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Device Master Record & Device History Record – requirements, contents and implementation - Medical Device Webinar By ComplianceOnline

Added by Referral on 2011-01-03

Conference Dates:

Start Date Start Date: 2011-01-20

Conference Contact Info:

Contact Person Contact Person: admin
Email Email: admin@complianceonline.com
Address Address: 2600 E. Bayshore Road, Online Event,Palo Alto, CA, 94303, United States
Phone Tel: 650-620-3915
Phone Fax: 650-963-2556

Conference Description:

This webinar explains these requirements from QSR and explains the role of each document type. The webinar uses the QSR preamble to explore FDA’s thinking, FDA guidance documents for recommendations, and Warning Letters to help participants learn from other firm’s experience. This webinar provides the information about contents of the records and lessons for implementation.

Learning objectives:

State the four major records required in FDA’s QSR.
Describe the contents of the Design History File (DHF).
Explain the source of the Device Master Record (DMR).
Describe how the Device History Record (DHR) relates to the DMR.
State the required content of the Quality system Record (QSR).
Explain the difference between information if the DMR and the QSR.
Understand the concept of a “designated individual” and the qualifications.

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