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

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

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

Training CD

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(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556


Read Frequently Asked Questions

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.

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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