Master the essentials of quality control in Medical Device and Pharma production
In this course, you will gain the knowledge and practical skills to perform quality control in production environments within the Medical Device and Pharmaceutical industries.
You will learn to meet the regulatory requirements for sampling plans, sample testing, and reporting while developing a strong understanding of specifications, drawings, and documentation – essential tools for ensuring product quality and compliance.
The course is conducted in accordance with the Medical Device Regulation and related ISO standards, with an interface understanding of GMP (Good Manufacturing Practice). You will also be introduced to basic calibration and validation principles, including measurement uncertainty calculations.
By the end of the course, you will be able to perform various control measurements, operate different types of measuring equipment, and consult relevant ISO standards. You will work with technical drawings and understand how to apply them in quality control of production, processes, and products.
Course Content
- Understanding of the principles and procedures for quality control in production.
- Insight into the Medical Device Regulation and relevant ISO standards.
- Knowledge of sampling methods, testing, and documentation requirements.
- Familiarity with measurement tools, calibration, and basic validation concepts.
- Interpretation and use of technical drawings related to inspection and control work.
Target Group
This course is designed for employees in the pharmaceutical or medical device industry — or for those who wish to pursue a career in these sectors. It is ideal for professionals working with production, testing, or quality assurance who need to understand and apply quality control principles in practice.
Certificate
Upon successful completion and passing the final test, you will receive an AMU competence certificate that documents your new qualifications in quality control.