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Webinar on Quality System Regulations (QSRs) for Medical Devices and IVDs

This webinar will address the said current good manufacturing practice (cGMP) requirements to help you stay in conformity with 21 CFR Part 820 (QSR).

FDA states in warning letters “This inspection revealed that these devices are adulterated within the meaning of section 510(h) of the FD&C Act, in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the 21 CFR Part 820…”. This webinar will address the said current good manufacturing practice (cGMP) requirements to help you stay in conformity with 21 CFR Part 820 (QSR).Accurate understanding and interpretation of cGMP requirements found at 21 CFR Part 820 can significantly contribute to achieving compliance fast, resulting in saving significant amount of time and efforts and bringing innovative medical products to the market faster.This webinar is intended to help you get familiar with FDA’s Quality System Regulations (cGMP) for medical devices including in vitro diagnostic medical devices. This webinar is further intended to provide guidance on the best practices for implementing 21 CFR Part 820 (QSRs), which helps assure that medical devices are safe and effective for their intended use.This 60-min webinar will help you ensure if you engage in the best practices for establishing and maintaining quality management systems necessary to achieve compliance and to remain compliant with 21 CFR Part 820 (cGMPs).Areas Covered in the Session:Applicable LawsFDA Quality System RegulationsDefinitionsDesign Control: Design And Development Planning, Design Input, Design Output, Design Review, Design Verification, Design Validation, Design Transfer, And Design ChangesDesign History File (DHF)Quality System Procedures, Purchasing Controls And ServicingInspection, Measuring And Test EquipmentProcess ValidationCorrective And Preventive Action (CAPA) And Complaint FilesQuality Requirements For Premarket Approval (PMA) ApplicationDevice History Record (DHR) And Device Master Record (DMR)Mistakes While Implementing QSRsHow to Avoid MistakesFrequent Citations in 483s and How to AvoidTop 20 Items Cited in 483sLessons Learned:  Best PracticesWho Will Benefit:CEOsVPsCompliance OfficersAttorneysR&D and Manufacturing ManagersManagers (RA, QA/QC, CA)ConsultantsContractors and SubcontractorsPrice tags:LiveSingle Live : For One Participant$ 249Corporate Live : For Max. 10 Participants$ 899RecordingSingle REC : For One Participant - Unlimited Access for 6 Months$ 299For enquiries and more contact usCompliance Trainings5939 Candlebrook Ct,  Mississauga, ON L5V 2V5,  Canada  Customer Support : #416-915-4458 


26 Aug 2014 @ 01:00 pm

26 Aug 2014 @ 02:00 pm

Duration: 1 hours

Timezone: GMT -8:00


Online Webinar

Organised by

Compliance Trainings (deactivated)

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