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Why Should You Attend:
The importance of designing an effective Environmental Monitoring program cannot be overemphasized. The data from this program provides an effective measuring tool that determines an effective cleanroom controls from a Facility design, validation, implementation, disinfection, disinfectant effectiveness, gowning controls, cleanroom trafficking, aseptic controls, personnel training and practices. This webinar will you understand the requirements of an effective Environmental Monitoring (EM) program - a key determining factor of a cleanroom state of control that helps product manufacturers in preventing an inadvertent loss of product from contamination during the production process or to rule out a product contamination arising from the cleanroom facility during an investigation if an effective program is designed.
It also serves as a critical program that supports and guides other contamination control key evaluators and other production and testing processes that helps in ruling out cleanroom contamination using the data generated. This webinar will help the attendee understand the requirements of an effective Environmental Monitoring (EM) program - a key determining factor of a cleanroom state of control that helps product manufacturers in preventing an inadvertent loss of product from contamination during the production process or to rule out a product contamination arising from the cleanroom facility during an investigation if an effective program is designed. This important course will discuss various broad aspects including the relationship of the effective design of an EM program and its relationship with the Production and Process Controls per 21 CFR Parts 211.113 “Control of Microbiological Contamination” and 21 CFR Subpart G Section 820.70.
This webinar will enhance the attendee skills in the following areas:
Areas Covered in the Webinar:
Complying with the requirements of Below are specific topics and sub-topics that will be discussed:
Who Will Benefit:
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:
However, if you are already familiar with this subject, you may recommend this webinar to other professionals that may require additional knowledge about this subject.
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Charity Ogunsanya, is the CEO and founder of Pharmabiodevice Consulting LLC. Ms. Ogunsanya has over 23 years of extensive practical and management experience in various Fortune 100 pharmaceutical, biotechnology, biologics, cell therapy, diagnostics, research and development, radio-pharmaceutical, Contract Manufacturing Organization (CMO) and medical device/IVD companies.
She has been a much sought after SME to assume key roles specifically related to remediation and difficult quality and compliance related deficiencies associated with FDA’s Consent Decree, FDA’s Warning Letters and other regulatory bodies’ inspectional findings. Her remediation work has constantly resulted in several successful national and international regulatory bodies’ inspections, re-inspections and new product approvals.
Her technical expertise covers and goes beyond interpretation, administration and set up of quality assurance, quality/compliance, quality engineering, aseptic processing, contamination control, quality control, microbiology, sterility assurance, stability, vaccine development, new product design, product release testing and medical device sterilization (ethylene oxide (EtO), gamma, radiation, VHP sterilization) systems and operations for compliance to various regulations.
She has a keen working knowledge of the requirements and regulations guiding new and existing products from planning through design, proof of concept, research and development, technology transfer, pre-clinical, clinical, commercial manufacturing, supply chain, regulatory filings, pre-approval inspections, licensure, government affairs, commercialization and post-approval inspections.
She is a member of the Parenteral Drug Association (PDA), American Society of Microbiologists (ASM), and other Scientific Forums and Industry Expert Network. She has a Bachelor of Science degree in Microbiology from the University of Benin-Nigeria and she is currently attaining her Masters in Biotechnology (Biodefense Concentration) at the Johns Hopkins University Advanced Academic Program.