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Event

Webinar On FDA

Manufacturers and importers must report adverse events associated with a risk to health or death. Until now, the reports were submitted in hardcopy using MedWatch form 3500A.

Description : With the changes in operational parameters for MDRs, firms need to adjust their reporting program to ensure they provide adequate time to make corrections to their coding errors. eMDRs with errors will be rejected and, therefore, deemed “not filed.” This means firms should exam their MDR program to adapt to the strict eMDR requirements. Unless the FDA issues an acknowledgement of receipt for your eMDR, it is not considered filed. The date you submit the eMDR is not relevant. This creates secondary demands on a firm’s MDR program, CAPA program and its Q.A. functions. Firms need to integrate the new procedural requirements for eMDR. When the FDA will start enforcing the new eMDR requirements is not clear. Typically, the FDA will give the industry enough time to make mistakes or reach a point of unquestionable failure. The industry’s problems are predictable. Likewise, the content of eMDR Warning Letters is predictable. Given the number of years firms have had to implement eMDR, excuses will not be persuasive.Firms need to reassess their MDR procedures for information accuracy and coding. Efficiency is equally important. MDR requires the prompt management of “risk to health” information. Such information is critical to the medical device postmarket program and equally loaded as an enforcement issue for failures to meet eMDR requirements. Firms no longer have the option of being on a learning curve. Firms need to be sure that their related postmarket programs are well coordinated with eMDR requirements. Otherwise, they will be facing a tough Q.A. problem.Areas Covered in the Session :MDRs reporting elements forManufacturersImportersUser facilitiesNew eMDR program requirementseSubmitter programHL7 electronic submissionsElectronic Submissions Gateway (ESG) accountOperational deadlineseMDR rejectionsRevisions to related postmarket programsQuality Assurance coverageTrainingCorrective and Preventive ActionsEnforcementWho Will Benefit:Device manufacturersDevice importersUser facilitiesFDA consultantsDomestic and international regulatory affairs managersQ.A. managers / trainingComplaint and MDR managersData processing managers3rd party complaint managersFor more information and enquiries contact us atCompliance Trainings5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada  Customer Support : #416-915-4458 

When

13 Jul 2015 @ 01:00 pm

13 Jul 2015 @ 02:00 pm

Duration: 1 hours

Timezone: GMT -5:00


Where

Online Webinar


Language

Englishen


Organised by

FutureCorp Consulting (deactivated)

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