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2 DAY SEMINAR Effective Compliance Strategies for Complaint Handling, Medical Device Reporting and Recalls

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Website https://worldcomplianceseminars.com/seminardetails/39 | Edit Freely

Category

Deadline: July 09, 2018 | Date: July 11, 2018-July 12, 2018

Venue/Country: Boston,MA, U.S.A

Updated: 2018-05-04 13:54:20 (GMT+9)

Call For Papers - CFP

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.

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.

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

Speaker Profile

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.

Price: Seminar One Registration $ 1295| Special Group Discount Register for Four attendees $ 3995

Address: Hilton Garden Inn Boston Logan Airport

100 Boardman Street, Boston, Massachusetts 02128 -USA


Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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