Root Cause Analysis

Root Cause Analysis is a process to perform systematic analysis to uncover the fundamental or deep-seated causes of an incident, failure or problem. What will…

Why FDA Regulatory Inspection Comes?

FDA may conduct an regulatory inspection of your operation for a variety of reasons, such as a routinely scheduled investigation, a survey, or a response…

Human Error Reduction

Human error reduction must be a primary focus of management in healthcare organizations. Human error is responsible for more than 80 percent of failures and…

Trending of Breakdown in Equipment

Breakdown maintenance is maintenance performed on a piece of equipment that has broken down, faulted, or otherwise cannot be operated. The goal of breakdown-maintenance is…

Gemba Walk In Pharma Industry

Gemba Kaizen is a Japanese concept of continuous improvement designed for enhancing processes and reducing waste. What will you learn In this course, you will learn…

How Regulators Looks at Deviations?

In pharmaceutical industry, strict compliance to approved policies and procedures is essential to keep manufacturing operations in a state of control. Uncontrolled changes like deviations…