18 complaints, adverse event reporting, and recalls an integrated approach

GlobalCompliancePanelKnowledge, a Way Forward…2-day In-person Seminar:Complaints, Adverse Event Reporting, and Recalls An Integrated Approach Price San Diego, CA…
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GlobalCompliancePanelKnowledge, a Way Forward…2-day In-person Seminar:Complaints, Adverse Event Reporting, and Recalls An Integrated Approach Price San Diego, CA Price:October 26th & 27th, 2017$1,295.00(Seminar for One Delegate)9:00 AM to 6:00 PM Register now and save $200. (Early Bird)Register for 5 attendeesDan O'Leary President, Ombu EnterprisesPrice: $3,885.00 $6,475.00You Save: $2,590.0 (40%)*Dan O'Leary is 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 certified by APICS in Resource Management.Overview : Medical Device manufacturers operate in numerous regulatory systems that often have different requirements and are not always consistent. The new ISO 13485:2016 emphasizes this problem. Manufacturers must identify their roles, identify the regulatory requirements for that role, and incorporate them into the quality management system. The various jurisdictions, however, deal with post-market device issues in many different ways. The quality management system, QMS, needs three interlocking process: complaint management, adverse event reporting, and recalls. These processes also have supporting QMS processes such as corrective action and design changes.**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.GlobalCompliancePanel2-day In-person Seminar:Complaints, Adverse Event Reporting, and Recalls An Integrated ApproachAgenda: Day OneDay TwoLecture 1: The Regulatory StructureLecture 1: Risk Management FDA QSR ISO 14971:2007 and regional variants ISO 13485:2016 and regional variants Incorporating post-market information ISO 14971:2007 and regional variants  Implementing MDSAP  The EU Medical Device RegulationLecture 2: Servicing  Identification of problemsLecture 2: Updating Pre-market Submissions  US - The 510(k) guidance  EU - Technical files and design dossiers  Canada - License changes Servicing data analysis  Input to the complaint processLecture 3: Adverse Event Reporting  US - MDRLecture 3: Complaints  Identifying complaints EU - Vigilance Reports  Canada - Mandatory Problem Reporting Evaluating complaints  Investigating complaintsLecture 4: Recalls Complaint data analysis US - Corrections and Removals Input to the corrective action process EU - Field Safety Corrective Actions Input to the risk management process Canada - RecallLecture 4: Corrective Action  Developing the processWho will benefit: Analyzing product and process information Quality Directors and Managers Determining subsequent actions Regulatory Directors and Managers Input to the design process  Input to the risk management process Design Engineering Managers  Sustaining Engineering ManagersLecture 4: Design and Design Changes Risk Managers Determining the need for a design change Complaint Specialists Documenting design changes Adverse Event Reporters Design change verification and validation Corrective Action Specialists Input to the risk management process  Input to the pre-market submission process Recall Specialists2-day In-person Seminar:GlobalCompliancePanelComplaints, Adverse Event Reporting, and Recalls An Integrated ApproachWhat You will getGroup Participation10%2 Attendees to get offer20%3 to 6 Attendees to get offer25% 30%1Learning Objectives2Participation certiďŹ cates3Interactive sessions with the US expert4Post event email assistance to your queries.5Special price on future purchase of web7 to 10 Attendees to get offer 10+ Attendees to get offerPayment Optionbased trainings.1Credit Card: Use the Link to make Payment by Visa/Master/American Express card click on the register now link6Special price on future consulting or expertise services.2Check: Kindly make the check payable to NetZealous DBA GlobalCompliancePanel and mailed to 161 Mission Falls Lane, Suite 216,7GlobalCompliancePanel.Fremont, CA 94539, USA3PO: Please drop an email to or call the4Special price on future seminars by8Seminar Kit – includes presentation handout,our toll free +1-800-447-9407 for the invoice andID card, brochure, trainings catalog, notepadyou may fax the PO to 302 288 6884and pen.Wire Transfer: Please drop an email to or call our toll free +1-800-447-9407 for the wire transfer9Networking with industry's top notch professionalsinformationContact Information: Event Coordinator 161 Mission Falls Lane, Suite 216,Kindly get in touch with us for any help or information.Fremont, CA 94539, USALook forward to meeting you at the seminarNetZealous LLC, DBA GlobalCompliancePanelToll free: +1-800-447-9407 Fax: 302 288 6884 Email: support@globalcompliancepanel.comwww.globalcompliancepanel.comGlobalCompliancePanel
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