Course offering number:1008-711
Course ID:
2427
Operation of the Clean Room (Third in a Three Part Series)
In Conjunction with Medical Device Summit
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This course is intended for all personnel involved with the following areas of pharmaceutical and medical device sterile facilities:
• Design
• Construction
• Validation
• Operation
• Monitoring
Other personnel who will find this course of interest:
• Design Engineers
• Test Contractors
• Equipment Manufacturers
• QA/QC
• Regulatory Affairs
• Production
• Maintenance
Description
This 3-part online training series reviews the current state of the technology associated with pharmaceutical, medical device, active
pharmaceutical ingredient, medical component, R&D, and microbiological clean rooms.
Each session of the series may be taken individually. However, for the maximum training benefit, you are encouraged to attend the complete
three part presentation. Register for all 3 parts and save $150!
The courses in the series are:
Clean Room Technology Basics in a Nutshell (First in a Three Part Series)
ID# 2420 Course offering: 1008-709
Microbiology Fundamentals Relating to Clean Rooms (Second in a Three Part Series)
ID# 2426 Course offering: 1008-710
Operation of the Clean Room (Third in a Three Part Series)
ID# 2427 Course offering: 1008-711
This 90-minute accredited training will focus on developing procedures for monitoring the various classifications of clean rooms as well as how
to address a monitoring specification failure. It will also address procedure for personnel activity in the clean rooms as well as gowning practice
and training. Tips on how to effectively audit the clean room associated activities will also be covered.
Module 1:
• Room classifications (EU,US,ISO)
• Typical activities carried out in the various classifications
• Monitoring programs for each room
classification
Module 2:
• Personnel Training
– Gowning
– Clean room behavior
Module 3:
• Typical deviations
• Investigating and correcting deviations
• Auditing tips
Question and Answer Session