Online Safety Community

FDA inspection is not going to invite an FDA action such as a 483 or a Warning Letter

If there is one common cause for apprehension between the smallest and biggest, and the best known and least known organizations; it has to be an FDA inspection! Any organization that is subject to an FDA inspection has to get absolutely everything of everything about its activities right to a T, to such an extent that it should be sure simply all the time, through all its processes, that an FDA inspection is not going to invite an FDA action such as a 483 or a Warning Letter. This means compliance at its highest and lowest levels.

1749_RMB_MicrobiologyMarketing_banne2

To simplify matters to an extent, the FDA has tried to be of some assistance to help in monitoring the conduct of all aspects of the conduct and reporting of organizations involved in FDA-regulated research. This has concretized in the form of the FDA’s Bioresearch Monitoring Program, or BIMO. This on-site inspection and data audit program can be used as a reference guide by industries in FDA-regulated research industries. Adherence to it is a yardstick for compliance with FDA regulations in the field.

In other words,compliance to the implementation requirements of the BIMO is a fair indicator of how well the organization comes out unscathed out of an FDA inspection. Meant for monitoring Clinical Investigators (CIs), the Institutional Review Boards (IRBs), Sponsors or Contract Research Organizations (CROs)/Monitors, and nonclinical laboratories; the BIMO spans quite a range of players in the FDA-regulated research.

What are the BIMO’s objectives?

The FDA’s Bioresearch Monitoring Program has two important objectives:

  • Protecting the welfare, rights and safety of human research subjects
  • Ensuring that the data collected by researchers is reliable and is of acceptable integrity and quality

The-Pros-and-Cons-of-Biologics-for-UC-1440x810https://compliance4all14.files.wordpress.com/2018/03/the-pros-and-cons-of-biologics-for-uc-1440x810.jpg?w=150&h=84 150w, https://compliance4all14.files.wordpress.com/2018/03/the-pros-and-c... 300w, https://compliance4all14.files.wordpress.com/2018/03/the-pros-and-c... 722w" sizes="(max-width: 490px) 100vw, 490px" width="490" height="275" />

What are the BIMO’s functions?

The FDA’s Bioresearch Monitoring Program has a few functions, which research organizations that have to survive an FDA inspection could do well to comprehend. These include:

  • Clinical data auditing
  • Inspection of the ongoing clinical research
  • Subjecting nonclinical laboratories and IRBs to inspections
  • Taking steps to train, educate and implement the FDA’s Application Integrity Policy.

Understand the underlying causes that lead to an inspection

The key to passing an FDA inspection is to understand that there are strong reaons for which an FDA inspection happens. Research organizations that want to pass an FDA inspection have to get a grasp of the factors that prompt the FDA to inspect research. These include:

  • Introduction of a new technology
  • Introduction of a new product or an indication
  • Receipts of complaints by the FDA from aggrieved parties
  • CRO being a habitual non-complier

Views: 25

Comment

You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Latest Activity

Mark Nilson posted events
2 hours ago
Training Doyens posted events
3 hours ago
Mark Nilson posted events
yesterday
gracylayla posted a blog post

What Are The Search Commands In Splunk?

The Splunk Commands are one of the programming commands which makes your search processing simple with the subset of language by the Splunk Enterprise commands. These commands are used to transform the values of the specified cell into numeric values. The following are the listed Splunk Search commands that are sorted according to the various categories.Correlation:These are one of the commands which can be used…See More
yesterday

Forum

5 TECHNOLOGY-BASED LONE WORKER SAFETY SOLUTIONS

ABOUT 75% OF EMPLOYEES IN NORTH AMERICA ARE MOBILE WORKERS. ADVANCES IN COMMUNICATIONS TECHNOLOGY MEANS THESE WORKERS CAN WORK ANYWHERE AT ANY TIME. THESE NEW TECHNOLOGIES ALSO MEAN THESE MOBILE…Continue

Tags: Solutions, People, IoT, Monitoring, Remote

Started by Jen McDade May 31.

Road Safety Solutions 14 Replies

The Road Safety Signs ,Barriers,Humps,Hazard Markers and Visual Warnings are some of the important marks to be observed. Signs such as "keep left",stop, "give way" should not be casually treated.…Continue

Tags: safety, gear, wear, Equipment, &

Started by Enna Henry. Last reply by Jen McDade May 31.

Remote Monitoring

Get "Safe Assets and Sound Productivity" Through Remote Monitoring.Visit:…Continue

Tags: Solutions, People, IoT, Monitoring, Remote

Started by Jen McDade May 23.

Python Condition Objects Tutorial in 2018 1 Reply

If you have knowledge of other programming languages, then you would know the importance of conditional statements. Conditional statements are required for taking decisions. Whenever we operate the…Continue

Tags: course, certification, training, languages, programming

Started by Elena Lauren. Last reply by Jim Chesters May 15.

Power BI Visualization Types

Visualizations in Power BI displays the visual insights from a data. In power bi service a visual can be pinned from reports to create dashboards. Visuals are used in reports.List of visualizations…Continue

Tags: COURSE, TRAINING, BI, POWER

Started by Azharuddin May 15.

Badge

Loading…

© 2018   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service