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
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Description

An Important Three Day Comprehensive & Interactive Course with Workshops and Discussions on:

- 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

Venue

Additional Information

Who should attend? This three day seminar and workshop program is directed towards Directors, Managers, Supervisors, Analysts, and Associates in the Pharmaceutical, Biopharmaceutical, Biotech, and allied industries with responsibilities in the following areas: - Quality Control - Quality Assurance - Sterility Assurance - Microbial Testing - Contamination Control - Environmental Monitoring - Cleaning Validation - Process Development - Engineering - Critical Systems and Maintenance - Manufacturing - Production - Regulatory Affairs - Training

Types