Upcoming Events at WILL BE ANNOUNCED SOON
Thu Sep 20, 9:00 AM - Fri Sep 21, 6:00 PM
WILL BE ANNOUNCED SOON
San Diego, CA, San Diego, CA 92101
Community: Times Square
Description
The course will go through what typically goes on during an FDA inspection and will then cover how to prepare for, host and follow up to a regulatory inspection.
Event Details
Course "Hosting FDA Regulatory Inspections" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Description:
Why you should attend:
The course will go through what typically goes on during an FDA inspection and will then cover how to prepare for, host and follow up to a regulatory inspection. It will focus the things that you should do or not do during the inspection. Typically FDA inspections can be highly structured and there are usually procedures that are to be followed. It is important for anyone who might be involved in the inspection to be aware of these procedures.
The course will also provide information for inspections conducted by international agencies as well as non- FDA agencies, including self inspections for manufacturing. It will explain how to prepare for an inspection, how to handle a scheduled or non-scheduled inspection, what to expect during an inspection and what follow up to expect after an inspection.
Finally, the course will provide information on how to respond to issues that come up during inspections and what to do to ensure best outcome from the inspection.
________________________________________
Who will benefit:
Anyone who would be involved in the trial
• Regulatory Affairs professionals
• Quality Assurance
• Physicians
• Nurses
• Lab Technicians
• Operations
• Clinical Data Management
• Laboratory Management
• Manufacturing
• IT
Agenda:
Day 1 Schedule
________________________________________
Lecture 1: FDA Inspections: FDA Inspection Program Overview
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Lecture 2: FDA Inspections: Key factors for a successful FDA inspection
________________________________________
Lecture 3: FDA Inspections: Quality System Readiness
________________________________________
Lecture 4: FDA Inspections: Information Readiness
________________________________________
Lecture 5: FDA Inspections: Organization Readiness
________________________________________
Lecture 6: FDA Inspections: Manage Inspection Outcomes
Day 2 Schedule
________________________________________
Lecture 1: FDA Inspections: Managing Regulatory Risk
_____________________________
Description:
Why you should attend:
The course will go through what typically goes on during an FDA inspection and will then cover how to prepare for, host and follow up to a regulatory inspection. It will focus the things that you should do or not do during the inspection. Typically FDA inspections can be highly structured and there are usually procedures that are to be followed. It is important for anyone who might be involved in the inspection to be aware of these procedures.
The course will also provide information for inspections conducted by international agencies as well as non- FDA agencies, including self inspections for manufacturing. It will explain how to prepare for an inspection, how to handle a scheduled or non-scheduled inspection, what to expect during an inspection and what follow up to expect after an inspection.
Finally, the course will provide information on how to respond to issues that come up during inspections and what to do to ensure best outcome from the inspection.
________________________________________
Who will benefit:
Anyone who would be involved in the trial
• Regulatory Affairs professionals
• Quality Assurance
• Physicians
• Nurses
• Lab Technicians
• Operations
• Clinical Data Management
• Laboratory Management
• Manufacturing
• IT
Agenda:
Day 1 Schedule
________________________________________
Lecture 1: FDA Inspections: FDA Inspection Program Overview
________________________________________
Lecture 2: FDA Inspections: Key factors for a successful FDA inspection
________________________________________
Lecture 3: FDA Inspections: Quality System Readiness
________________________________________
Lecture 4: FDA Inspections: Information Readiness
________________________________________
Lecture 5: FDA Inspections: Organization Readiness
________________________________________
Lecture 6: FDA Inspections: Manage Inspection Outcomes
Day 2 Schedule
________________________________________
Lecture 1: FDA Inspections: Managing Regulatory Risk
_____________________________
