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HVAC and GMP Environmental Control - for Pharmaceutical Clean Rooms - By Compliance Global Inc.
Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. Control of such conditions as airborne particulate, micro-organisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination.
Why Should You Attend:
It is important that a clean room’s HVAC systems are fully understood, properly designed and properly validated. If this is accomplished, it will provide the environmental control necessary to meet the regulatory particulate and micro-organism levels necessary to manufacture quality pharmaceutical product.
This webinar first details and explains the various US and international regulatory requirements for various clean room classifications.
Areas Covered in this Webinar:
- GMP Environment
- GMP Compliance of Clean Room Environment
- Regulatory Clean Room Classification and Requirements
- HVAC System Components
- Clean Room Design and Layout
- HEPA Filtration
- Differential Pressure and Air Pressure Balancing Considerations
- Temperature and Humidity Controls
- Cleaning and Disinfection
- Non-Viable Particulate Monitoring Systems
- Microbial Monitoring Systems
- Personnel Gowning and Aseptic Practices in Pharmaceutical Clean Room
- HVAC System Validation
- The design, validation and ongoing monitoring of a clean room HVAC system is necessary to assure the quality and safety of the pharmaceutical product
- A proper understanding and testing of the clean room environment according to international regulatory standards is important from a compliance perspective
Who Will Benefit:
- Quality Assurance Personnel
- Environmental Monitoring Agencies
- Microbiology Professionals
- Manufacturing Personnel
- Validation Professionals
- Engineering Professionals
- Maintenance Personnel
Roger Cowan is the founder and owner of R Cowan Consulting Services LLC, a consulting company specializing primarily in the area of pharmaceutical contract manufacturing. Roger has 36 years of experience in pharmaceutical quality assurance and manufacturing. In his career, Roger has held various manager / director positions in Quality Assurance, QC Laboratory, Technical Services Validation, Manufacturing, and Clinical Supply manufacturing and distribution.
For more detail please click on this below link:
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