The Zebrafish Model

EPA Develops Approach to Screen Air Pollution Sources Related to Heart Health

Particulate matter (PM) is a main component of air pollution, and can affect heart health. The EPA is continually taking steps to develop an approach to rapidly assess the cardiotoxicity potential of PM from different sources, and are calling the approach “Pathfinder Innovation Project (PIP)”. Many innovative approaches have been developed, including the use of…

Document Control

Both FDA’s 21 CFR 820 and ISO 9001 have requirements for document control.  The goal with this section of the standards is to demonstrate that your quality system is compliant, that you design and manufacture products to meet design controls, and that your company is addressing risk management concerns.  The FDA typically takes the approach…

Quality Policy

Another item that is required by both 21 CFR 820 and ISO 9001 is the Quality Policy.  Though it is jointly written by management and quality experts, the process of writing a Quality Process is a beneficial exercise for management as it has them focus on systems and how the company operates.   This document…

Why Calibration Matters

The concept of equipment calibration is an important one throughout FDA and ISO requirements.  ISO 9001, section 7.6 discusses it in a broad sense, while ISO 17025, “General Requirements for the Competence of Testing and Calibration Laboratories”, is specifically about calibration.  In 21 CFR 820.72, it’s stated that “Calibration procedures shall include specific directions and…

Preventive Maintenance

Preventive maintenance is a concept that includes care and servicing of equipment for the purpose of keeping equipment in a satisfactory operating condition.  It is designed to improve equipment life and avoid any unplanned maintenance activities.  This is accomplished through a systematic inspection, detection and correction of any developing failures before they occur.  Preventive maintenance…

Methods for Supplier Evaluation

There are a number of ways to conduct an evaluation of your suppliers.  To begin with, many organizations create a survey in which they outline various questions pertaining to quality systems.  Some companies consider ISO 9001 certification to be the best representation of control over production and quality, and therefore will evaluate the supplier based…

Quality Plan

In 21 CFR 820 Subpart B, the FDA states “Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured.  The manufacturer shall establish how the requirements for quality will be met.” A quality plan states the goals your company has to improve…

FDA Inspections

If your company holds a 510(k) on a device, the FDA may perform an inspection of your facility for any number of reasons including routinely scheduled investigations or response to a reported problem.  These inspections are supposed to happen at least once every two years.  There is no requirement, though, for the FDA to give…