Environmental Monitoring (EM) in Pharmaceutical Manufacturing
Venue: New Jersey
Location: New Jersey, Antigua & Barbuda
Event Date/Time: Mar 18, 2008 | End Date/Time: Mar 20, 2008 |
Description
- GMP requirements for environmental
monitoring (EU, US 21CFR)
- Cleanroom Testing and Monitoring
- Microbiology of Environmental Monitoring
- Environmental Monitoring in Non-Sterile
Manufacturing
- Applying a Risk Approach to Environmental
Control Issues
- Designing and Implementing an Effective
Cleaning and Disinfection Program
- Risk Based Approach to Environmental
Monitoring
- Components of the Cleaning Validation
Protocol
- Statistics for Cleanroom Testing and
Monitoring
- Cleanroom Monitoring in Compliance with ISO
14644-1 (ISO 14644-2)
- Airborne Particle Count Testing
- Troubleshooting Microbial Excursions in
Pharmaceutical and Biotech Facilities
- Statistics for Cleanroom Testing
- Electronic Environmental Monitoring Data
Management System
- Addressing Out-of-Specification (OOS) Events
and Excursions
- Conducting Root Cause Analysis and CAPA in
Environmental Monitoring
- Auditing of Aseptic Processing Operations
- GMP and Quality System Regulations for Water
Systems
- Comparison of Water Purification Techniques