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

Instructor: Moe Alsumidaie
Product ID: 702485
  • Duration: 60 Min
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.

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Oct-2012

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

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:

  • Global macroeconomic challenges & their effects on clinical trials.
  • Interpretation of FDA's new guidance document on risk-based monitoring.
  • Case study on risk-based monitoring.
  • ICH/GCP in the new economy.
  • Implementation of breakthrough tools to save costs, improve productivity, optimize monitoring operations and enhance clinical trial operational strategy.
  • Efficiently improving clinical trial quality through risk-based monitoring.

Who Will Benefit:

  • Clinical Quality Directors, Managers & Associates
  • QA Directors, Managers & Associates
  • Compliance VPs, Directors, Managers & Associates
  • Clinical Operations Directors, Managers & Associates
  • Clinical Research Directors, Managers & Associates
  • Clinical Trial Directors, Managers & Associates
  • Regulatory Affairs Directors, Managers & Associates
  • CRO, Medical Device, Biotechnology, Pharmaceutical Clinical Development Executives

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.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email call +1-888-717-2436 (Toll Free).

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