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Online Webinar
28 Jul 2015
Science

Webinar On FDA Inspection and Medical Device Design Control

This webinar is intended to provide guidance on understanding, interpreting, and implementing design control procedures in a way to survive an FDA inspection

Description : This webinar is intended to provide guidance on understanding, interpreting, and implementing design control procedures in a way to survive an FDA inspection. This presentation is further intended to help you establish and maintain adequate design control procedures for all classes of medical devices including IVDs. In particular, this webinar will address how to best prepare for an FDA inspection concerning design control using real case examples.This 60-min presentation will provide great opportunities to get familiar with design control requirements and the FDA inspection concerning design control systems applicable to all types of medical devices including IVDs.This webinar is a must for medical device and IVD firms including anyone interested in the topics from other industry.Areas Covered in the Session :Applicable Laws and RegulationsDefinitionsDesign Control RequirementsDesign and Development PlanningDesign Input and Design OutputDesign ReviewDesign Verification And ValidationDesign Transfer and Design ChangesDesign History File (DHF), Device History Record (DHR) and Device Master Record (DMR)FDA Inspection for Design ControlCommon Mistakes and How to AvoidHow to Prepare for FDA inspection for Design ControlBest Practices for Establishing and Maintaining a Design Control SystemSpeaker’s Recommendation and Suggestions on PASS-IT SolutionsWho Will Benefit:R&DQualityRegulatory AffairsCompliance OfficersCEOsVPsAttorneysComplainant ManagersManagers (RA, QA/QC, CA)ConsultantsContractors and SubcontractorsAnyone interested in the topicFor more information and enquiries contact us atCompliance Trainings5939 Candlebrook Ct, Mississauga, ON L5V 2V5, CanadaCustomer Support : #416-915-4458 

When

28 Jul 2015 @ 01:00 pm

28 Jul 2015 @ 02:00 pm

Duration: 1 hours

Timezone: GMT -5:00


Where

Online Webinar


Language

English en


Organised by

FutureCorp Consulting (deactivated)

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