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Effective Complaint Handling, Medical Device Reporting and Recalls 2017

Start Date:
Thursday, 9 March, 2017
End Date:
Friday, 10 March, 2017 6:00pm
Pain Management, Psychiatry, Infectious Disease, Internal Medicine, Emergency Medicine, Hematology, Pulmonary Medicine, Physical Medicine

Overview: An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences.

Complaints cannot be ignored. They are an excellent indicator of problems with the use, design, and/or manufacture of a product. A single complaint that is thoroughly investigated may lead a company to take remedial or corrective action. It may also take an ongoing analysis of numerous complaints before a trend is spotted that causes a company to initiate changes in their product, labeling, packaging or distribution.

The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as overview of best practices for timely and effective investigations. Trending is the only way a company can stay on top of emerging quality issues and address those that are most pressing.Medical Device Reporting (MDR) is the mechanism for FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly.

User Facilities (e.g., hospitals, nursing homes) are required to report suspected medical device related deaths to both the FDA and the manufacturers. User facilities report medical device related serious injuries only to the manufacturer. If the medical device manufacturer is unknown, the serious injury is reported by the facility to FDA. Health professionals within a user-facility should familiarize themselves with their institution procedures for reporting adverse events to the FDA.The MDR process impacts device user facilities, manufacturers, importers, and distributors.

If you are a device user facility, you must report deaths and serious injuries that a device has or may have caused or contributed to, establish and maintain adverse event files, and submit summary annual reports. If you are a manufacturer or importer, you must report deaths and serious injuries that your device has or may have caused or contributed to, you must report certain device malfunctions, and you must establish and maintain adverse event files.

If you are a manufacturer, you must also submit specified follow-up.Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.A medical device recall does not always mean that you must stop using the product or return it to the company.

A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, a pacemaker or an artificial hip) is recalled, it does not always have to be removed. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place.

FDA classifies medical device recalls into three categories, representing the potential risk to public health: Class I, II, and III.Why should you attend?Understand that although FDA does not specify a standard complaint handling system, the requirements do specify certain actions that shall be included in any systemGrasp and comprehend the definitions and elements of the regulatory requirements for Complaint Handling, Medical Device Reporting and handling of RecallsAll personnel who deal with customers, or who may receive a complaint call, must be trained in the proper routing/handling of complaintsProvide information about FDA's Medical Device Reporting (MDR) regulation and the Voluntary Reporting program called MedWatchIntroduce you Medical Device Reporting and to help you better understand the process and benefits of Voluntary Reporting and responsibilitiesLatest Amendments to the MDR Regulation to Implement FDAMA ChangesTo Recall or Not to Recall: Issues to consider regarding whether a Field Action is requiredDetermine when a recall is required and how to manage a recall, who must report, when to report, what to report, where to report, recordkeeping requirements, FDA regulatory authority, references and guidanceSeminar attendees are encouraged to bring examples of their work from the functional area on the various topics as applicable for group discussionReview and discuss pain points, challenges and solutionsAreas Covered in the Session:Reporting complaintsManagersComplaint evaluation and investigationData collection and trendingCAPA process for investigating complaintsAccelerate complaints recording, investigation, reporting, escalation/triggers and closure cycle as cases are automatically routed from one stage to the nextGain enterprise-wide visibility into the complaints data and track the process with performance metrics, dashboards or other indicatorsImprove communication and teamwork on complaints across departments and functional areasDrive continuous improvement by tying corrective actions with complaints for a closed loop quality processImprove management of the complaint lifecycle with real-time trending and escalation of customer complaintsUnderstand the History of MDR RegulationWhat types of Reports does the FDA receive and who must submit Mandatory Reports to the FDA?Who can submit Voluntary Reports to the FDA?How Does the FDA Use Medical Device Reports?What are the exemptions, variances, or alternative forms of adverse event reporting requirements?Basics of a Recall: Initiation, Classification and Public WarningMedical Device Recall ReportingRecall Responsibilities & RequirementsFDA's RoleIntroduction to Medical Device Recalls: Industry ResponsibilitiesRecall Communication and StrategyMonitoring and Auditing Recall EffectivenessRecall TerminationGuidance for Industry, Trends and FDA Inspection & Enforcement Statistics and TrendsWho will benefit:Regulatory Affairs ManagementRegulatory Affairs SpecialistAuditorsCompliance OfficerCompliance SpecialistClinical AffairsQuality Assurance ManagementMarketing & SalesDistributors/Authorized RepresentativesLegal CounselEngineering/Technical ServicesOperations/ManufacturingConsultants Agenda:Day 1 ScheduleLecture 1:Complaint HandlingWhat are the elements of an effective complaint managementsystem?How does risk management influence complaint handlingdecisions?What are the responsibilities of other departments?What is the best way to train customer contact employees?What steps would the FDA expect to see the departments taking that sorts out potential MDRs, product complaints and other reportable events?What and how do you perform trending?What are examples of how companies trend and analyze service calls and product complaints?Understand how and why CAPA is tied in to product complaint investigationWhat is an appropriate complaint handling system in a risk-based post-market environment?How do you audit a complaint handling system?From your audits, how do you judge that your complaint handling system is effective?Assignment of responsibilityManufacturer should develop a method for maintaining records of complaints and investigations that: is functional and economical, meets company needs, and meets FDA requirements and expectationsIdentify designated complaint handling unitInstructions for documenting complaint informationProcess for evaluating complaintsProcess for investigating complaintsIdentify and process MDR'sHow to process customer returnsRecords and trend analysisComplaint closureExamples of tools currently being used to conduct investigationsHow far and in-depth do you go with your investigationsWhat are current FDA "hot" buttons and trends, benchmarks and best practices for investigationsHow to become a "good" investigator and the emphasis on closed-loop investigationsWritten Procedures: Designated Complaint Handling Unit, Training and RecordsRecent Enforcement ActionsLecture 2:Medical Device ReportingIntroduction to Medical Device ReportingWhat are the key terms, definitions and forms?MDR procedures and processesWhat are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?How do you manage international reporting requirements under your complaint handling system?Consider the relationship between MDRs and Risk AssessmentsLecture 3:Exercise and Recap of Day 1Exercise on Product Complaints/Complaint HandlingQuizDay 2 ScheduleLecture 1:Medical Device ReportingeMDR Electronic Medical Device ReportingHow to Report a ProblemEvent Problem Codes and Manufacturer Evaluation CodesMedWatch: Safety Information and AER ProgramCompleting Form FDA 3500AWhat form should I use to submit reports of individual adverse events and where do I obtain these forms?Where and how do I submit reports and additional information?Does the information in my report constitute an admission that the device caused or contributed to the reportable event?What are the requirements for developing, maintaining, and implementing written MDR procedures and maintain records/files that apply to me?Requirements for Individual Adverse Event ReportsUser Facility Reporting, Importer Reporting and Manufacturer Reporting RequirementsLecture 2:RecallsWhat happens in a medical device recall: Firm-initiated recall vs. mandatory recallWhat information needs to be reported?What types of records do companies need to keep?Prior to notifying FDA, what steps should you have taken?What are the dos and don'ts when informing FDA of a product problem?Who should be involved in the decision process?Who should be responsible for communicating with FDA?What are the consequences of a recall?What factors should you consider when determining whether or not to get your product back?How do you prepare for a post recall inspection?What customer and other outside communications are necessary?What documentation should be prepared?How should the product liability implications of recall communications be handled?What is an effectiveness check?Health Hazard Evaluations are conducted by FDAHow should you write your recall correspondence?How do you determine that your recall is completed and what do you do to close your recall internally and with FDA?Create and use a recall operationalUnderstand what is required for the recall strategy as expected by FDADepth of recall and using a viable, sustainable and effective strategyUnderstand why the documentation and paper trail are so critical and termination of a recallDiscuss most recent recalls not only for devices but pharmaceuticals and why the numbers are alarmingLecture 3:Exercise and Recap of Day 2Exercise - MDR and RecallQuizSpeaker: David R.

DillsRegulatory Affairs & Compliance Consultant, David R. Dills, Global Regulatory Affairs & Compliance Consultant, has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVDs, and bio/pharmaceutical manufacturers on the global landscape. Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA, Design Dossiers, Technical Files, CMC, NDA, and IDE submissions, currently serves as a U.S.

Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides regulatory submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification. His background encompasses broad capabilities in regulatory and compliance oversight and governance, including CAPA, Design Controls, Validation, Software Quality with regulatory oversight, FDA Mock Inspections, remediating documentation management systems, Supplier Quality, Adverse Event Reporting, Product Complaints, GxP Training, interpretation and applicability of FDA and international regulations and standards, postmarketing surveillance, ISO 13485 and CE Mark, Medical Device/IVD/Active Implantable Directives.

Mr. Dills leads and manages efforts involving multi-country product registrations and licensing in Asia Pacific, EMEA and The Americas from premarketing to postmarketing, and works with the Regulatory Authorities and strives to provide consistent, practical compliance solutions that work with reduction of regulatory compliance risk. Location: San Diego, CA Date: March 9th & 10th, 2017 and Time: 9:00 AM to 6:00 PM Venue: Four Points By Sheraton San Diego DowntownAddress: 1617 1st Avenue - San Diego, California, 92101 - United StatesPrice: Price: $1,295.00 (Seminar Fee for One Delegate)Until February 10, Early Bird Price: $1,295.00 from February 11 to March 07, 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:


Four Points By Sheraton San Diego Downtown 1617 1st Avenue - San Diego,
92101 - United States

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Conference organized by NetZealous DBA as GlobalCompliancePanel

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