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Online Webinar
10 Apr 2015
Science

Conformance of Design History Files for Mature Medical Devices

In this webinar, we will discuss practical steps you can follow to bring your product design history files up to current standards.

Description : This webinar on Design History Files (DHF) will provide a step-by-step procedure for all medical device companies that are in need of bring their product design history files up to date with the current standards.Many medical industry companies have not brought their old product lines up to current FDA standards and are not in total compliance. This webinar defines the procedures to be followed for medical products design history file remediation.Areas Covered in the Session :Multi-functional team approach/responsibility.Set procedures and template to complete remediation for design history file of old devices to meet current standards.Gap analysisData gathering to build the design history filesRisk procedureRisk assessment for prioritizing remediationValidationsDealing with the FDAPhase by phase check list.Who Will Benefit:This webinar will provide valuable assistance and give a procedure to all regulated companies that need to bring their product design history files up to date with current standards. The employees who will benefit include:Senior managementEnd-users responsible for design control and technical files that need to be updated to the current standardsR&D and product developmentProcess engineers and managersOperations and plant managementValidation engineersRemediation teamsDocumentation teamsQA, Regulatory AffairsQC and Corporate AuditorsAll team members who contribute to design history, clinical, validations or technical filesConsultantsAll Contract Manufacturers working in the medical industryPrice tags:LiveSingle Live : For One Participant$ 249Corporate Live : For Max. 10 Participants$ 899RecordingSingle REC : For One Participant - Unlimited Access for 6 Months$ 299For more information and enquiries contact us atCompliance Trainings5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada  Customer Support : #416-915-4458 

When

10 Apr 2015 @ 01:00 pm

10 Apr 2015 @ 02:00 pm

Duration: 1 hours

Timezone: GMT -5:00


Where

Online Webinar


Language

English en


Organised by

Compliance Trainings (deactivated)

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