Summary
Robust change control is essential for pharmaceutical quality systems and safeguards product quality, patient safety, and regulatory compliance by rigorously evaluating, approving, and documenting all changes.
This course gives you a structured and practical understanding of change control processes across the product lifecycle, from development to commercial manufacturing.
You gain insight into regulatory requirements (GxP/MedTech), learn how to classify and assess changes, and understand how to integrate change control with deviations, risk management, validation, and CAPA systems. Through real-life examples, case discussions, and interactive exercises, you develop the competencies required to manage changes effectively and avoid common pitfalls such as inadequate impact assessments, poor documentation, and delayed implementation.
Key words
- Change control
- Quality systems
- EU GxP EudraLex Volume 4
- QA
- QC
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Course leader & lecturers
- Steen ArnesenCourse leaderConsultant Life Science
Niras
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Is this course for you?
This course is for professionals working within the Pharmaceutical and MedTech industry who are involved in change control in their daily work.
Particularly professionals like managers and specialists working within QA, QC, RA, Manufacturing, Validation, Supply Chain will benefit from this course.
What you will learn
- Ensure compliant and efficient change control aligned with regulatory requirements
- Integrate change control with CAPA and continuous improvement to strengthen the QMS
- Enable clear, ALCOA++-compliant documentation and decision-making
- Apply a risk-based approach with structured impact assessment and mitigation
- Deliver measurable business value through effective and sustainable change implementation
What your company will get
- An employee who can ensure compliant change control, resulting in fewer audit findings
- An employee who can integrate with CAPA and CI, leading to a stronger QMS
- An employee who can enable ALCOA++ documentation, supporting better decisions
- An employee who can apply a risk-based approach, reducing risk and deviations
- An employee who can drive effective implementation, delivering measurable efficiency gains
Course calendar
Day 1
- Regulatory requirements for change control
- Change control flow
- Change definition and classification
- Impact assessment
- Risk assessment
Day 2
Workshop day
- Implementation planning
- After change implementation
- Business value or not?
Registration
Registration deadline1 Mar 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.
Examination
Course leader
Niras
Lecturer
Niras
Want to know more or need help?
Contact Client Manager Louise V. Petersen at +45 40 44 99 43
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