KURSUS
Introduction to Cleaning in Pharma
This course provides a solid foundation in the key concepts and principles of cleaning processes within the pharmaceutical industry, including how adequate cleaning of equipment and facilities is documented
Kursusdetaljer
Roskilde
26. oktober 2026
Varighed: 1 dag
5.000,00 - 5.500,00 kr.
Priser er ekskl. moms
Engelsk
Effective cleaning is a critical element in ensuring product quality and patient safety.
The course material covers regulatory expectations and guidance from major authorities, including the FDA (US), Health Canada, PMDA (Japan), EMA (Europe), as well as relevant industry guidelines. Participants will gain a clear understanding of the regulatory landscape and the practical considerations involved in pharmaceutical cleaning processes.
Dissemination of contact information
Confirm
When registering for the course, your name, e-mail and telephone number will be passed on to Confirm. The contact information is used exclusively in connection withf your registration and for the course itself, but will not be used for marketing purposes.
Who should attend:
- Anyone seeking a basic understanding of cleaning in the pharmaceutical industry
- Personnel working within quality, production, or development
- New or prospective employees in the pharmaceutical industry
Cleaning in Pharma has gained increased attention from inspectors during regulatory inspections, placing higher demands on documentation related to risk assessments, deviation handling in case of irregularities during cleaning processes, and the subsequent analysis of samples. This course addresses these expectations by combining regulatory requirements with practical guidance.
Participants are encouraged to bring their own challenges and questions. The course includes case studies and hands-on exercises to support learning and practical application.
The training combines theory with practical exercises and discussions based on participants’ own experience and challenges. Participant feedback is highly valued and used to support the continuous improvement of the course.
During the course, you will gain:
- An overview of different cleaning methods and sampling techniques used to demonstrate effective cleaning
- An understanding of how acceptance criteria are established and the impact of hold times
- Insight into the difference between cleaning verification and cleaning validation
- A risk-based approach to cleaning, including deviation handling
- A brief introduction to regulatory expectations for cleaning validation
After the course, you will have:
- Reviewed applicable regulations and guidelines related to cleaning in Pharma
- Gained an understanding of key cleaning concepts and how they are interconnected
- Learned how to assess whether a cleaning process is adequate in the event of irregularities
- Gained the ability to evaluate whether the selected cleaning method and sampling technique are appropriate for a given cleaning process
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Katharina Laungaard
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