We will discuss various US and international regulatory requirements, testing requirements for environmental monitoring program, current air and surface monitoring for measurement of no-viable particulate, microbial contamination, contamination due to personnel (gowning techniques and aseptic practices), ongoing monitoring practices with reference to sampling frequency, sampling locations and investigation of action level excursions and monitoring data.
Why Should You Attend
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.
Attend this 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.
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.
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
• Quality Assurance
• Environmental Monitoring
Industries who can attend
This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel