David
July 11 - 12, 2018 - Hollywood FL USWorld Compliance Seminars
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Phone:347 282-5400
2 DAY SEMINAR Effective Compliance Strategies for Complaint Handling, Medical Device Reporting and Recalls Location 1: Boston,MA Jul 11 - 12 Description Complaint handling systems have come under intense scrutiny by the FDA in recent years and enforcement trends confirm this as of recent. The seminar will examine the current industry and FDA environment and provide you with the knowledge and tools for survival as well as making existing complaint handling systems more robust, easier to manage and enforce. It will provide a step-by-step guide for establishing, deploying, managing and auditing your Complaint Handling System for today's medical device industry environment. 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 on-going 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. 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. Manufacturers, User Facilities, and Importers are required to submit certain adverse events to FDA. Health professionals and consumers may submit reports of device adverse events or product problems to FDA via the MedWatch program in one of several ways. This seminar will provide the snapshot of the of the MDR regulation, why you have to report, how and where to report, introduce you to the forms and provide step-by-step instructions as to your responsibilities. Medical device recalls are usually conducted voluntarily by the manufacturer. In rare instances, where the manufacturer or importer fails to voluntarily recall a device that is a risk to health, FDA may issue a recall order to the manufacturer and the seminar will describe the procedures the FDA will follow in exercising its medical device recall authority, as well as introduce the audience to the recall classification process, recall strategy, recall status reports, termination of a recall, effectiveness checks, company’s recall procedure, among other key areas. Why should you attend (Course Objective)? • 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 Course Description: 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. Areas Covered • Reporting complaints • Complaint evaluation and investigation and effective root cause analysis • 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 to submit e-MDR reports and ensure timely reporting requirements are met for MedWatch 3500A • 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 and Classification Levels • 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 Trend Who will Benefit This seminar will provide an overview and in-depth snapshot of the process for managing your product complaint/complaint handling program, Medical Device Reporting program and addressing and facilitating Recalls. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the complaint handling, MDR and recall process from start to finish, including: • Regulatory Affairs Management • Regulatory Affairs Specialist • Auditors • Compliance Officer • Compliance Specialist • Clinical Affairs • Quality Assurance Management • Marketing & Sales • Distributors/Authorized Representatives • Legal Counsel • Engineering/Technical Services • Operations/Manufacturing • Consultants Seminar One Registration $ 1295| Special Group Discount Register for Four attendees$ 3995| David R. Dills, Global Regulatory Affairs & Compliance Consultant, Interim President, currently provides global regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III medical device, including combination products, In Vitro Diagnostics, nutraceuticals, and biotech/biopharmaceuticalmanufacturers in multiple medical specialties and therapeutic areas, including orphan drugs on the global landscape, and has an accomplished record with more than 28 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA’s, warning letters, 483 observations, and customer generated compliance events, and prepares for and conducts QS, supplier, and regulatory audits. He provides oversight of GCP operations and clinical trials and prepares companies for regulatory inspections at all phases. He has been directly involved with constructing, reviewing, and/ or remediating regulatory submissions and applications, including 510(k), PMA, IDE, HUD, pre-IND/IND, BLA, CMC,/e-CTD, e-TMF, ANDA and NDA submissions, preparing responses to AI’s and deficiency letters, Supplements, Amendments, acting U.S. Agent, works closely with the key stakeholders and Agency/Center Reviewers regarding Pre-Sub meetings and negotiations; clinical affairs and study submissions; and provides regulatory submissions and postmarket project leadership and guidance covering different therapeutic and medical specialties based on classification. He has hands-on experience with all phases of medical device premarketing and postmarketing commercialization and for drug development and biopharma manufacturing operations. https://worldcomplianceseminars.com/seminardetails/39