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2014 - Hosting Regulatory Inspections
Topics/Call fo Papers
DESCRIPTION
Being inspected by a regulatory agency, whether the FDA, foreign regulatory agencies (e.g. European, Japanese) or any agency regulating parts of the pharma, biotech or medical device industries, e.g. for CLIA certification, is a normal part of doing business. Yet many companies are unprepared for such an inspection resulting in citations or other adverse action by the agencies.
Why should you attend/Description of the topic:
The course will go through what typically goes on during an FDA inspection and 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.
Areas Covered in the Session:
Types of inspections
What goes on during the FDA inspection
What goes on during an international inspection
What goes on during a CLIA inspection
Who is involved
The SOP for Inspections
What if you are asked to talk to the inspector
What do you allow the inspector to have access to
How to follow up after the inspection
How to respond to any adverse inspection findings
How to eliminate adverse inspection findings
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
Webinar Includes:
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
90 Minutes Live Presentation
Certificate of Attendance
Being inspected by a regulatory agency, whether the FDA, foreign regulatory agencies (e.g. European, Japanese) or any agency regulating parts of the pharma, biotech or medical device industries, e.g. for CLIA certification, is a normal part of doing business. Yet many companies are unprepared for such an inspection resulting in citations or other adverse action by the agencies.
Why should you attend/Description of the topic:
The course will go through what typically goes on during an FDA inspection and 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.
Areas Covered in the Session:
Types of inspections
What goes on during the FDA inspection
What goes on during an international inspection
What goes on during a CLIA inspection
Who is involved
The SOP for Inspections
What if you are asked to talk to the inspector
What do you allow the inspector to have access to
How to follow up after the inspection
How to respond to any adverse inspection findings
How to eliminate adverse inspection findings
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
Webinar Includes:
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
90 Minutes Live Presentation
Certificate of Attendance
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Last modified: 2014-10-17 14:36:35