ComplianceOnline

Expert Profile


Vanessa Lopez
Sr Quality Regulatory Consultant, Quality and Regulatory Consulting Services

Vanessa Lopez , Sr. 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 15 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.

Trainings by Expert

Complimentary webinar: FDA Inspections - Expecting the Expected
Category: Corporate Governance

Introduction to Root Cause Investigation for CAPA
Category: Medical Devices , Risk Management , All FDA Regulated Industry , FDA Audit and Inspection , Quality and Safety , Audits & Inspections , QMS, ISO 13485, CAPA , Supply Chain and Manufacturing , R & D , Risk Management & Controls , All FDA Regulated Functions , Audit & Inspection-Role , Quality Audit , All FDA Reg. based Audit , Medical Device Inspection , Documentation and Policy Management , Lifescience process & Procedures , Life sciences QA/QC , Research & Development , Device R & D , Regulations & Guidances , Best Practices & GXPs , Life Sciences , Regulatory Affairs , Documentation and Data Management , Common FDA Regulations , QA/QC

Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities
Category: Drugs and Chemicals (Pharma) , Medical Devices , All FDA Regulated Industry , GXP Pharmaceutical , GXP Medical Devices , Drug Marketing Compliance , Marketing and Promotion , Quality and Safety , QMS, ISO 13485, CAPA , Supply Chain and Manufacturing , R & D , Drug Development , Drugs Regulations , Life sciences QA/QC , Research & Development , Drug R & D , Device R & D , Regulations & Guidances , Life Sciences , Regulatory Affairs , Common FDA Regulations , QA/QC

Supplier and Service Provider Controls: FDA Expectations
Category: Medical Devices , All FDA Regulated Industry , GXP Medical Devices , Quality and Safety , Supply Chain and Manufacturing , Risk Management & Controls , All FDA Regulated Functions , Audit & Inspection-Role , All FDA Reg. based Audit , Medical Device Inspection , Documentation and Policy Management , Lifescience process & Procedures , Life sciences QA/QC , Supply chain & Procurement , Regulations & Guidances , Life Sciences , Regulatory Affairs , Common FDA Regulations , QA/QC

Are You and Your Suppliers Prepared for Notified Bodies Unannounced Audits?
Category: Medical Devices , GXP Medical Devices , Audits & Inspections , Supply Chain and Manufacturing , Audit & Inspection-Role , Medical Device Inspection , Life sciences QA/QC , Regulations & Guidances , Regulatory Affairs , Documentation and Data Management , QA/QC

Medical Device Tracking Requirements
Category: Medical Devices , All FDA Regulated Industry , GXP Medical Devices , Marketing and Promotion , Quality and Safety , QMS, ISO 13485, CAPA , Supply Chain and Manufacturing , Life sciences QA/QC , Supply chain & Procurement , Regulations & Guidances , Life Sciences , Regulatory Affairs , QA/QC

FDA Inspections: Understanding the Core Elements – Part I
Category: All FDA Regulated Industry

FDA: Mock and Pre-Approval Inspections (PAIs) - Part II
Category: All FDA Regulated Industry

Drug Manufacturing Inspection Part III
Category: All FDA Regulated Industry