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 Compliance of Clean Room Environment
Regulatory Clean Room Classification and Requirements
HVAC System Components
Clean Room Design and Layout
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
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:
Toll Free: +1-844-746-4244