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Webinar On Establishing an FDA-Compliant UDI System

How to implement the UDI system requirements in a CAC-SI manner

Description :This seminar is intended to help you effectively implement a unique device identification (UDI) system based on the final rules issued and published in federal register. Specifically, new changes in the final rules will be discussed, contributing to saving an enormous amount of time, efforts and resources to achieve compliance and to remain compliant with the final UDI system requirements.Areas Covered in the Session :Applicable Statute(S), Regulations and Enforcement AuthorityDefinitionsUDI Development HistoryUDI Final Rules: Technical Requirements and Changes MadeWhen to Use a UDI and When to Discontinue Its Use, and When to Use a New UDIUDI System Requirements including Technical StandardsRequirements for a Unique Device IdentifierFDA Accreditation Process for an Issuing Agency including Suspension and RevocationUDI Rules: Applicability, Exceptions and AlternativesDevices at a Retail Store, Delivered to Health Care Facility, Outpatient Treatment Facility, Nursing Home, Ambulatory Surgical Center, and HospitalsDevices Labeled Prior to Compliance DatesDevices (Single Use, Custom, Intended for Export, Convenience Kits, Combination Products, Medical Procedure Kits and Trays)Class I Devices: cGMPs ExemptedWhen to Request Exceptions and ModificationsWhich Devices Not Required to Have a Production IdentifierDirect Marking Requirements and Revised ChangesRequirements for Stand-Alone SoftwareCompliance Dates for the Applicable Requirements Over 7 YearsDevice Identifier Formats including DatesGlobal UDI Database (GUDID): Technical Requirements (Data Format and Data Attributes)Impact of the Final Rules to Many Business Areas/ProcessesChanges in Device Design, Documentation and Manufacturing ProcessesPractical, Actionable, and Sustainable Strategy: Good Practices to Implement UDI Systems FastConclusionWho Will Benefit:R&D Scientists, Managers, Directors, and VPsRegulatory Affairs and Compliance ProfessionalsClinical Affairs ProfessionalsQuality ProfessionalsConsultantsLegal and Compliance OfficersMarketing ProfessionalsSenior ManagementAnyone Interested in the Subject


5 Oct 2015 @ 01:00 pm

5 Oct 2015 @ 02:00 pm

Duration: 1 hours

Timezone: GMT -5:00


Online Webinar

Organised by

FutureCorp Consulting (deactivated)

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