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Follow on Google News | Effective Complaint Handling, Medical Device Reporting and Recalls 20132-day In-person Seminar on “Effective Complaint Handling, Medical Device Reporting and Recalls” in Boston
Complaint handling lies at the heart of a good quality system. A complaint about a product is not only an indicator of how a manufacturer’ Complaints should be thoroughly analyzed and investigated. Manufacturers of medical devices should try to understand the problem at its root and try to come up with solutions to fix them. Complaint handling is a specialized part of a quality system, and requires a professional, systematic and process oriented approach. At this seminar, the speaker, David Dills will explain the ways by which a medical device manufacturer can devise a strategy of dealing with complaints. Analysis of a single complaint may not lead to answers, but doing it over a series of complaints will help manufacturers zero in on a trend or pattern. This is an important step, because it helps the manufacturer come up with ways of dealing with how to fix the problem. The speaker will also elaborate on Medical Device Reporting (MDR). MDR is FDA’s mechanism for receiving significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. The speaker will spell out the nuances of this system during this seminar. He will also impart expertise on recalls, another crucial component of the complaint handling system. There are different rules for recall for different classes of medical devices. Manufacturers need to know these in detail. David Dills will throw light on these aspects. Overall, this is going to be a seminar in which the participants can get familiar with the most important aspects of complaint handling, a quintessential part of a quality system. ------------------------------------------------------------ About the Speaker: David Dills, an independent Regulatory & Compliance Consultant, worked for PAREXEL Consulting till July 2008, when he had to leave due to a service line organizational shakeup. Prior to joining the consultancy, Mr. Dills provided independent consultative services in various capacities from pre-marketing to post-marketing within the technical, quality, regulatory affairs and compliance arena to pharmaceutical, Class I/II/III medical devices, in-vitro diagnostics and biologics/biotech companies with an emphasis on establishing sustainable compliance systems. ------------------------------------------------------------ The seminar will have the following agenda: Day 1 –Agenda Lecture 1: Complaint Handling Lecture 2: Medical Device Reporting Lecture 3: Exercise and Recap of Day 1 Day 2 –Agenda Lecture 4: Medical Device Reporting Lecture 5: Recalls Lecture 6: Exercise and Recap of Day 2 o Exercise - MDR and Recall o Quiz ------------------------------------------------------------ For whom: This seminar will benefit professionals in: a. Regulatory Affairs Management b. Regulatory Affairs Specialist c. Auditors d. Compliance Officer e. Compliance Specialist f. Clinical Affairs g. Quality Assurance Management h. Marketing & Sales i. Distributors/ j. Legal Counsel k. Engineering/ l. Operations/Manufacturing m. Consultants ------------------------------------------------------------ Venue, date and timings: The venue for this seminar is the Courtyard Boston Logan Airport, 225 William F. McClellan Highway Boston, Massachusetts 02128. The seminar will be on July 25 and 26, from 9 A.M to 6 P.M PDT. ------------------------------------------------------------ $1,495.00 per participant. Discounts are available for group participation in the following manner:Call our representative on 1800 447 9407 to have your seats confirmed. ------------------------------------------------------------ Contact Information: Event Coordinator Toll free: 1800 447 9407 Fax: 302 288 6884 Email: support@globalcompliancepanel.com GlobalCompliancePanel NetZealous LLC, 161| Mission Falls Lane| Suite 216, Fremont| CA 94539 End
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