Environmental Monitoring & System Design
Risk-based Program Development * Data Trending and Analysis * Critical Utility Qualification
May 11-12, 2021
* Virtual
A risk-based environmental monitoring is a critical component for effective cleaning and disinfection programs. This virtual seminar outlines risk-based program development and implementation; data trending and analysis; and utility qualification (HVAC, clean steam and process gasses) to ensure your facility is in a state of control. Don’t’ miss industry’s EM leading experts outline the processes, tools and techniques to needed develop, implement and maintain a robust environmental monitoring program.
Top Reasons to Attend:
- Align your risk-based environmental monitoring to current regulatory expectations
- Understand the requirements set forth in the current revision of EU GMP Annex 1
- Learn the critical components of a risk-based monitoring program
- Understand the reasons behind Data Integrity issues related to environmental monitoring
- Detect deviant air to understand where real risk to product exists
- Know the common errors made when investigating environmental monitoring excursions
- Routine environmental monitoring reporting for state of control
- Understand the meaning of EM data trends
- Assess root cause and assessment of impact to product
- Set appropriate alert measures required for maintaining a state of control
- Use data analysis as part of a continuous improvement
- Understand HVAC design requirements for clean room and biocontainment facilities
- Write and document a User Requirements Specification (URS)
- Develop IQ, OQ and PQ protocols for cleanroom equipment
- Set acceptance criteria for viable and non-viable airborne particles
- Understand sampling and test location based on risk assessment
- Maintain a state of control of HVAC systems
- Implement preventative maintenance of HVAC maintaining a validated state
Personnel in the Following Environments Should Attend:
- Manufacturing
- Validation
- QA/QC
- Microbiology
- Science and Chemistry
- Cleanroom Management
- Engineering
- Regulatory Affairs
- Compliance
- Laboratory
- Facility Design
- Data Integrity and Data Management
Click Here to return to Cleaning University and register for the Cleaning University Passport which gives you access to all three (3) tracks: Cleanroom Operations, Cleaning Validation, and Environmental Monitoring
For An Additional $995, You Can Earn 1.5 Graduate Credit Hours Towards Temple’s RAQA Graduate Program! For More Information, Email INFO@KENX.ORG, Call 856-281-7134 or Register Above.