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Implementing ISO 13485:2016- 2017 by Dan O'Leary

Start Date:
Thursday, 27 April, 2017
End Date:
Friday, 28 April, 2017 6:00pm
Pain Management, Endocrinology, Internal Medicine, Emergency Medicine, Critical Care, Headache / Migraine, Orthopedic Surgery, Health & Nutrition

Overview:The final version of ISO 13485:2016 is now available and companies should be planning their implementation. There are significant changes from the earlier version; they will require major modifications to the Quality Management System (QMS). The new version has better alignment with FDA's QSR, but there are still major differences that create issues for effective QMS implementation.This workshop covers the differences from the 2003 version to the 2016 version and offers practical implementation advice to update your QMS.

Participants will also learn the differences with QSR and understand how to resolve them. The workshop uses extensive examples and exercises to help clarify the concerns.Some regulatory systems will rely on ISO 13485:2016 through the Medical Device Single Audit Program (MDSAP). The US will participate in MDSAP, but doesn't expect to change its regulations. The EU is not participating, has published its own version, EN ISO 13485:2016, and will continue with the Notified Body system.

However, the EU intends to replace the directives with new regulations resulting in new versions of EN ISO 13485:2016 and EN ISO 14971:2012.The workshop covers implications in particular regulatory systems including MDASP and its nonconformity grading system. Why should you attend :The transition to ISO 13485:2016 can be complicated and, for some companies, the period is short, depending on when the current certificate expires.

Start planning and implementing as soon as possible. This workshop provides the knowledge and understanding to update your QMS.Workshop Objectives::Participants will learn the major changes in the new version of the standard. In addition, they will understand where the new standard and QSR do not agree. The primary objective is to give participants the understanding needed for an efficient and effective QMS update.Who will benefit:Quality managersManagement RepresentativesQuality engineersQuality assurance and quality controlRegulatory affairs managersRegulatory affairs professionalsR&D managersR&D engineersProduct design and developmentOperations managersProduction managers and supervisorsManufacturing engineersRisk managersComplaint system team membersCAPA team members Agenda:Lecture 1:Overview of ISO 13485:2016Summary of the differences between ISO 13485:2003 and ISO 13485:2016High level comparison with FDA QSRLecture 2:Regulatory FrameworkTransition period for certificatesCanada - MDSAP v CMDCASEN ISO 13485:2016 and the MDDThe new QMS audit findings/nonconformance grading systemImplications of the EU's Medical Device RegulationsLecture 3:Management ResponsibilityQuality Policy and ObjectivesResponsibility and AuthorityInternal Quality AuditsManagement ReviewLecture 4:Resource ManagementCompetence and TrainingInfrastructureWork Environment and Contamination ControlLecture 5:Design and DevelopmentDesign PlanningDesign Inputs and Design OutputsDesign Verification and Design ValidationDesign ReviewDesign TransferDesign ChangesDesign Files Day 2 ScheduleLecture 1:Supplier ManagementSelectionPurchasing InformationWritten Quality AgreementsPurchased Product VerificationLecture 2:Production ProcessesProduction ControlInstallation and ServicingIdentification and TraceabilityControl of Nonconforming ProductLecture 3:Process ValidationWhen to ValidateValidation RequirementsSoftware ValidationLecture 4:Monitoring and MeasuringControl of EquipmentProcesses and ProductsData AnalysisComplaint HandlingLecture 5:Corrective and Preventive ActionCorrective ActionPreventive ActionSpeaker:Dan O'Leary,President, Ombu Enterprises, Dan O'Leary is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management.

Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management. Location: Raleigh, NC Date: April 27th & 28th, 2017 and Time: 9:00 AM to 6:00 PM Venue: Courtyard Raleigh-Durham AirportAddress: 2001 Hospitality Ct, Morrisville, NC 27560, United States Price: Register now and save $200. (Early Bird) Price: $1,295.00 (Seminar Fee for One Delegate) Until March 20, Early Bird Price: $1,295.00 From March 21 to April 25, Regular Price: $1,495.00Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Quick Contact:NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407Fax: 302-288-6884Email: Follow us on LinkedIn: us our Facebook page: us on Twitter:


Courtyard Raleigh-Durham Airport 2001 Hospitality Ct,
North Carolina,
United States

Organizer Details

Conference organized by NetZealous DBA as GlobalCompliancePanel

NetZealous LLC-globalcompliancepanel, 161 Mission Falls Lane, Suite 216, Fremont,CA94539, USA
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