GMP Environmental Monitoring Training Overview
Attend this GMP Environmental Monitoring Pharmaceutical webinar to various US and international regulatory requirements, the testing requirements for the various clean room classifications as well as the environmental monitoring of clean room environments. It will describe the Action and Alert Levels and how these levels are determined for a particular facility along with Corrective and Preventative Actions are defined.
Environmental Monitoring looks at the end results of the Environmental Control program – the microbiological and particulate quality of the clean room.
As the FDA Guideline on Aseptic Processing GMP (2004) states:
“In aseptic processing, one of the most important laboratory controls is the environmental monitoring program. This program provides meaningful information on the quality of the aseptic processing environment (e.g., when a given batch is being manufactured) as well as environmental trends of ancillary clean areas. Environmental monitoring should promptly identify potential routes of contamination, allowing for implementation of corrections before product contamination occurs.”
Therefore, ongoing environmental monitoring of a clean room environment is necessary to assure the quality and safety of the pharmaceutical product.
Also, a proper understanding and testing of the clean room environment according to international regulatory standards is important from a compliance perspective.
As per FDA Guideline on Aseptic Processing GMP (2004) one of the most important laboratory controls is the environmental monitoring program which provides meaningful information on the quality of the aseptic processing environment (e.g., when a given batch is being manufactured) as well as environmental trends of ancillary clean areas. Environmental monitoring should promptly identify potential routes of contamination, allowing for implementation of corrections before product contamination occurs.
Hence a proper understanding and testing of the clean room environment and ongoing environmental monitoring of a clean room environment is necessary from a product compliance perspective.
We will discuss all current air & surface monitoring systems for the measurement of non-viable particulate, microbial contaminants in the clean room . The subject of clean room contamination due to personnel is discussed including both gowning technique and aseptic practices. Then Ongoing monitoring practices for the clean room environment are discussed with respect to sampling frequency, sampling locations, and the investigation of action level excursions. This is followed by a discussion of how environmental monitoring data is reviewed (Data Trend Reports) for product release.
Why Should You Attend
This webinar first explains the various US and international regulatory requirements for the various clean room classifications as well as the environmental monitoring of clean room environments.
Next, the presentation details the benefits, the regulatory requirements and the testing requirements for a comprehensive Environmental Monitoring Program.
A description of Action and Alert Levels follows along with a discussion of how these levels are determined for a particular facility. Corrective and Preventative Actions are defined.
All current air monitoring systems for the measurement of non-viable particulate are fully reviewed.
All current air and surface monitoring systems for the measurement of microbial contaminants in the clean room are discussed in detail.
The subject of clean room contamination due to personnel is discussed. This includes both gowning technique and aseptic practices.
Ongoing monitoring practices for the clean room environment are discussed with respect to sampling frequency, sampling locations, and the investigation of action level excursions.
This is followed by a discussion of how environmental monitoring data is reviewed for product release.
Finally, a comprehensive look is taken of the current thinking about the generation and review of Environmental Monitoring Data Trend Reports.
Webinar Takeaway
This webinar will provide valuable assistance to all personnel in:
- GMP Compliance of Clean Room Environment
- Regulatory Clean Room Classification and Requirements
- Environmental Monitoring Program
- Action and Alert Levels
- Non-Viable Particulate Monitoring Systems
- Microbial Monitoring Systems
- Personnel Gowning and Aseptic Practices in Clean Room
- Clean Room Monitoring Practices - Frequency, Locations, and Investigations
- Product Release
- Environmental Monitoring Data Trend reports
Who will Benefit from GMP Environmental Monitoring Course
- Quality Assurance
- Environmental Monitoring
- Microbiology
- Manufacturing
- Validation
- Engineering
- Maintenance
Faculty Roger Cowan
Pharmaceutical Consultant at R Cowan Consulting Services LLC
Arlington, Texas, United States
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. He has 37 years 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. Roger has taught courses in microbiology at Seneca College (Pharmaceutical Technology Program) in Toronto, Canada.
