CfPA-The Center for Professional Advancement, 90 Minute Accredited Online Training
May 7, 2015 at 11:00 a.m.–12:30 p.m. (ET)
Who Should Attend?
This webinar 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:
Quality Control, Quality Assurance, Microbiologist, Facilities, Chemist, Analysts, Manufacturing, Validation, Facilities, Materials Management, Engineering, Sterility Assurance, Compliance, Testing Technicians, Environmental Testing Personnel, Raw Materials Manufacturers, Clinical, Research and Development, Laboratories, Vendors/Suppliers, Regulatory Affairs and all levels of management. Course Description
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Invited Speakers:
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| Charity Ogunsanya (CEO/Founder), Pharmabiodevice Consulting LLC |
Charity Ogunsanya has more than 24 years of extensive experience within the Biologics, Pharmaceuticals, Radiopharmaceuticals, Biotechnology, Cell Therapy, Diagnostics, Drug and Medical Device Industries and has been the Microbiology, Sterility Assurance, Contamination Control, Aseptic processing, Quality Control subject matter expert for multiple fortune 100 companies. She has a Bachelor of Science degree in Microbiology from the University of Benin-Nigeria and is currently in the Advanced Academic Master’s Biotechnology Program at the Johns Hopkins University with concentration in Biodefense. She is the CEO/Founder of Pharmabiodevice Consulting LLC. The consultancy provides Quality and Compliance consultancy/support to Biologics, Pharmaceuticals, Cell Therapy, Radiopharmaceuticals, Biotechnology and Medical Device Industries.
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This 90-minute accredited training will discuss various broad and critical aspects of an effective EM program such as the Phases of a cleanroom EM Program–Pre-Monitoring of a Cleanroom prior to Facility Validation, Facility Validation, Implementation of Routine EM using Facility Validation data and Post-validation. Procedural Steps, Content of a robust EM program such as handling, incubation, Documentation, Management and Trending of Data, EM Excursion investigation and Product Impact and Disposition will be discussed.