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Vanessa Lopez

Ms. Lopez has held a wide variety of leadership roles in the Medical Device (Class: 1, 2, and 3), Pharmaceutical (API; Finished Product) and Environmental regulated industries as well as in 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. 

 Webinar Id: LSHCVL001
 View Anytime
 Duration 90 mins

Supplier and Service Provider Controls: FDA Expectations

This webinar will provide the regulatory requirements (US) of 21 CFR Section 820.50 (Purchasing Control) for the Medical Device industry and provide you with examples. It will furnish details on what should your Purchasing/Supplier Control management system address. Supply chain activities (including, the increase in outsourcing materials, components , manufacturing and services) have become more complex to manufacturers and oversight h........

$167 Recorded (6 months unlimited access)

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