ComplianceOnline

Tracking Use Error Risks in Post-Market Surveillance and CAPA Activities

Instructor: Robert A North
Product ID: 700912
  • Duration: 60 Min

recorded version

$249.00
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: Jul-2008

Training CD

$500.00
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

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This webinar will apply to manufacturers with devices that require user-device interactions to set-up, operate, and maintain the device as well as track post market risks.

Description

Participants in this webinar will learn about techniques that will be useful in analysis of post market human factors design problems and in preventing these problems through pro-active use of post-market surveillance techniques and customer support data.

This webinar will apply to manufacturers with devices that require user-device interactions to set-up, operate, and maintain the device, and manage post market safety risks regarding use-related hazards. The FDA reports that over half of reported adverse events can be classified as design related. That estimate includes many instances of use related incidents linked to poor design of the user interface causing confusion, misuse, and inadvertent actions leading to patient or caregiver injuries or deaths. Ignoring problems related to user error is not an acceptable response to the FDA and is considered nonconformity. Participants in this webinar will learn about techniques that will be useful in analysis of post market human factors design problems and in preventing these problems through pro-active use of post-market surveillance techniques and customer support data.

Areas Covered in the seminar:

  • What the FDA expects if a use error causes an adverse event.
  • Building in use error analysis in post-market assessment of device risks.
  • Techniques for quickly classifying use errors into design-related causes.
  • How post-market use error data can be fed back to the design team efficiently.
  • Questions your customer service department should be asking to identify use related hazards.

Who will benefit:

This webinar will apply to manufacturers with devices that require user-device interactions to set-up, operate, and maintain the device as well as track post market risks. Focus is on Job functions that will benefit include:

  • Research and Development functions: risk management, hazard analysis, FMEA teams
  • Regulatory and Compliance: those involved in responding to CAPA events
  • Risk Management teams
  • Customer Service Departments and Post Market Surveillance teams
  • Consultants
  • Operations and Manufacturing

Instructor Profile:
Robert A. North, PhD, is Chief Scientist of Human Centered Strategies, LLC specializing in creating strategies for applying Human Factors methods to medical device risk management and overall device effectiveness for several major manufacturers. Bob has worked as consultant to FDA/CDRH on analysis methods for use errors in adverse events, and is a member of the AAMI Human Factors Standards Committee currently developing a new standard for best practices. He has also recently served as faculty for Advamed (MTLI) in recent Design Controls seminars representing the FDA position on human factors. He is author or co-author on several articles appearing in MDDI’s Device Link (on-line) and is on the faculty of the Regulatory Affairs Professional Society’s (RAPS) 2008 Horizons Conference, presenting seminars on use error risk management strategies.

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Risk Management in Medical Devices Industry

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 customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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