The FDA Inspection: From SOP to 483
Duration : 60 Minutes
Jeff Kasoff,
Jeff Kasoff, RAC, CMQ/OE, Lean Black Belt, has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff unique Read more
The FDA inspection is a make-or-break experience. You’ve got to have a Quality Management System that is in substantial compliance, and you’ve got to be able to communicate this to the investigator. This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.
Course Objectives:
• Understanding the types of inspections
• Best practices for inspection preparation
• Dedicated personnel for inspection
• Facility resources to support the inspection
• Internal audits
• Importance of an SOP for inspections
• Behavior during the inspection: What to say and do, and what NOT to say and do
• Overview of the inspection itself
• How and when to craft a written response
Course Outline:
• Types of FDA inspection
• What to expect during an FDA inspection
• What records to share with the FDA investigator
• How to document the FDA inspection
• How to respond to the FDA inspection
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies, since FDA inspects across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
• Quality Auditors
• Compliance Officers
• Executive Management
• Managers/Directors/Supervisors and Personnel related to:
• Regulatory Compliance and Regulatory Affairs;
• Quality Management System;
• Quality Assurance;
• Product Development;
• Engineering;
• Manufacturing;
• Complaint Handling
• Personnel new to the regulated industry
• Training personnel
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
Refund / Cancellation policyGet In Touch
Similar Trainings
Understanding Combination Products: Navigating the Rules and Regulations
LIVE : Scheduled on
30-April-2024 :01:00 PM EDT
|
European Union Device Regulation (EU MDR)
LIVE : Scheduled on
01-May-2024 :01:00 PM EDT
|
Risk Based Design Control
LIVE : Scheduled on
15-May-2024 :01:00 PM EDT
|