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Medical Device Complaint Handling- 2 day In person Seminar complaint definition iso

We Train Healthcare Professionals support@ My Cart 0 items Sign In | Sign Up +1-800-385-1607 +1-800-385-1607 Toggle navigation Home About Us Webinars Webinar Pack Categories Resource Directory Advanced Search 2-day In-person Seminar Medical Device Complaint Handling By Dan O'Leary
Location: Baltimore, MD   Date: April 28th & 29th, 2016   Time:   9:00 AM to 6:00 PM PST    |     Venue : Hilton Garden Inn - Baltimore Inner Harbor Home Agenda Register Venue Speaker Register for Seminar     For discounts on multiple registrations, contact customer care at +1-800-385-1607     Register Now
Overview:

Does your Complaint Management system provide value to your company? It does if your company handles complaints efficiently and effectively - taking them through the reporting, classification, investigation, corrective action, and design change phases. Your system is effective if it recognizes the requirements to report to regulatory agencies (such as FDA, the EU, and Health Canada) and ensures you make the reports on time.

An integrated system addresses multiple elements:

Designated individuals and their required skill sets Procedures to define the process and standardize work Records to maintain and their prescribed content Reports to file with regulatory agencies and their timeframe

The workshop covers all of these elements and includes checklists to help you integrate them into your QMS.

To help clarify the issues, the workshop includes FDA Warning Letters. These Warning Letters illustrate problems that other companies have had so you can avoid them. The workshop also includes hands-on exercises for practical applications.

Why should you attend:

In this two-day workshop you will understand all the processes and elements in a Quality Management System (QMS) that come to bear on effective Complaint Management. It starts with the definition of a complaint in FDA's Quality System Regulation (QSR) and ISO 13485:2003. (The complaint definitions are not the same.) In these systems a complaint has a specific technical meaning that is significantly different from the colloquial meaning.

Areas Covered in the Session: Complaints can lead to investigations that lead to corrective action. The workshop explains how to investigate complaints and perform corrective action using the elements of your QMS. It helps establish the interfaces between these systems, designate individuals, assign responsibility, and assure the required skill set. A complaint may represent a serious event reportable to regulatory authorizes. The workshop helps you understand the FDA reporting requirements for Medical Device Reports (MDRs) and the corresponding reports for the EU and Health Canada. Each of these systems has different definitions, thresholds, and time frames. The corrective action may lead to design changes. Does the design control system handle these changes? Do you know how to evaluate the change for an updated 510(k)? How does the change affect the UDI? Documenting the change in a Technical File or Design Dossier is very important in the EU. The corrective action may lead to a field action, potentially requiring a report to FDA. However, there are complex exceptions to the reporting requirements that may create a record, but not a report. The workshop will help you understand the requirements, establish regulatory timelines, and implement a compliant approach. In addition, handling field actions in the EU and Canada involves a different regulatory structure. Complaints are an essential element for the post-production evaluation required by an ISO 14971:2007 (EN ISO 14971:2012) quality management system. You will learn how to update the risk management file and take action to reduce risk. Who Will Benefit: All levels of Management for all departments and those who desire a better understanding QA/QC/Compliance/Regulatory Affairs Marketing & Sales & Customer Service Engineering/Technical Services Consultants Operations and Manufacturing Agenda Day One Lecture 1:

The Regulatory Structure

The development of the QMS (QSR & ISO 13485) The current versions of the QMS (US, EU, & Canada) Records and their content Reports to regulatory agencies (content, trigger, and timing) FDA Inspections and the guiding documents Quality System Inspection Technique Compliance Program 7382.845 Inspection of Medical Device Manufacturers Exercise - FDA Inspection Levels Exercise - QSIT sampling plans for records Lecture 2:

Unique Device Identification

An overview of UDI Recording and Reporting UDI Complaints Servicing MDRs International Implications Lecture 3:

Servicing

Definition of servicing Relationship to other QMS elements Service Records and Service Reports Service Record analysis (some tools and techniques) Exercise - Analyze a small set of service records using quality tools Lecture 4:

Complaints

Definition of a complaint QSR vs. ISO 13485 definitions Establishing the complaint files Designating individuals Complaint system interrelationships Complaints & CA&PA Complaints & MDRs Complaints and Risk Management (ISO 14971:2007) Complaint system flowchart Complaint records Exercise - Analyze customer reports to determine if they are a complaint and potentially reportable Lecture 5:

Medical Device Reports (US)

Criteria for reporting Establishing the MDR event files Designating individuals MDR system interrelationships MDRs & Complaints Types of MDRs (30 day & 5 day) Reporting MDRs The eMDR System Records required for the MDR system Exercise - Initiate a Medical Device Report Day Two Lecture 6:

Medical device reports in the EU and Canada

Criteria for reporting The regulatory structure in the EU (MDD and MedDev) The regulatory structure in Canada Role of the Notified Body Role of the MDD Authorized Representative Exercise - Analyze an adverse event to determine when to report and when Lecture 7:

Corrective and Preventive Action (CA&PA)

Definitions QSR definitions ISO 9000:2005 definitions The difference between corrective action (CA) and preventive action (PA) CA&PA Interrelationships The CA&PA flowchart CA&PA verification and validation CA&PA effectiveness review CA&PA records Complaint analysis (some tools and techniques) Exercise - Analyze complaints as quality data to identify quality problems Lecture 8:

Design Changes

Understand the role of change in the design control system Design Change interrelationships The Design Change flow chart Design change records Linking design changes to process changes Design change records Exercise - Classify a changes as a design change or a production process change Lecture 9:

510(k) Changes

When a design change requires a pre-market notification change 510(k) change process Interrelationships Design change Risk Management Process 510(k) change records and reports The FDA guidance document Exercise - Analyze design changes to determine if they require a 510(k) Lecture 10:

Risk Management

The definition of risk Determining acceptable risk Establishing the Risk Management File Collecting production and post-production information Evaluating and acting on information Linking risk evaluation to design changes Exercise - Evaluate post-production information for changes to risk Lecture 11:

Corrections and Removals (C&R)

Defining the terms C&R Interrelationships CA&PA Design changes Enhancements C&R records and reports Linkage to recalls Exercise - Evaluate proposed field actions to det qzeivujt. moncler jacket mens blackermine if they are a correction or a removal
Pricing/Register
Want to register by P.O/Check? We facilitate registration by P.O/Checks! Complete your registration in just few easy steps: Please just download, fill out the registration form and send it to us either by email to support@ or just fax us at 302 288 6884. Once the form is received and invoice will be generated and sent back to your fax number. Following this just send us your purchase order by fax at 302 288 6884 Click here to download Registration form
In case you wish to register by using check, please make a check to NetZealous LLC DBA MentorHealth.com and mail it to the below address. NetZealous LLC, DBA MentorHealth, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Phone: +1-800-385-1607 Seminar Pricing Includes (With stay) Google Nexus 7 Tablet 2 Days' Stay Pick-up and Drop Facility (Nearest Airport) Breakfast and Lunch High Tea Pack of 3 Past Webinars on similar subject Group participations Get fabulous discounts by participating in groups of two or more. Send two attendees: Get a discount of 10%! Send three to six attendees: Get a grand discount of 20%! Send seven to 10 attendees: Get a great discount of 25%! Send more than 10 attendees: Get a whopping discount of 30%! To avail the above group discounts, all the participants should register by making a single payment Call our representative TODAY on +1-800-385-1607 to have your seats confirmed! Quick Contact Toll free: +1-800-385-1607 Email: support@ Want to register by Wire Transfer? Please call any of our representatives on +1-800-385-1607 to help you completed the transfer. Venue Location: Baltimore, MD Hotel: Hilton Garden Inn - Baltimore Inner Harbor   625 South President Street Baltimore MD 21202
Speaker Dan O'Leary President, Ombu Enterprises p>Dan 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.


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complaint definition legal Home Quality Manual Procedures Internal Audit Procedure Corrective Action Procedure Control of Nonconforming Outputs Procedure Documented Information Control Procedure Standard Requirement ISO 9001 (Clause-by-clause) ISO 9001:2015 Standard Requirement Annex A ISO 9000:2015 (Fundamental and Vocabolary) ISO 9001:2015 Summary ISO 9001 info Main Changes Transition to ISO 9001:2015 New element: Risks and Opportunities Commercial Consultancy Services Packages Order Form Tuesday, October 6, 2015 Complaint Posted by Integrated Safety Inspection System on 12:46 AM with 1 comment Complaint In the context of ISO 9001, a complaint refers to an expression of dissatisfaction with a product or service and is filed by a customer and received by an organization. Whenever a customer lodges a complaint, a response is either explicitly or implicitly required. Email This BlogThis! Share to Twitter Share to Facebook Categories: Term & Definition Newer Post Older Post Home 1 comment: Zepharia Andres July 14, 2016 at 12:57 AM The future rewards those who press on. I don't have time to feel sorry for myself. I don't have time to complain. I'm going to press on. See the link below for more info. #complain www.ufgop.org

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Subscribe to: Post Comments (Atom) Search Recent Posts Categories 10. Improvement 4. Context of Organization 5. Leadership 6. Planning 7. Support 8. Operation 9. Performance Evaluation consultancy services Continual Improvement Documented Information info information Interested Party Procedure Quality Manual Quality Objective Quality Policy Regulatory Requirement review Risk Risk-based thinking standard Term & Definition Top Management Traceability Verification & Validation Sample Text Blog Archive ►  2016 (2) ►  May (1) ►  January (1) ▼  2015 (152) ►  November (11) ▼  October (141) Verification Validation Traceability Top management System Supplier Strategy Statutory requirement Service Risk-based thinking Risk Review Requirement Release Regulatory requirement Quality policy Quality objective Quality management system Quality management Quality Provider Product Process-based quality management system Process approach Process Policy Performance indicator Performance Outsource Output Organization Objective evidence Objective audit evidence Objective Object Nonconformity Monitoring Measuring equipment Measurement Management system Management Knowledge Involvement Interested party Innovation Infrastructure Information system Information Improvement Function Feedback Effectiveness Documented information Determination Design and development Defect Data Customer satisfaction Customer Corrective action Correction Contract Continual improvement Context of the organization Conformity Concession Complaint Competence Characteristic Audit program Audit findings Audit Evidence Audit Criteria Audit ISO 9000:2015 Quality management systems — Fundame... Quality Manual ISO 9001:2015 Summary 10.3 Continual improvement 10.2 Nonconformity and corrective action (10.2.2) 10.2 Nonconformity and corrective action (10.2.1) 10.1 General improvement 9.3 Management Review (9.3.3) 9.3 Management Review (9.3.2) 9.3 Management Review (9.3.1) 9.2 Internal Audit (9.2.2) 9.2 Internal Audit (9.2.1) 9.1 Monitoring, measurement, analysis and evaluati... 9.1 Monitoring, measurement, analysis and evaluati... 9.1 Monitoring, measurement, analysis and evaluati... 8.7 Control of nonconforming outputs (8.7.2) 8.7 Control of nonconforming outputs (8.7.1) 8.6 Release of products and services 8.5 Production and service Provision (8.5.6) 8.5 Production and service Provision (8.5.5) 8.5 Production and service Provision (8.5.4) 8.5 Production and service Provision (8.5.3) 8.5 Production and service Provision (8.5.2) 7.1 Resources (7.1.6) 8.5 Production and service Provision (8.5.1) 8.4 Control of externally provided processes, prod... Powered by Blogger. About Me Integrated Safety Inspection System View my complete profile

Home Quality Manual Procedures Internal Audit Procedure Corrective Action Procedure Control of Nonconforming Outputs Procedure Documented Information Control Procedure Standard Requirement ISO 9001 (Clause-by-clause) ISO 9001:2015 Standard Requirement Annex A ISO 9000:2015 (Fundamental and Vocabolary) ISO 9001:2015 Summary ISO 9001 info Main Changes Transition to ISO 9001:2015 New element: Risks and Opportunities Commercial Consultancy Services Packages Order Form Tuesday, October 6, 2015 Complaint Posted by Integrated Safety Inspection System on 12:46 AM with 1 comment Complaint In the context of ISO 9001, a complaint refers to an expression of dissatisfaction with a product or service and is filed by a customer and received by an organization. Whenever a customer lodges a complaint, a response is either explicitly or implicitly required. Email This BlogThis! Share to Twitter Share to Facebook Categories: Term & Definition Newer Post Older Post Home 1 comment: Zepharia Andres July 14, 2016 at 12:57 AM The future rewards those who press on. I don't have time to feel sorry for myself. I don't have time to complain. I'm going to press on. See the link below for more info. #complain www.ufgop.org

Reply Delete Add comment Load more...

Subscribe to: Post Comments (Atom) Search Recent Posts Categories 10. Improvement 4. Context of Organization 5. Leadership 6. Planning 7. Support 8. Operation 9. Performance Evaluation consultancy services Continual Improvement Documented Information info information Interested Party Procedure Quality Manual Quality Objective Quality Policy Regulatory Requirement review Risk Risk-based thinking standard Term & Definition Top Management Traceability Verification & Validation Sample Text Blog Archive ►  2016 (2) ►  May (1) ►  January (1) ▼  2015 (152) ►  November (11) ▼  October (141) Verification Validation Traceability Top management System Supplier Strategy Statutory requirement Service Risk-based thinking Risk Review Requirement Release Regulatory requirement Quality policy Quality objective Quality management system Quality management Quality Provider Product Process-based quality management system Process approach Process Policy Performance indicator Performance Outsource Output Organization Objective evidence Objective audit evidence Objective Object Nonconformity Monitoring Measuring equipment Measurement Management system Management Knowledge Involvement Interested party Innovation Infrastructure Information system Information Improvement Function Feedback Effectiveness Documented information Determination Design and development Defect Data Customer satisfaction Customer Corrective action Correction Contract Continual improvement Context of the organization Conformity Concession Complaint Competence Characteristic Audit program Audit findings Audit Evidence Audit Criteria Audit ISO 9000:2015 Quality management systems — Fundame... Quality Manual ISO 9001:2015 Summary 10.3 Continual improvement 10.2 Nonconformity and corrective action (10.2.2) 10.2 Nonconformity and corrective action (10.2.1) 10.1 General improvement 9.3 Management Review (9.3.3) 9.3 Management Review (9.3.2) 9.3 Management Review (9.3.1) 9.2 Internal Audit (9.2.2) 9.2 Internal Audit (9.2.1) 9.1 Monitoring, measurement, analysis and evaluati... 9.1 Monitoring, measurement, analysis and evaluati... 9.1 Monitoring, measurement, analysis and evaluati... 8.7 Control of nonconforming outputs (8.7.2) 8.7 Control of nonconforming outputs (8.7.1) 8.6 Release of products and services 8.5 Production and service Provision (8.5.6) 8.5 Production and service Provision (8.5.5) 8.5 Production and service Provision (8.5.4) 8.5 Production and service Provision (8.5.3) 8.5 Production and service Provision (8.5.2) 7.1 Resources (7.1.6) 8.5 Production and service Provision (8.5.1) 8.4 Control of externally provided processes, prod... Powered by Blogger. About Me Integrated Safety Inspection System View my complete profile