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Quality Audits for the Medical Device Industry

Quality audits are an important element in checking the health of a Quality Management System (QMS). Audits are one of the most powerful tools that management has to assure on effective QMS.

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Quality Audits for the Medical Device Industry

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  1. Global CompliancePanel Knowledge,aWayForward… 2-day In-person Seminar: QualityAuditsfortheMedicalDeviceIndustry Course "Quality Audits for the Medical Device Industry" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. About GlobalCompliancePanel: GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory &compliancetrainings.Thesetrainingsaresimplewhilebeingrelevantandcost-effectivewhilebeingconvenient.GlobalCompliancePanelimpartsknowledgeofbestpracticesacrossabroadrangeofuser-friendly mediums such as webinars, seminars, conferences and tailored, individualizedconsulting.Thesehelporganizationsandprofessionalsimplementcomplianceprogramsthatmeetregulatorydemandsandputbusinessprocessesinplace.Throughourtrainings,webringtogethertheregulatorsorexpertsonregulationontheonehand,withthecommunitythatneedstolearnorbeawareofthoseregulations,ontheother. OurservicesbenefittheMedicalDevices,Pharmaceutical,BioTechnology,FoodSafety,FinancialAccountingStandards,andITControl&PCIIndustries.OurclienteleincludescompaniessuchasJ&J,Pfizer,SanofiAventis,PallCorp, Abbott,Merck,Bayer,andRoche,someofwhichareFortune500companies. ProfessionalswhoundergotrainingsfromGlobalCompliancePanelexhibitavastlyimprovedqualityoflifeinwhichthereisincreasedproductivityandprofessionalgrowth.Some30,000professionalshavegainedfrommorethan500trainingcourseswehaveconductedtillnow All rights are reserved © GlobalCompliancePanel.

  2. 2-dayIn-personSeminar2014 Global CompliancePanel • Overview: • Quality audits are an important element in checking the health of a Quality Management System (QMS).Audits are one of the most powerful tools that management has to assure on effective QMS. • When you read an FDAWarning Letter do you ask, "Where was the internal audit program?" Why didn't the company find it • themselves? • In this seminar participants will look at the various kinds of audits and understand their role. Internal quality audits (1st party) help a company evaluate itself. Customer/supplier audits (2nd party) play a role in an effective supplier management pro- gram. Don't forget that you could be the supplier being audited. Independent audits (3rd party) can help provide assurance about the health of a QMS. • Who will benefit: • The seminar provides valuable assistance to device manufacturers in establishing an effective quality audit program.The employees who benefit include: • Senior and middle management • Management Representative • QualityAssurance • Quality Engineers • RegulatoryAffairs • Supplier Management and Purchasing • Supplier Quality Engineers • LeadAuditors • AuditTeam Members • Agenda: Day 1: Day 2: • Lecture 1:Audit requirements in QMS standards • FDA QSR • ISO 13485:2003 • ISO 9001:2008 Lecture 8:Conducting Second Party Audits Lecture 9:Being Audited (2nd and 3rd party) Lecture 10:Responding to audit nonconforma - nces Lecture 2:Setting up the audit program Lecture 3:Auditor Qualifications Lecture 11:Reporting to Management Review Lecture 4:Planning the Audit Lecture 5:Conducting the AuditLecture 6:Audit Sampling PlansLecture 7:Reporting the Audit All rights are reserved © GlobalCompliancePanel.

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