Course Description
This 1-day course is designed for professionals in the pharmaceutical industry who are new to cleaning validation. It provides a solid introduction to the principles, regulatory expectations, and practical approaches to cleaning validation. The course is conducted in English and requires no prior experience with cleaning validation.
Who should attend
- Production Support/Specialists transitioning to QA or Validation
– Need to learn about regulatory requirements and validation principles. - New QA Specialists
– Require understanding of GMP requirements and cleaning documentation. - R&D Staff transferring processes to GMP environments
– Need insight into cleaning requirements during scale-up. - Consultants or new employees in consultancy firms
– Must quickly gain understanding of cleaning validation to advise clients. - Regulatory Affairs Professionals
– Need to understand the rationale behind documentation and submission requirements. - Technicians and Engineers in Maintenance or Equipment Design
– Must know cleaning requirements and design principles for cleanability. - Operators
– Perform cleaning procedures and need to understand their purpose and regulatory expectations. - Managers (e.g., QA/QC/Production/Validation Managers)
– Require an overview of regulatory requirements and risk-based approaches and must be able to understand and approve validation strategies and communicate with specialists.
Outcome
This 1-day course provides a structured and practical introduction to cleaning validation in the pharmaceutical industry. Participants will gain a foundational understanding of how cleaning validation supports GMP compliance and product safety, and how to apply regulatory expectations in a risk-based and scientifically justified manner.
The course covers key regulatory guidelines from EMA, FDA, and ICH, and introduces tools for developing a cleaning validation strategy, selecting appropriate sampling methods, and explains acceptance criteria. Through a combination of lectures, exercises, and case-based learning, participants will get an introduction on how to plan, document, and evaluate cleaning validation activities effectively.
You will learn about
- GMP and cleaning validation – background and connection
- Basic concepts and types of cleaning
- Regulatory requirements (EMA, FDA, ICH)
- Risk management and worst-case approach
- Validation strategy and acceptance criteria (MACO, PDE, visual)
- Sampling methods (swab vs rinse), recovery studies, and method validation
- Case study and hands-on exercises
Course Features
- Theoretical presentations
- Interactive exercises and reflection
- Case study from an inspector’s perspective
- Time for questions and discussion
Trainer
Nadja Schultz-Jensen, Senior Consultant, Pharma4ever
