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Europe’s Compliance Plan for Medical Devices: Preparing for and Managing EU Notified Bodies Audits
This presentation is designed to provide medical device professionals with the information they need to prepare for and manage routine surveillance and unannounced notified body audits. You will learn the rationale, strategies and flow on how to plan for the audit, the audit process and approach, and which company roles should be assigned for notified body audits. This presentation will also show you the major changes in medical device CE certification as it relates to unannounced audits and other matters, as a result of EU Commission Recommendation 2013/473/EU. The impact this recommendation has on manufacturers, notified bodies, subcontractors, and suppliers will be explored. In addition, this presentation provides background information on notified bodies’ purpose and CE marking.
Specifically you will learn:
This course will be of benefit:
Vanessa Lopez is a Senior Principal Quality, Regulatory, and Compliance Consultant. Ms. Lopez has held a wide variety of leadership roles in the Medical Device (Class: I, II, and III), Pharmaceutical (API; Finished Product) and Environmental regulated industries as well as the Consulting Services industry. She has worked for Edwards LifeSciences, Roche Diagnostics, Eli Lilly, Pall LifeSciences, among others. She possesses over 25 years of experience focused on development, implementation, driving improvements and monitoring of quality assurance, quality control, regulatory compliance, regulatory affairs, quality systems and supplier quality activities. Ms. Lopez has in-depth knowledge and coaches on interpretation and application of US regulations, EU directives, specific country regulations (Japan, Canada, and others), national/international standards and guidance documents.
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