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When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.
Learn moreRemember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.
Determining a Cleanroom State of Control
The importance of designing an effective Environmental Monitoring (EM) program cannot be overemphasized. The data from this program provides an effective measuring tool that determines an effective cleanroom control from a Facility design, validation, implementation, disinfection, disinfectant effectiveness, gowning controls, cleanroom trafficking, aseptic controls, personnel training, and practices. It also serves as a critical program that supports and guides other contamination control key evaluators and other production and testing processes that help in ruling out cleanroom contamination using the data generated.
This 90-minute ON DEMAND accredited training will discuss the various steps associated with the EM program from the Phases, through Validation, Implementation, Procedural Steps, Documentation Practices, Data Management, Trending of Data, EM Excursion, and the relationship of the cleanroom state of control and product impact and analysis per 21 CFR Parts 211.113 Control of Microbiological Contamination and 21 CFR Subpart G Section 820.70.
This 90-minute ON DEMAND training will provide a great resource to product manufacturers with personnel in the Pharmaceutical, Biotechnology, Biologics, Drugs, Diagnostics, Cell Therapy, Medical Device, In-vitro Diagnostics industries within the following functions:
– QA/QC
– Microbiologist
– Facilities
– Chemist
– Analysts
– Manufacturing
– Validation
– Material Management
– Engineering
– Vendor/Suppliers
– Regulatory Affairs
– All Levels of Management
Charity Ogunsanya
(Owner/CEO), Pharmabiodevice Consulting LLC
Charity Ogunsanya has more than 30 years of extensive experience within the Biologics, Pharmaceuticals, Radiopharmaceuticals, Biotechnology and Medical Device Industries and has been the Microbiology, Sterility Assurance, Contamination Control, Aseptic processing, Quality Control Subject Matter Expert (SME) for multiple fortune 100 companies.
She has a Bachelor of Science degree in Microbiology from the University of Benin-Nigeria and has a Masters degree from the Advanced Academic Master's Biotechnology Program at the Johns Hopkins University with concentration in Biotechnology/Biodefense. She is the CEO/ Owner of her consulting firm named Pharma biodevice Consulting LLC. Her consultancy provides support to Biologics, Pharmaceuticals, Radiopharmaceuticals, Biotechnology and Medical Device Industries.