Medical Device Tracking is a very important aspect of the distribution chain of a medical device. This is because it is critical to have a mechanism by which a medical device can be traced and located in its place after it leaves the manufacturer. This system of tracking helps to identify a defective device and ensure that corrective measures are taken immediately.
Tracking is intended to facilitate notification and recall in the event a device presents a serious risk to health that requires prompt attention, promptly identify distribution information and remove a device from the market. The tracking provisions of section 519(e) of the Federal Food, Drug, and Cosmetic Act (FD & C Act), 21 USC 360i(e) were added in 1990 to the Safe Medical Devices Act (SMDA) and amended upon 1997 by The Food and Drug Administration Modernization Act (FDAMA). With this webinar you will understand:
The webinar will also provide examples of warning letters associated to 21 CFR 821 (Medical Device Tracking Requirements).Learning Objectives:
Sr Quality Regulatory Consultant, Quality and Regulatory Consulting Services
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, coaches on interpretation and application of US regulations, EU directives, specific country regulations (Japan, Canada, and others), national/international standards and guidance documents. She has also held positions within the CAPA, Material, Safety and Management Review Boards as well as represented Quality in Design Control phases.
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