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Risk Based Approach to Clinical Trial Quality Assurance - NCDG Roundtable (...

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Stellartech Research Corporation

560 Cottonwood Drive

Milpitas, CA 95035

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The Northern California Discussion Group of the ASQ Biomedical Division Presents the April 2017 Roundtable on:

Risk-Based Approach to Clinical Trial Quality Assurance

Wednesday, April 26, 2017, 7:00 to 9:00 pm

Register for online discounts - ahead of the roundtable event.

Topic: ICH E6 Guideline for Good Clinical Practice, FDA Title 21 CFR 11, 50, 54, 56, 312, Investigational Device Exemption (IDE), EU Clinical Trial Directives 2001/20/EC and 2005/28/EC and EU Guidelines on Clinical Investigation of medical devices requirements call out for the type and extent of quality assurance and quality controls to be established and documented and applied during Clinical Trials.

Building quality plans during the initial planning stages by incorporating quality management approach into clinical studies and their oversight allows to prevent the critical errors, and monitor for those errors real time centrally and focus less on the less important matters.

Maintaining accuracy, completeness, and quality throughout a clinical study is a continual and dynamic process. Even though study requirements are carefully set forth initially in detailed documents such as an approved agreement, clinical plan, protocol, and a data management plan, expectations and requirements can change during a study due to design updates or regulatory feedbacks. This ongoing process requires revising mechanisms and communicating these revisions clearly to all investigators and support staff.

Risk based approach involves determining specific sources of risk and its effect on the clinical trial. This allows for risk mitigation plan for communicating risks to everyone involved in the conduct of the clinical trials.

In this presentation, we will focus on applying the risk based approach to the important clinical trial processes like

  • Scientifically valid and ethically sound experimental design
  • Adequate protection of subject’s rights, safety, and welfare
  • Qualified and trained personnel
  • Adequate monitoring
  • Reported trial data are accurate, complete, and verifiable from source documents
  • Conduct the trial in compliance with currently approved protocol/amendment(s), GCP, and applicable regulatory requirement(s).

Featured Speaker: Bill Kurani -

Bill Kurani

Bill has extensive experience in the area of regulatory affairs and quality assurance of the medical device. Mr. Kurani has helped several medical device companies implement successful product design, development, verification, validation, manufacturing process, and supplier evaluation programs. He has done hazard and risk analysis on many aspects of the medical device product and manufacturing process including supplier evaluation and audits before regulatory clearances and approvals. Bill earned his MSRA at San Diego State University, MSEE at LSU, and Biomedical Certificate at Stanford University.

Moderator: Dishita Purohit is Chair, Northern California Biomedical Discussion Group (NCDG).

Location: Stellartech Research Corporation, 560 Cottonwood Dr., Milpitas, CA 95035

Food: Snacks equivalent to a light meal and beverages are provided at each event at no additional cost.

Email: To be added to or removed from our email list, contact George Marcel (gjmarcel@gmail.com).

Registration Link: ncdgapr2017.eventbrite.com

ONLY Check or Credit Card accepted at door

Questions: For information about this session, contact Gary Seeger (gseeger@stellartec.com)

Formal discussion and questions will end between 8:30 - 8:45 pm to allow time for networking after the roundtable presentation.


Remote Access:

If you are unable to attend in person, you can still join the Roundtable remotely via webinar link at no cost:

(Note: Presentation Materials or RU credits not provided if remote access).

Webinar link for April Roundtable



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Stellartech Research Corporation

560 Cottonwood Drive

Milpitas, CA 95035

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