This webinar will provide an overview of environmental monitoring investigations and tools to complete an investigation. Environmental monitoring is the method by which cleanrooms are known to maintain a certain level of cleanliness. The methods by which cleanrooms are monitored are through viable and non-viable testing. Through this testing, a room may demonstrate that it is out of control. This seminar will provide aspects to investigate and determine a root cause, as well as, appropriate actions to complete the report.
Why should you attend
Understanding how your cleanroom operates is the key to getting through inspection. An inspector expects you to conduct a comprehensive report and put the proper actions into place. This webinar will provide the tools necessary to have that comprehensive report the inspector is looking for and provide appropriate corrective actions for the various excursion types.
- International regulations (ISO)
- Federal regulation (FDA, USP)
- Non-viable testing
- Possible sources
- Viable testing
- Identification of microorganisms
- Possible sources
- Determination of a root cause
- Corrective and Preventative Actions to put into place
- Provide background information on regulatory guidance on environmental monitoring.
- Provide background information on environmental monitoring methods for viable and non-viable testing.
- Correlate non-viable and viable results with the appropriate environmental monitoring controls.
- Provide possible sources of contamination and possible corrective actions.
- Provide possible preventative actions in order to prevent future contamination
- Provide case studies on contamination events.
Recorded Version will be available within 24 hours after completion of the live Webinar and will allow unlimited viewing for 3 months.
CD Version can be dispatched after 72 hours on completion of live Webinar.
QA Specialist ,
Carl Patterson, M.S. has completed twelve plus years in the biotechnology, pharmaceutical manufacturing and quality fields. He completed his Bachelor's of Science in Microbiology from the University of Texas. Also, has completed specialized certificates in biotechnology manufacturing, quality control, and quality assurance from UCSD, and has completed his Master's of Science in Biomedical Quality Systems from SDSU. Through the years, has worked with several companies in regards to aseptic processing and has helped to insure the expectations, related to aseptic processing, have been met.
Who will Benefit
- Pharmaceutical Manufacturing Companies
- Contract Manufacturing Companies (CMOs)
- Personnel Involved with Environmental Monitoring Operations
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.