Deviations and Issue Management Systems
Public / Private
SESSION TYPES
Virtual Class
Location
Intermediate - Expert
Skill Level
~8-10 Hours
Duration
€750
Public Session fee
(PER PERSON)
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Course:
Overview
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:
- document deviations quicker and more effectively,
- drive continual improvement to your systems,
- reduce the number of reoccurring deviations
- minimize the number of overdue deviations in the system
- become more effective and reduce stress.
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.
Topics
The topics can be adjusted and customized to your requirements.
- The deviation investigation Process
- How to correctly document deviations
- How to perform effective Impact/Risk assessment
- How to efficiently investigate events
- How to design effective CAPAs and follow-ups
- How to implement a n effective Deviation/investigation process
About the trainer
Alex Hall
Alex is an expert in Pharmaceutical Quality Assurance with 30 plus years in the pharma industry, 20 of those as a Qualified Person. As an instructor, Alex builds on her experience and her previous role as a UK QP Assessor to support QA professionals and QP trainees. She helps trainees achieve the best results through supportive coaching, mentoring, and a straightforward training approach.
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