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Summary: GlobalCompliancePanel will organize a RAPS-approved two-day, in-person seminar in Phoenix, AZ on the topic, “Effective Complaint Handling, Medical Device Reporting and Recalls” on February 27 and 28, 2014 (Thursday & Friday). David Dills, a well-known independent Regulatory & Compliance Consultant, will be the speaker at this two-day session. Course "Effective Complaint Handling, Medical Device Reporting and Recalls" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Venue, date and timings: The venue for this seminar, which will be on February 27 and 28, 2014 from 9 A.M to 5 P.M, will be announced soon. What the seminar is about: 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’s product is perceived in the market; effective complaint handling system is an FDA requirement, too. 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 R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements. Background encompasses broad capabilities in quality systems, validation, regulatory affairs, compliance, auditing, interfacing with the regulatory agencies, addressing enforcement actions and mitigating compliance exposure for companies via remediation and much more. The agenda: 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/Authorized Representatives j. Legal Counsel k. Engineering/Technical Services l. Operations/Manufacturing m. Consultants About GlobalCompliancePanel: GlobalCompliancePanel (GCP) is a specialized offering from NetZealous LLC, a Technology and Business Process Solutions and Services Company registered in Fremont, CA. It is a fountainhead for Continuous Professional Education, compliance training and consulting. GCP offers a broad range of high quality regulatory and compliance-related services relating to Medical Devices, Pharmaceutical, FDA, Food, PCI industries, and SOX. Some of the Governing Areas its webinars cover are GxP (Manufacturing/Clinical/Lab), EU and ISO. These seminars are an extension of online trainings, at which GCP has conducted around 700 webinars since inception on a variety of topics for these industries /verticals. More than 30,000 professionals have benefited from these trainings. GlobalCompliancePanel’s trainings are focused, flexible and tailored to the client’s need. This is the next in a series of regulatory and compliance related seminars that GlobalCompliancePanel has been organizing all over the US. Its previous seminars have met with resounding success. GlobalCompliancePanel’s seminars have helped participants reach their career milestones. In bringing globally renowned experts in the field of regulatory compliance and executives in the industry together, GlobalCompliancePanel fosters a learning experience. With trainings that are focused and relevant, GlobalCompliancePanel seeks to serve as a bridge in the area of continuous professional education for regulatory and compliance-related fields. Price: Register now and save $200. (Early Bird) Until January 15: Early Bird Price: $1,295.00 From January 16 to February 25: Regular Price: $1,495.00 Discounts are available for group participation in the following manner: For two attendees: 10% discount For three to six attendees: 20% discount For seven to 10 attendees: 25% discount For more than 10 attendees: 30% discount To avail the above group discounts, all the participants should register by making a single payment. Please note that the registration will be closed two days (48 hours) prior to the start date of the seminar. 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 Website: https://www.globalcompliancepanel.com LIVE CHAT SUPPORT- http://www.globalcompliancepanel.com/chat/client.php GlobalCompliancePanel NetZealous LLC, 161 Mission Falls Lane Suite 216, Fremont CA 94539
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