Course offering number:1004-705
Course ID:
2397
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Environmental Monitoring for Non-Sterile Drugs
In Conjunction with Wiley-Blackwell
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This online training course is intended for managers, supervisors, engineers, chemists, scientists, technicians and formulators
working within the Pharmaceutical, and related industries. It will also be valuable to documentation specialists, auditors and
those in regulatory affairs. Personnel from the following departments will find the course beneficial:
• Research and Development
• Quality Assurance and Control
• Manufacturing/Operations
• Facilities
• Finance
• IT
• Audit
• Training
• Technical Support
Description
Environmental Monitoring in Non-Sterile product manufacturing has become a current practice that encompasses
temperature, relative humidity, non-viable (and in some cases, viable) particle counts, room classifications, pressure
differentials and other environmental parameters. This 90-minute accredited training course will discuss monitoring
procedures, frequencies, alert and action limits that are needed to assure compliance.
Module 1:
• What areas need monitoring in the
non-sterile product
manufacturing facility?
• Which parameters need to be
monitored in the various
areas?
• How is this monitoring typically
carried out?
Module 2:
• What are typical monitoring
frequencies?
• Setting alert and action limits
• Avoiding pressure differential pitfalls
Module 3:
• Understanding the impact of
manufacturing personnel
on the environment and the need for training
• Auditing the environmental program
Question and Answer Session