Speaker Profile

Vanessa
Vanessa Lopez
Sr. Quality and Regulatory Consultant, Quality and Regulatory Consulting Services (Consulting)

Vanessa Lopez - Sr. Principle Quality, Regulatory and Compliance Consultant. She 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 and Company, 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/EU MDR and IVDR, 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.

Upcoming Webinars Recorded Webinars
Vanessa Lopez

Best Practices to Prepare for and Manage FDA Inspections

Preparing for and managing an FDA Inspection; the actual flow of company activities and roles; the inspection process, and the impact of non-compliance to FDA requirements on the medical devices/pharmaceutical firms, competiveness in the market, revenue, distribution, reliability status, and partnerships with suppliers, among others. It will also provides the challenges from the results of an inspection, in preparing and managing an inspection, and the benefits of successful results from an FDA inspection.

Speaker: Vanessa Lopez | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Vanessa Lopez

Best Practices to Prepare for and Manage FDA Inspections

Preparing for and managing an FDA Inspection; the actual flow of company activities and roles; the inspection process, and the impact of non-compliance to FDA requirements on the medical devices/pharmaceutical firms, competiveness in the market, revenue, distribution, reliability status, and partnerships with suppliers, among others. It will also provides the challenges from the results of an inspection, in preparing and managing an inspection, and the benefits of successful results from an FDA inspection.

Speaker: Vanessa Lopez | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Vanessa Lopez

2-Hour Virtual Seminar on 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.

Speaker: Vanessa Lopez | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Vanessa Lopez

Best Practices to Prepare for and Manage FDA Inspections

Preparing for and managing an FDA Inspection; the actual flow of company activities and roles; the inspection process, and the impact of non-compliance to FDA requirements on the medical devices/pharmaceutical firms, competiveness in the market, revenue, distribution, reliability status, and partnerships with suppliers, among others. It will also provides the challenges from the results of an inspection, in preparing and managing an inspection, and the benefits of successful results from an FDA inspection.

Speaker: Vanessa Lopez | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Vanessa Lopez

Best Practices to Prepare for and Manage FDA Inspections

Preparing for and managing an FDA Inspection; the actual flow of company activities and roles; the inspection process, and the impact of non-compliance to FDA requirements on the medical devices/pharmaceutical firms, competiveness in the market, revenue, distribution, reliability status, and partnerships with suppliers, among others. It will also provides the challenges from the results of an inspection, in preparing and managing an inspection, and the benefits of successful results from an FDA inspection.

Speaker: Vanessa Lopez | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Vanessa Lopez

2-Hour Virtual Seminar on 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.

Speaker: Vanessa Lopez | View Anytime | Duration: 2 Hours | Price: $440.00 | View Details