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 system
- Grasp and comprehend the definitions and elements of the regulatory requirements for Complaint Handling, Medical Device Reporting and handling of Recalls
- All personnel who deal with customers, or who may receive a complaint call, must be trained in the proper routing/handling of complaints
- Provide information about FDA's Medical Device Reporting (MDR) regulation and the Voluntary Reporting program called MedWatch
- Introduce you Medical Device Reporting and to help you better understand the process and benefits of Voluntary Reporting and responsibilities
- Latest Amendments to the MDR Regulation to Implement FDAMA Changes
- To Recall or Not to Recall: Issues to consider regarding whether a Field Action is required
- Determine 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 guidance
- Seminar attendees are encouraged to bring examples of their work from the functional area on the various topics as applicable for group discussion
- Review and discuss pain points, challenges and solutions
Areas Covered in the Session:
- 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 automatically routed from one stage to the next
- Gain enterprise-wide visibility into the complaints data and track the process with performance metrics, dashboards or other indicators
- Improve communication and teamwork on complaints across departments and functional areas
- Drive continuous improvement by tying corrective actions with complaints for a closed loop quality process
- Improve management of the complaint lifecycle with real-time trending and escalation of customer complaints
- Understand the History of MDR Regulation
- What 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 Warning
- Medical Device Recall Reporting
- Recall Responsibilities & Requirements
- FDA's Role
- Introduction to Medical Device Recalls: Industry Responsibilities
- Recall Communication and Strategy
- Monitoring and Auditing Recall Effectiveness
- Recall Termination
- Guidance for Industry, Trends and FDA Inspection & Enforcement Statistics and Trends
Who will benefit:
- Regulatory Affairs Management
- Regulatory Affairs Specialist
- Compliance Officer
- Compliance Specialist
- Clinical Affairs
- Quality Assurance Management
- Marketing & Sales
- Distributors/Authorized Representatives
- Legal Counsel
- Engineering/Technical Services
Day 1 Schedule
- What are the elements of an effective complaint management
- How does risk management influence complaint handling
- 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 investigation
- What 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 responsibility
- Manufacturer should develop a method for maintaining records of complaints and investigations that: is functional and economical, meets company needs, and meets FDA requirements and expectations
- Identify designated complaint handling unit
- Instructions for documenting complaint information
- Process for evaluating complaints
- Process for investigating complaints
- Identify and process MDR's
- How to process customer returns
- Records and trend analysis
- Complaint closure
- Examples of tools currently being used to conduct investigations
- How far and in-depth do you go with your investigations
- What are current FDA "hot" buttons and trends, benchmarks and best practices for investigations
- How to become a "good" investigator and the emphasis on closed-loop investigations
- Written Procedures: Designated Complaint Handling Unit, Training and Records
- Recent Enforcement Actions
Medical Device Reporting
- Introduction to Medical Device Reporting
- What are the key terms, definitions and forms?
- MDR procedures and processes
- What 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 Assessments
Exercise and Recap of Day 1
- Exercise on Product Complaints/Complaint Handling
Day 2 Schedule
Medical Device Reporting
- eMDR Electronic Medical Device Reporting
- How to Report a Problem
- Event Problem Codes and Manufacturer Evaluation Codes
- MedWatch: Safety Information and AER Program
- Completing Form FDA 3500A
- What 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 Reports
- User Facility Reporting, Importer Reporting and Manufacturer Reporting Requirements
- What happens in a medical device recall: Firm-initiated recall vs. mandatory recall
- What 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 FDA
- How 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 operational
- Understand what is required for the recall strategy as expected by FDA
- Depth of recall and using a viable, sustainable and effective strategy
- Understand why the documentation and paper trail are so critical and termination of a recall
- Discuss most recent recalls not only for devices but pharmaceuticals and why the numbers are alarming
Exercise and Recap of Day 2
- Exercise - MDR and Recall
David R. Dills
Regulatory 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: Boston, MA Date: January 19th & 20th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: Embassy Suites Boston Logan Airport
207 Porter Street Boston, MA 02128
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