Zurich, Switzerland: +41 - 43 434 80 33   |   US: (510) 962-8903   |   support@traininng.com

Overview

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.

Why should you Attend

This course is designed to provide participants with an understanding of the purpose of FDA Inspections, the consequences of not complying with their requirements and how to prepare and manage these types of inspections. It will provide details on each topic from the course outline.

Areas Covered in the Session

  • Purpose of FDA Inspections
  • How Does FDA Decide Who to Inspect
  • Inspection Frequency, Relationship to PMAs/NDAs/BLAs and Reference to the Inspection Model
  • FDA Enforcements
  • Example of DOJ Pharma/Device Settlements
  • QSIT (Devices) Overview
  • How Does "QSIT" Relate to the Pharmaceutical Industry
  • Preparation for an FDA Inspection
  • Inspection Process: What to Expect From FDA's Arrival Up to Their Exit
  • Timelines to Respond to 483s, Warning Letters and Sequence of Response
  • Inspection Findings-Trends
  • Examples of Inspectional Findings on Warning Letters
  • Challenges
  • Conclusions

Who Will Benefit

  • Quality Auditors
  • Compliance Officers
  • Executive Management
  • Managers/Directors/Supervisors and Personnel related to:
    • Regulatory Compliance and Regulatory Affairs
    • Quality Management System
    • Quality Assurance
    • Quality Control
    • Product Development
    • Engineering
    • Manufacturing
    • Risk Management
    • Complaint Handling
  • Personnel New to the Regulated Industry
  • Training Personnel
  • Document Control Personnel

Speaker Profile

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.