Deviations and Issue Management Systems
Public / Private
Intermediate - Expert
Public Session fee
Deviations and issues such as out-of-specification (OOS) test results, rework, and product returns present a significant challenge for the pharmaceutical industry. Product recalls cost billions of dollars and erodes brand trust. Most current approaches for handling issues lack maturity, traceability, or both. These deficiencies can introduce even more risk to the quality system.
In this workshop, you will learn the best practice framework for investigating any deviation in the product’s life cycle. You will improve your ability to detect, investigate, record and report deviations as they take place. In addition, you will learn how to incorporate “risk-based thinking” into the management of issues at the point of determination. Following the taught framework, you will eliminate the root cause of each deviation and know how to implement practical corrective actions.
After the workshop, you will be able to quickly identify an issue, thoroughly investigate it, and take the right action to ensure that quality standards are met.
completing this course will help you:
Who is the training for?
This course is of particular importance to quality professionals in all GxP fields (pharma, medical devices, cosmetics, dietary supplements, and food).
If you have to deal with and investigate errors, this workshop is for you.
In a GxP environment, you must examine all issues, errors, and near-misses appropriately. That way, you can ensure that you have correctly assessed the impact and risk, assigned relevant corrective actions, and prevented future issues. This workshop will teach you how to do that most efficiently.
The topics can be adjusted and customized to your requirements.