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Interpreting FDA's New Guidance Document on Risk-based Monitoring

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This webinar will train you on interpreting FDA's new guidance document on risk-based monitoring. It will include a case study demonstration on how any biopharmaceutical, medical device, and CRO could leverage the applications of breakthrough techniques to implement risk-based monitoring.

Instructor: Moe Alsumidaie
Product ID: 702485

Course "Interpreting FDA's New Guidance Document on Risk-based Monitoring" has been pre-approved by RAPS as eligible for up to 1 RAC credits towards a participant's RAC recertification upon full completion.

Why Should You Attend:

The drastic changes in the global macroeconomic environment is forcing biopharmaceutical, medical device and CRO enterprises to find new ways to operate more productively, strategically and cost effectively in today's economy.

The first 30 min. of this presentation will describe the macroeconomic challenges and their effects on biopharmaceutical, medical device, and CRO industry clinical trials. Further, this section of the presentation will contain information about interpreting FDA's new guidance on risk-based monitoring practices, and will offer a case study as to how a clinical team leveraged breakthrough techniques to efficiently assess the quality of drug temperature excursions & regulatory documents and reconciled the trial master file on an outsourced study in record time, which resulted in cost savings and improved productivity.

The remaining 30 min. of the presentation will contain an engaging discussion from an expert that will cover additional details on the topics discussed, and will allow participants the opportunity to ask questions and engage in discussions with experts.

Areas Covered in the Seminar:

Who Will Benefit:

Instructor Profile:

Moe Alsumidaie, is the President and Chief Scientific Officer of Annex Clinical and the preeminent exponent of the application of Business Analytics to Clinical Trials and Healthcare Operations. Having extensive experience in Hospital Management and Phase I-IV Cardiology, Oncology, Immunology, Neurology and Medical Device clinical trials, Moe has worked for Ivy League Institutions and Fortune 500 & 100 enterprises including Stanford Medical Center, Abbott Vascular Devices, Genentech and Roche. Moe holds a BS in Physiology & Neuroscience from UC San Diego, an MBA and a MS in Investment Finance from Northeastern University’s College of Business Administration. At Annex Clinical, Moe's expertise includes financial and business analytics.

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Refund Policy
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance.
ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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COSO Framework for Internal Controls, Risk Assessment and Financial Statement Audit - 80225SEM

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Training Options Training Duration = 60 Min
$299.00 Access Recorded Version Only
One Person - Unlimited viewing for 6 Months
(For multiple licenses contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
$499.00 Get Training CD Only
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days