ComplianceOnline

Develop a Device Master Record that can assist with Device History Record Review

Instructor: Mary Nunnally
Product ID: 705328
  • 20
  • September 2017
    Wednesday
  • 11:30 AM PDT | 02:30 PM EDT
    Duration: 60 Min

Live Online Training
September 20, Wednesday 11:30 AM PDT | 02:30 PM EDT | Duration: 60 Min

$199.00
One Dial-in One Attendee
$499.00
Group-Max. 10 Attendees/Location
(For Multiple Locations Contact Customer Care)
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recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training

Training CD

$349.00
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CD and Ref. material will be shipped within 15 business days after completion of Live training

Combo Offers

Live + Recorded Version

$349.00

Live + Training CD

$399.00

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This webinar provides a basic understanding of the records required to fulfill requirements of both US FDA 21CFR 820 and ISO 13485:2016 for establishment and maintenance of a Device Master Record. It will further discuss the responsibilities of various development team members such as R&D/engineering, operations, quality assurance, project management and executive management.

Why Should You Attend:

This webinar will cover basic requirements for the content of a Device Master Record for compliance to 21CFR 820 and ISO 13485:2016 and will review potential differences in the requirements between the two regulatory standards. It will further discuss the difference between a Device Master Record (DMR) and a Device History Record (DHR) including the differences, if any, between a device Batch Record and a Device History Record?

Attendees will learn how a DMR can assist with compilation and quality assurance review of a DHR – especially for device products with multiple components. It will further help them understand what document control means for DMR documents (records).

Areas Covered in the Webinar:

  • Records required for the Device Master Record
  • How to use the Device Master Record to develop a method for efficient Device History (Record Batch Record) review and product release?
  • What are the responsibilities of various development team members – such as R&D/engineering, operations, quality assurance, project management and executive management?
  • When should a Device Master Record be established for a product in development?

Who Will Benefit:

  • Quality assurance personnel responsible for compliance audits of Device History Records and subsequent medical device product release
  • Operations personnel responsible for production of medical devices
  • R & D scientists within the medical device Industry
  • Project managers working with medical device development teams
Instructor Profile:
Mary Nunnally

Mary Nunnally
President, Translational Medicine LLC

Mary H Nunnally, PhD, is an experienced Quality and Operations Executive (20+ years) within the medical device, biomedical research product, veterinary medicine and pharmaceutical industries. She has an extensive hands-on experience in the establishment and maintenance of US FDA 21CFR 820, ISO 13485 and ISO 9001certified Quality Systems, including implementation of all systems required for compliance with US, CMDR, and EU regulatory statutes.

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

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