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The Business Case for Quality: Reports from the MDIC Case for Quality Competency Development Working Group

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Description:

The Case for Quality has been a FDA priority since 2011. Understanding the Value of Quality was identified as a key component in driving executive understanding and building the business case for quality improvement. Two deliverables were produced: a Value of Quality whitepaper, and a Management Review Guidance. This webinar will present the content of the whitepapers and demonstrate the Cost of Poor Quality dashboard.

The webinar will also include a review of the Management Review Guidance whitepaper. Management Reviews are a key aspect of Quality Management, yet sometimes conducting an effective Management Review is a challenge because management is often unaware of the true impact of Quality on their business. Important signals can be missed and action not taken because there is little guidance on the structure, format, and content of an effective Management Review. To address this gap, the Case for Quality/Competency Working Group has developed a whitepaper and a webinar.

Date:
Thursday, May 04, 2017
Time:
11:00 AM - 12:30 PM Eastern Daylight Time
AAMI Member
$0.00
List Price
$119.00


Webinar: Improving the Postmarket Surveillance Process

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Description: In this webinar you will learn about:
  • Tools for documenting and assessing medical device events
  • A field action decision-making process that focuses on an assessment of risk and, when appropriate, an assessment of benefit; and
  • The factors important for the manufacturer to consider to facilitate transparent communication between the manufacturer and the FDA when there is uncertainty about the adverse public health issues.

  • The session will also include a brief update on revisions being considered for ISO 14971.

    Date:
    Tuesday, May 23, 2017
    Time:
    1:00 PM - 2:30 PM Eastern Daylight Time
    AAMI Member
    $0.00
    List Price
    $119.00


    Webinar: Valid Statistical Techniques for Process Validation

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    Description:

    The goal of these two webinars is demonstrate how valid statistical techniques contribute to Process Validation efforts. The content reinforces the topics covered in the Process Validation Guidance document endorsed by the Global Harmonization Task Force (GHTF). Emphasis will be placed on best practices for quality systems in industry.

    While most webinars cover the "What and Why" for a subject, these webinars will also give ideas on the "How To" for valid statistical techniques. This "How To" will cover actual examples of application and discuss methods for writing protocols and reports. The discussion of documentation is especially important for FDA-regulated companies.

    These fast-paced webinars will cover the details of application without the burden of statistical complexity. The presenter's "keep-it-simple" approach will avoid statistical complexity - participants do not need to have a background in statistics.


    Date:
    Tuesday, May 02, 2017
    Time:
    12:00 AM - 12:00 AM Eastern Daylight Time
    AAMI Member
    $299.00
    List Price
    $415.00