Successful cleaning validation ensures that patients are not put at risk due to cross contamination during production. Cleaning validation is recognized as the most important activity as it has a direct effect on patient safety and drug quality. As it has adverse effects, the global regulatory authorities are keeping a close check on pharmaceutical companies.
Compliance with current regulatory expectations with respect to cleaning is in flux, regulation changes in the past few years have resulted in companies being cited for poor compliance of their cleaning approach. This course will summarize the current expectations and how these can be met in a pragmatic and practical manner.
This course will provide a concise, pragmatic approach to cleaning – it will provide you with an overview on how you can apply this to your own activities and assess your own process vulnerabilities. Using examples and applications from across the industry you will learn the correct approach whilst also formulating your own compliance plans to take forward.
Suitability - Who should attend?
This course is ideal for you if:You are responsible for process improvement in your team and need help with the approach - You have had issues with your deviations raised in your latest (and previous) inspections – issues that have not been investigated fully or repeat issues - You are committing a lot of time and effort on investigations but not truly addressing the issues you are finding
Training Course Content
By the end of this workshop participants will: