Audience

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.

Duration

1 day

Objectives

The course covers the following topics:
• Introduction and Background
• Testing Techniques
• Developing a Program
• Workshop - Identifying risks
• Calculating Compliance Limits
• Interpreting Results
• Workshop - Identifying Trends
• Identification

Content

Run in partnership with Environmental Monitoring & Process Validation Specialists, Cherwell Laboratories, 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. The course agenda includes Technical Representatives from Cherwell explaining Microbial Air Sampling options, implementation aspects and also a tour of Cherwell's manufacturing facility.

Cost

Non-Member - £695 + VAT
One Nucleus Member* – £556 + VAT 

*Please email training@onenucleus.com for the ON member discount code.

Training provided by

Tel: 0118 918 4076
Email: bookings@rssl.com