Scope
The course addresses environmental monitoring for the manufacturing of both sterile and non-sterile products. It looks at the legislation and guidance available, techniques employed to monitor pharmaceutical environments, data trending and how to manage out of limit results. Additionally a review of risks associated with contamination sources, monitoring methods, trending and reporting of results is undertaken.
Suitability
This course is aimed at personnel in production and quality functions who wish to increase their understanding of regulatory requirements and expectations for the environmental monitoring of pharmaceutical operations. It will be of particular use to anyone performing environmental monitoring and those involved in collating and interpreting the results obtained.
Learning outcome
By the end of the course you will:
- Understand the testing techniques regularly used in pharmaceutical production operations
- Know what factors to consider when developing an environmental monitoring programme appropriate for your operations
- Know how to interpret results and identify trends
