This course of four chapters will give you a sound basis of the regulatory requirements expected of a good pharmaceutical cleaning process, how to calculate limits and their justification. The pros and cons of various cleaning methods and how to approach them. Finally, how to plan and approach a validation exercise with specific cleaning acceptance criteria.
Upcoming start dates
- Self-Paced Online
Outcome / Qualification etc.
By completing/passing this course, you will attain the certificate of Completion.
Training Course Content
To discuss and review:
- Regulatory expectations for cleaning validation
- EudraLex chapters 3 and 5
- Annex 15 requirements
- Health-based exposure limits, how they are determined, the data needed to support these limits and what the health-based exposure limit is used for with regards to cleaning qualification
- Different approaches to the qualification and potential validation of manual and automated cleaning procedures
Why choose NSF International, Health Sciences
Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course
Provided expert health sciences training for over 30 years
More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider
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Average rating 5
Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.