This Medical device training will provide valuable assistance and guidance to all medical device companies and user facilities involved in medical device vigilance.

Description
A revised medical device guidance document on post marketing vigilance (MEDDEV 2.12-1 rev 5) was published in April 2007 by the European Commission and came into force on January 1, 2008. The 2007 update provides more guidance than the previous version, introduced in 2001, and includes new reporting terminology and concepts such as periodic summary reporting and trend reporting. In addition, the terms advisory notice, near incident, and recall have been eliminated or replaced.

The vigilance guidelines are part of a set of European medical device guidelines, known as MEDDEV documents, which are intended to promote a common approach by all involved parties on interpreting and complying with the Medical Device Directive. MEDDEV includes new reporting terminology and concepts such as “periodic summary reporting” and “trend reporting.” In addition, the timescale for reporting incidents is stricter. The terms “advisory notice,” “near incident” and “recall” have been eliminated or replaced by the new terms. As with the 2001 version, the new version refers to the incorporation of the views of the Global Harmonization Task Force (GHTF) into the European context.

This indicates a continuing support of the regulatory harmonization initiatives of the GHTF. Although the MEDDEVs are not legally binding, it is likely that all Competent Authorities will follow the procedures outlined in the new guidelines and expect manufacturers, their authorized representatives and others involved in the management and reporting of adverse incidents to follow them as well. Although a transition period was allowed until the end of 2007, the revised guidelines will undoubtedly result in the need for manufacturers, authorized representatives, and distributors to quickly make substantial changes to their standard operating procedures (SOPs) and other documents.

Manufacturers marketing medical devices in Europe, as well as their distributors and authorized representatives, urgently need to review the revised guidance document in detail. It is essential that manufacturers make the necessary changes to their quality management system and are ready to implement the new postmarket vigilance reporting guidelines that were implemented in January 2008.

Areas Covered in the seminar:

• Learn about the latest changes to MEDDEV and Medical Device Vigilance and impact on medical device manufacturers.
• Understand the "new" terminology and concepts.
• How to report incidents as recommended by the guidance.
• Understand the expectations for reporting and timelines.
• Understand which amendments impact the European vigilance system.
• Understand the guidelines that cover incidents involving devices that carry the CE mark and devices that do not.
• Understand why the guidelines contain some controversial aspects, including the extension of their scope and the new approach of immediate reporting unless delays can be justified.
• Learn why GHTF is an integral component of the new post marketing vigilance guidelines and the expectations for reporting and timelines.

Who Will Benefit:

This webinar will provide valuable assistance and guidance to all medical device companies and user facilities involved in medical device vigilance. The employees who will benefit include:

• All levels of Management for all departments and those who desire a better understanding or a "refresh" overview.
• QA/QC
• Marketing & Sales/Customer Service
• Engineering/Technical Services/Operations
• Consultants/Distributors
• Regulatory Affairs and Compliance

Instructor Profile:
David R. Dills, Industry Consultant, departed PAREXEL Consulting in July 2008 due to service line organizational change within SCOPE (Strategic Compliance & Operational Excellence). Prior to joining the consultancy Mr. Dills has 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. Mr. Dills also served as Director of Publications, Regulatory & Compliance for the Institute of Validation Technology. Through his work, Mr. Dills has been affiliated within the life sciences industry for more than nineteen years with increasing responsibilities in QA, Quality Engineering, Validation, RA/Compliance, and Corporate/Operations Management and previously employed on behalf of globally recognized device manufacturers and service providers in conjunction with marketing and business development responsibilities.

Key areas of focus include product development and commercialization strategies, regulatory classifications, applications and submissions, regulatory and clinical consulting, rapid regulatory crisis response, involved in consent decree/CIA activities, improve and remediate quality management systems and documentation, inspection readiness preparedness for manufacturers and serves in an Expert Witness capacity for a third party. Mr. Dills has prepared and executed effective paths to obtaining approvals, worked effectively across functions for overall corporate compliance, and aligned GxP compliance in a fashion that supports a company’s business strategies and goals.

Mr. Dills areas of interest and expertise include executing process validation, supplier qualification, training, internal/due diligence audits, policy/procedure development, PM, risk management/assessment, ISO 9001/13485/14971, MDD 93/42/EEC, CE Marking, remediation, GxPs, SW Validation/IT Network, MDR/AE/product complaints, design/change control, CAPA, PMA, IDE, 510(k), NDA and e-CTD/CMCs submissions, interfacing with international regulatory bodies, QSIT and PAI Inspections, sample accountability, and other related functions and tasks.

Mr. Dills currently serves on the Faculty Advisory Board for the Pharmaceutical Training Institute and Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology. He serves on the Readers’ Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore’s Who’s Who of Professionals. Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter.