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Webinar On FDA Inspection Preparation and Readiness

The Top 20 Most Common GMP Deficiencies for Device Manufacturers

Description : This webinar is intended to discuss FDA inspection practices and the most common deficiencies for medical device manufacturers including in vitro diagnostic device manufacturers. This presentation is further intended to help you prepare for and manage an FDA inspection in a proactive and effective manner. The top twenty (20) common deficiencies are based on the speaker’s analysis of 483s issued for the past seven (8) years.Areas Covered in the Session :Applicable Laws and RegulationFDA Manuals and Inspection GuidesHosting an FDA InspectionField Management DirectivesInspection Types and CategoriesInspection ClassificationFDA Forms 482 and 483Top Twenty (20) Most Common Deficiencies During FDA Inspections for Device ManufacturersHow to Identify Gaps between FDA Expectations and Firms’ Current Level of ComplianceWhat/How to Prepare for and Manage an FDA InspectionHow to Communicate Before, During and After inspection: Dos and Don’tsCommon Mistakes and How to Prevent ThemHow to Most Effectively Use Close Out MeetingResponding to 483s, If IssuedHow to Communicate with Emotional IntelligenceEmployee TrainingActual FDA Inspection Case Studies (Reports)Speaker’s PASS-IT Suggestions/RecommendationsConclusionWho Will Benefit:Quality AssuranceManufacturingRegulatory AffairsResearch & DevelopmentClinical AffairsSenior ManagementConsultantsContractorsCompliance OfficersAnyone Interested in the FDA InspectionPrice 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

19 Mar 2015 @ 01:00 pm

19 Mar 2015 @ 02:00 pm

Duration: 1 hours

Timezone: GMT -5:00


Where

Online Webinar


Organised by

Compliance Trainings (deactivated)

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