2-day In-person seminar on Effective Complaint Handling, Medical Device Reporting and Recalls at Phoenix AZ Shared by globalcompliancepanel
An effective complaint handling system is an extremely importantpart of any quality system. Manufacturers should understand that any complaintreceived on a product shall be evaluated and, if necessary, thoroughlyinvestigated and analyzed, and corrective action shall be taken. The results ofthis evaluation should lead to a conclusion regarding whether the complaint wasvalid, what the root cause of the complaint was, and what action is necessaryto prevent further occurrences. Complaints cannot be ignored. They are anexcellent indicator of problems with the use, design, and/or manufacture of aproduct. A single complaint that is thoroughly investigated may lead a companyto take remedial or corrective action. It may also take an ongoing analysis ofnumerous complaints before a trend is spotted that causes a company to initiatechanges in their product, labeling, packaging or distribution. The regulatoryexpectations for both pharmaceuticals and medical devices will be emphasized aswell as overview of best practices for timely and effective investigations.Trending is the only way a company can stay on top of emerging quality issuesand address those that are most pressing.
Medical Device Reporting (MDR) is the mechanism for FDA to receive significantmedical device adverse events from manufacturers, importers and userfacilities, so they can be detected and corrected quickly. User Facilities(e.g., hospitals, nursing homes) are required to report suspected medicaldevice related deaths to both the FDA and the manufacturers. User facilitiesreport medical device related serious injuries only to the manufacturer. If themedical device manufacturer is unknown, the serious injury is reported by thefacility to FDA. Health professionals within a user-facility should familiarizethemselves with their institution procedures for reporting adverse events tothe FDA.
The MDR process impacts device user facilities, manufacturers, importers, anddistributors. If you are a device user facility, you must report deaths andserious 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 seriousinjuries that your device has or may have caused or contributed to, you mustreport certain device malfunctions, and you must establish and maintain adverseevent files. If you are a manufacturer, you must also submit specifiedfollow-up.
Recall means the correction or removal of a device for human use where FDAfinds that there is a reasonable probability that the device would causeserious, adverse health consequences or death. It is an action taken to addressa problem with a medical device that violates FDA law. Recalls occur when amedical device is defective, when it could be a risk to health, or when it isboth defective and a risk to health.
A medical device recall does not always mean that you must stop using theproduct or return it to the company. A recall sometimes means that the medicaldevice needs to be checked, adjusted, or fixed. If an implanted device (forexample, a pacemaker or an artificial hip) is recalled, it does not always haveto be removed. When an implanted device has the potential to fail unexpectedly,companies often tell doctors to contact their patients to discuss the risk ofremoving the device compared to the risk of leaving it in place. FDA classifiesmedical device recalls into three categories, representing the potential riskto public health: Class I, II, and III.
Why you should attend:
· Understand thatalthough FDA does not specify a standard complaint handling system, therequirements do specify certain actions that shall be included in any system
· Grasp andcomprehend the definitions and elements of the regulatory requirements forComplaint Handling, Medical Device Reporting and handling of Recalls
· All personnelwho deal with customers, or who may receive a complaint call, must be trainedin the proper routing/handling of complaints
· Provideinformation about FDA's Medical Device Reporting (MDR) regulation and theVoluntary Reporting program called MedWatch
· Introduce youMedical Device Reporting and to help you better understand the process andbenefits of Voluntary Reporting and responsibilities
· LatestAmendments to the MDR Regulation to Implement FDAMA Changes
· To Recall orNot to Recall: Issues to consider regarding whether a Field Action is required
· Determine whena recall is required and how to manage a recall, who must report, when toreport, what to report, where to report, recordkeeping requirements, FDAregulatory authority, references and guidance
· Seminarattendees are encouraged to bring examples of their work from the functionalarea on the various topics as applicable for group discussion
· Review anddiscuss pain points, challenges and solutions
Areas Covered in the seminar:
· Reporting complaints
· Complaint evaluation and investigation
· Data collection and trending
· CAPA process for investigating complaints
· Accelerate complaints recording, investigation,reporting, escalation/triggers and closure cycle as cases are automaticallyrouted from one stage to the next
· Gain enterprise-wide visibility into the complaintsdata and track the process with performance metrics, dashboards or otherindicators
· Improve communication and teamwork on complaintsacross departments and functional areas
· Drive continuous improvement by tying correctiveactions with complaints for a closed loop quality process
· Improve management of the complaint lifecycle withreal-time trending and escalation of customer complaints
· Understand the History of MDR Regulation
· What types of Reports does the FDA receive and whomust 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 alternativeforms of adverse event reporting requirements?
· Basics of a Recall: Initiation, Classification andPublic Warning
· Medical Device Recall Reporting
· Recall Responsibilities & Requirements
· FDA's Role
· Introduction to Medical Device Recalls: IndustryResponsibilities
· Recall Communication and Strategy
· Monitoring and Auditing Recall Effectiveness
· Recall Termination
· Guidance for Industry, Trends and FDA Inspection &Enforcement Statistics and Trends
Day 1 – Agenda
Lecture 1: Complaint Handling:
Whatare the elements of an effective complaint management
Howdoes risk management influence complaint handling
Whatare the responsibilities of other departments?
Whatis the best way to train customer contact employees?
Lecture 2: MedicalDevice Reporting
Introductionto Medical Device Reporting
Whatare the key terms, definitions and forms?
MDRprocedures and processes
Whatare the requirements for developing, maintaining, and implementing written MDRprocedures that apply to me?
Howdo you manage international reporting requirements under your complainthandling system?
Lecture 3: Exercise and Recap of Day 1
Exercise on Product Complaints/Complaint Handling
Day 2 – Agenda
Lecture 4: MedicalDevice Reporting
eMDRElectronic Medical Device Reporting
Howto Report a Problem
EventProblem Codes and Manufacturer Evaluation Codes
MedWatch:Safety Information and AER Program
CompletingForm FDA 3500A
Lecture 5: Recalls
Whathappens in a medical device recall: Firm-initiated recall vs. mandatory recall
Whatinformation needs to be reported?
Whattypes of records do companies need to keep?
Priorto notifying FDA, what steps should you have taken?
Whatare the dos and don'ts when informing FDA of a product problem?
Whoshould be involved in the decision process?
Lecture 6: Exerciseand Recap of Day 2
Exercise - MDR and Recall
Who Will Benefit:
· RegulatoryAffairs Management
· RegulatoryAffairs Specialist
· QualityAssurance Management
· Marketing &Sales
· Legal Counsel
ABOUT SPEAKER –
David R. Dills
Regulatory Affairs & Compliance Consultant,
DavidR. Dills, Regulatory& Compliance Consultant with more than 24 years of hands-on experience anda proven track record within the FDA regulated industry, has an extensiveregulatory and compliance background with Class I/II/III and IVD devices,pharmaceutical operations, and manages activities within the global regulatoryand compliance space. He manages quality, regulatory and compliance projectswith multiple competing priorities having a direct impact on site operationsand commercial opportunities and develops strategies for governmental approvalto introduce new products to market, provides guidance on regulatory andcompliance requirements and prepares/reviews worldwidesubmissions/dossiers/technical files and addresses global regulatoryrequirements. Background encompasses broad capabilities in quality systems,validation, regulatory affairs, compliance, auditing, interfacing with theregulatory agencies, addressing enforcement actions and mitigating complianceexposure for companies via remediation, compliance engineering support,post-marketing surveillance and vigilance reporting; clinical affairs, establishand/or remediate Quality Management and documentation systems for GxPcompliance; preparation for ISO 13485 registration and CE Mark; andmulti-country product registrations and licensing; and working with NotifiedBodies, and AR's.
Location1: Phoenix AZ | 27th & 28th, February 2014| 9:00 AM- 6:00PM
Venue: Hilton Garden Inn Phoenix Midtown
Register now and save $200. (Early Bird)
Until January 15, Early Bird Price: $1,295.00
4000 N. Central Avenue, Phoenix, Arizona, 85012, USA
Location2: Baltimore MD|8th & 9th, May 2014| 9:00 AM- 6:00PM
Venue: Hilton Garden Inn Baltimore
Register now and save $200. (Early Bird)
Until February10, Early Bird Price: $1,295.00
625 S President St, 21202 Baltimore
Phone: 1800 447 9407
LIVE CHATSUPPORT - http://www.globalcompliancepanel.com/chat/client.php
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
Phone: 1800 447 9407
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