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.Instructor Profile:
Charity Ogunsanya has over 26 years of extensive experience within the Pharmaceutical, Biotechnology, Biologics, Cell-Therapy, Diagnostics, Research and Development, Radio-pharmaceutical, Contract Manufacturing Organization (CMO) and Medical Device companies.
Throughout her corporate career within these diverse industries, she held various high visibility and business critical roles within the Quality and Compliance division in major Fortune 100 companies both as a Subject Matter Expert (SME), Site Manager, Multi-site Manager and Director Levels receptively. She has been a sought after expert and have been consistently hired after several competitive efforts by major fortune 100 companies 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 difficult regulatory bodies inspectional findings which is always achieved with a successful outcome. She has also been a sought after expert by various companies requesting her expertise as a known industry expert to specifically assume roles in order to perform a total overhaul, restructure, compliance remediation, re-organization, start-up processes related to Quality Systems improvements and/or enhancements. In all cases, her remediation work resulted in several successful National and International regulatory bodies’ inspections, re-inspection and new product approvals.
Her technical expertise are not limited to the 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.
Ms. Ogunsanya is vast in 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. Her expertise has been sought after by several Fortune 100 Pharmaceutical, Biotechnology, Biologics and Medical Device companies as a Quality and Compliance SME during critical national and international regulatory bodies’ routine and new product approval inspections.
She is the CEO of Pharmabiodevice Consulting LLC (www.pharmabiodeviceconsultant.com) targeted towards Quality and Compliance related remediation, enhancements and consultant services for various companies within the industry. She is a well sought after high level consultant for several international professional expert networks such as Gerson Lehrman Group, Zintro Expert Network and Intota Expert Network. She is a member of the Parenteral Drug Association (PDA), American Society of Microbiologists (ASM), and other Scientific Forums and Industry Expert Network.
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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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