, controlling, and verifying the acceptability of process capability and product characteristics, sampling plan justifications for product acceptance or validation, and other studies. Increasingly regulatory agencies require trend analysis for non-conformances, complaints, and CAPAs as part of CGMP compliance. Subject areas considered are:
- SPC in production, test, and lab equipment
- Sampling plan justification
- Verifications and validations
- Trending: Non-conformances, complaints, and CAPAs
For more for 6+ attendees call us at +1-844-899-4647 or mail us at [email protected]
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<div class="preheader" style="font-size: 1px; display: none !important;">Live Webinar!</div>
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<table cellpadding="0" cellspacing="0" width="100%" role="presentation" style="min-width: 100%; " class="stylingblock-content-wrapper"><tr><td class="stylingblock-content-wrapper camarker-inner"><p style="text-align: center; line-height: 1.5;"><strong><span style="font-family: Georgia, serif; font-size: 18px;">Statistical Process Control (SPC) and Control Charts – In Accordance with Latest FDA Expectations</span></strong></p>
<p style="text-align: center;"><span style="font-size: 20px; font-family: Georgia, serif;">Live Webinar | <strong>Speaker:</strong> John E Lincoln</span></p>
<hr>
<p style="text-align: center;"><span style="font-size: 20px;"><strong>Date:</strong> Sep 08, 2022 | <strong>Time:</strong> 01 : 00 PM EST | <strong>Duration:</strong> 90 Minutes</span></p>
<p style="text-align: center;"><span style="font-size: 20px;"><a href="https://click.info.mailssenders.com/?qs=81bab20bf8f20dc3bcab99bbe75aa4bc593b0087443e41b491cfc00a8e8332796118a3b5d860f62365f960c3b5f5a6dbe44fe8967a1184f3"><strong><span style="font-family: Georgia, serif;">Register Now</span></strong></a></span></p>
<p>
<span style="font-size: 16px; font-family: Georgia, serif;">Statistical process control (SPC) is a method of quality control that employs statistical methods to monitor and control a process. It is one of the fifteen subpart requirements of the US FDA’s QS Regulation, 21 CFR 82, the Medical Device cGMP. It can be a key tool in meeting the Production and Process Control (P&PC) requirements of those same CGMPs and those of the Drug CGMPs, 21 CFR 211. SPC used in P&PC and the required periodic quality system analysis helps to ensure that the process operates efficiently, producing more specification-conforming products with less waste (rework or scrap). SPC provides advantages in any production process where the “conforming product” (product meeting specifications)
output can be measured.</span></p>
<p><span style="font-size: 16px; font-family: Georgia, serif;"><strong>Areas Covered:-</strong></span></p>
<ul>
<li style="font-size: 16px; font-family: Georgia, serif;">Required documentation / records</li>
<li style="font-size: 16px; font-family: Georgia, serif;">SPC basics</li>
<li style="font-size: 16px; font-family: Georgia, serif;">Regulatory requirements</li>
<li style="font-size: 16px; font-family: Georgia, serif;">Required documentation / records</li>
<li style="font-size: 16px; font-family: Georgia, serif;">Monitoring/control of equipment (production, test, and/or lab)</li>
<li style="font-size: 16px; font-family: Georgia, serif;">Sample size justifications</li>
<li style="font-size: 16px; font-family: Georgia, serif;">Verifications and/or Validations</li>
<li style="font-size: 16px; font-family: Georgia, serif;">Trend analysis: NCMRs, Complaints, CAPAs</li>
<li style="font-size: 16px; font-family: Georgia, serif;">Control Charts, GR&R, CpK, and other common statistical / SPC tools</li>
<li style="font-size: 16px; font-family: Georgia, serif;">Early warning of process changes</li>
</ul>
<p><span style="font-size: 16px; font-family: Georgia, serif;"><strong>Why You Should Attend:-</strong></span></p>
<p><span style="font-size: 16px; font-family: Georgia, serif;">This webinar will define what is the US FDA’s expectation for the use of statistical techniques, e.g., 21 CFR 820.25, for establishing, controlling, and verifying the acceptability of process capability and product characteristics, sampling plan justifications for product acceptance or validation, and other studies. Increasingly regulatory agencies require trend analysis for non-conformances, complaints, and CAPAs as part of CGMP compliance. Subject areas considered are:</span></p>
<ul>
<li style="font-size: 16px; font-family: Georgia, serif;">SPC in production, test, and lab equipment</li>
<li style="font-size: 16px; font-family: Georgia, serif;">Sampling plan justification</li>
<li style="font-size: 16px; font-family: Georgia, serif;">Verifications and validations</li>
<li style="font-size: 16px; font-family: Georgia, serif;">Trending: Non-conformances, complaints, and CAPAs</li>
</ul>
<p style="text-align: center;"><strong><span style="font-size: 18px;">For more for 6+ attendees call us at +1-844-899-4647 or mail us at [email protected]</span></strong></p><img src="https://click.info.mailssenders.com/open.aspx?ffcb10-febc1674726c037a-fe29167477640775731277-fe3311737164047c711374-ff2f17717d60-fe2b10797d60067f751774-ff971074&d=120004&bmt=0" width="1" height="1" alt=""></custom></td></tr></table><p style="text-align: center;">If you don't want to hear from us
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