Course Description

Cleanroom Qualification and Protocol Requirements

July 14, 2020 | 11:00 a.m.–12:30 p.m. (EDT)
高h文 Online Live

Course Offering 2007902OL2931L
Course ID 2931

In-Person Course

Who Should Attend?
This online training has been developed for Personnel that work in, develop procedures for, monitor, provide technical support for, and design cleanrooms. Professionals who will benefit greatly from this training include personnel in: QA, QC
Production
Engineering
Validation
Maintenance
Architects
Development

In addition, Cleanroom Contractors and Engineers involved in designing and constructing cleanrooms will find the course extremely worthwhile.

Course Description
Failed cleanroom qualification will lead to regulatory action by the FDA, which often results in product recall. This 90-minute accredited training will provide the basic understanding of the regulations guiding cleanroom design, classification, and qualification. The training will also outline the detailed process steps required to effectively qualify a cleanroom (Commissioning, Qualification Plan and Testing Reports, Risk Assessments, DQ, IQ, OQ, and PQ). It will provide directions on the content and testing requirements for each type of Cleanroom Qualification Protocol testing and mitigation of common problems encountered.

Course Director
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 Pharmabiodevice Consulting LLC. Her consultancy provides support to Biologics, Pharmaceuticals, Radiopharmaceuticals, Biotechnology and Medical Device Industries.

Venue Information
高h文 Your Computer

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