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Content preview: Dear Colleagues, We are back with something GRAND again…...
Join in 6- Hour Boot Camp on Computer System Validation – Managing
Computers Regulated by FDA with Carolyn Troiano on Jul 06, 2022 - Jul 08,
2022 at 01: 00 PM EST for 360 minutes.
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Dear Colleagues,
We are back with something GRAND again…...
Join in 6- Hour Boot Camp on Computer System Validation – Managing Computers Regulated by FDA with Carolyn Troiano on Jul 06, 2022 - Jul 08, 2022 at 01: 00 PM EST for 360 minutes.
https://click.info.mailssenders.com/?qs=5722887cdbf625f509c699d1a34bc19917666d170291d895594a0273976b3aa6bab939a592f11ed3b87c1d0ddc98805d6d51bda24fff1ec4
Register Now and Celebrate Your Liberty! Use Code "OAW40" & Save $40. Offer Valid till July 4, 2022
About the Live Webinar:
As regulated by the FDA, in-depth exploration is utmost for the validation of computer systems. This boot camp will cover multiple approaches, techniques, and tools that can improve the efficiency and effectiveness of validation activities. You will go through the phases of validation, including deliverables and FDA requirements. You will also learn about 21 CFR Part 11, FDA’s guidance for electronic records and signatures, and FDA’s guidance on Data Integrity.
About the speaker:
Carolyn Troiano owes more than 35 years of experience in the field of computer system validation and compliance in pharmaceutical, medical devices, tobacco, and other FDA-regulated industries.
Learning Agenda:
Day 1 - July 6, Wednesday, 2022 (1:00 PM to 3:00 PM)
-
GxP” Systems
-
Computer System Validation (CSV)
-
Computer Software Assurance (CSA)
-
System Development Life Cycle (SDLC)
-
CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11
-
Validation deliverables, including the Validation Plan, Requirements Specification, Test Plan, Validation Tests (IQ, OQ, PQ), Requirements Traceability Matrix, Test Summary, and Validation Report, etc.
Day 2 - July 7, Thursday, 2022 (1:00 PM to 3:00 PM)
-
Develop a cohesive and comprehensive validation rationale
-
Comprehend a risk-based validation technique
-
Learn appropriate validation strategies for Cloud/SaaS, COTS, spreadsheets, and custom-developed systems
-
Learn best practices for documenting validation
-
Maintain a system in a validated state
-
Assure the integrity of data that supports GxP work
Day 3 - July 8, Friday, 2022 (1:00 PM to 3:00 PM)
-
Policies and procedures needed to support validation
-
FDA’s current thinking and trends
-
FDA inspection or audit preparation
-
Vendor Audit
-
Understand the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle
-
Q&A
Want to have a real-world experience with computer system validation? Here is the chance to not only FDA, ICH, and EudraLex expectations for risk-based validation, but to implement these practices in building your organization.
Facing any issues, give us a call at +1-866-823-1483 or mail us at [email protected]
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<div class="preheader" style="font-size: 1px; display: none !important;">21 CFR Part 11 FDA’s guidance</div>
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Dear Colleagues,</p><p>
We are back with something GRAND again…...</p><p>
Join in <strong>6- </strong><strong>Hour Boot Camp on Computer System Validation – Managing Computers Regulated by FDA </strong>with <strong>Carolyn Troiano</strong><strong> </strong>on<strong> Jul 06, 2022 - Jul 08, 2022 </strong>at <strong>01: 00 PM EST </strong>for 360 minutes.</p><p>
<a href="https://click.info.mailssenders.com/?qs=5722887cdbf625f509c699d1a34bc19917666d170291d895594a0273976b3aa6bab939a592f11ed3b87c1d0ddc98805d6d51bda24fff1ec4"><strong>Register Now</strong></a> and Celebrate Your Liberty! Use Code <b>"OAW40"</b> & Save <b>$40</b>. Offer Valid till July 4, 2022<br>
<br>
<strong>About the Live Webinar:</strong></p><p>
As regulated by the FDA, in-depth exploration is utmost for the validation of computer systems. This boot camp will cover multiple approaches, techniques, and tools that can improve the efficiency and effectiveness of validation activities. You will go through the phases of validation, including deliverables and FDA requirements. You will also learn about 21 CFR Part 11, FDA’s guidance for electronic records and signatures, and FDA’s guidance on Data Integrity.</p><p>
<strong>About the speaker: </strong></p><p>
Carolyn Troiano owes more than 35 years of experience in the field of computer system validation and compliance in pharmaceutical, medical devices, tobacco, and other FDA-regulated industries.</p><p>
<strong>Learning Agenda: </strong></p><p>
<strong>Day 1 - <strong>July 6, Wednesday, 2022 (1:00 PM to 3:00 PM)</strong></strong></p><ul type="disc">
<li>
GxP” Systems</li><li>
Computer System Validation (CSV)</li><li>
Computer Software Assurance (CSA)</li><li>
System Development Life Cycle (SDLC)</li><li>
CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11</li><li>
Validation deliverables, including the Validation Plan, Requirements Specification, Test Plan, Validation Tests (IQ, OQ, PQ), Requirements Traceability Matrix, Test Summary, and Validation Report, etc.</li></ul><p>
<strong>Day 2 - <strong>July 7, Thursday, 2022 (1:00 PM to 3:00 PM)</strong></strong></p><ul type="disc">
<li>
Develop a cohesive and comprehensive validation rationale</li><li>
Comprehend a risk-based validation technique</li><li>
Learn appropriate validation strategies for Cloud/SaaS, COTS, spreadsheets, and custom-developed systems</li><li>
Learn best practices for documenting validation</li><li>
Maintain a system in a validated state</li><li>
Assure the integrity of data that supports GxP work</li></ul><p>
<strong>Day 3 </strong>- <strong>July 8, Friday, 2022 (1:00 PM to 3:00 PM)</strong></p><ul type="disc">
<li>
Policies and procedures needed to support validation</li><li>
FDA’s current thinking and trends</li><li>
FDA inspection or audit preparation</li><li>
Vendor Audit</li><li>
Understand the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle</li><li>
Q&A</li></ul><p>
Want to have a real-world experience with computer system validation? Here is the chance to not only FDA, ICH, and EudraLex expectations for risk-based validation, but to implement these practices in building your organization. </p><p>
Facing any issues, give us a call at +1-866-823-1483 or mail us at [email protected]</p></td></tr></table><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"><div style="text-align: center;">
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