Summary
Handling deviations effectively is critical for product quality, patient safety, regulatory compliance and continuous improvement in the pharmaceutical industry. Many organisations struggle to identify the true root cause of deviations and implement effective corrective actions. As a result, deviations often recur.
This two-day course gives you a practical understanding of deviation management and root cause analysis in the Pharmaceutical and MedTech industry. The course gives you the knowledge and practical tools to identify, investigate and resolve deviations in line with GxP and MDR requirements.
You will learn how to support product quality, patient safety, continuous improvement and regulatory compliance in the pharmaceutical and MedTech industry in the EU and US.
The course combines theory, practical workshops and an introduction to the regulatory requirements for deviation handling and root cause analysis.
You will work hands-on with different root cause analysis tools and learn how to strengthen deviation management and support continuous improvement.
Key words
- Deviation Handling
- Root Cause Analysis
- GxP
- MDR
- Pharmaceutical and MedTech industry
Save information for later
Course leader & lecturers
- Lone JespersenCourse leaderSenior QA Specialist
Niras
Watch the video
Is this course for you?
This course is for you if you work within the Pharmaceutical and MedTech industry and are involved in deviation handling and root cause analysis in your daily work.
Particularly professionals like managers and specialists working within QA, QC, RA, Manufacturing, Validation, Supply Chain and Pharmacovigilance.
What you will learn
- Understand regulatory expectations for deviation handling and apply them with confidence in daily work.
- Use practical root cause analysis tools to identify true causes and prevent recurring deviations.
- Strengthen investigations with structured problem-solving, clear documentation and ALCOA++ principles.
- Define effective CAPA actions that support product quality, patient safety and compliance.
- Turn deviation management into business value through stronger processes and continuous improvement.
What your company will get
- An employee who can run stronger deviation investigations that address true root causes and reduce repeat issues.
- An employee who can ensure more consistent GxP- and MDR-aligned handling of deviations across teams and functions.
- An employee who can deliver better CAPA quality, supporting product quality, patient safety and inspection readiness.
- An employee who can improve documentation and data integrity through structured investigation practices.
- An employee with a stronger continuous improvement mindset who turns deviations into measurable business value.
Course calendar
Day 1
- Regulatory Requirements for Deviation Handling
- Deviation Flow
- Workshops, Root Cause Analysis (RCA) Tool
- Correction, Corrective and Preventive Action (CAPA)
- Fishbone diagram
- 5 x Why
Day 2
- Workshop - Root Cause Analysis (RCA) Tool
- A3 – PDSA Tool
After Root Cause Analysis (RCA)
- CAPA and effectiveness
- Repetitive deviations
- Continuous improvement
Business value or not?
- Deviation handling in the future
Registration
Registration deadline25 Jan 2027
Lersø Parkallé 101
2100 København Ø
13,000 DKK
Course information
Literature
Prior to the course you get access to mandatory and/or optional readings via your personal Atrium log-in.
Prerequisites
Examination
There is no examination for this course.
Course leader
Niras
Lecturer
Niras
You may also be interested in these courses
5 Apr 2027
•
•
Want to know more or need help?
Contact Client Manager Louise V. Petersen at +45 40 44 99 43
Send me a message