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2-hr Virtual Seminar: FDA Inspections - Understanding the Core Elements

Duration : 2 Hours

This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they require to prepare for and manage FDA inspections. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.

Course Objectives:

The course is designed to meet the objectives of: 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 products, competitiveness 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.

Course Outline:

• 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

What You Get:

•  Training Materials
•  Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Quality Auditors
• Compliance Officers
• Executive Management
• Managers/Directors/Supervisors and Personnel related to:
     o Regulatory Compliance and Regulatory Affairs;
     o Quality Management System;
     o Quality Assurance;
     o Quality Control;
     o Product Development;
     o Engineering;
     o Manufacturing;
     o Risk Management;
• Complaint Handling
• Personnel new to the regulated industry
• Training personnel
• Document Control Personnel

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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