cGMP Controlled Raw Materials
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Instructor Profile:
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, radiopharmaceutical, 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, reinspections 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.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Why Should you Attend: CGMP raw materials are the most critical ingredient in product manufacturing; hence they must be controlled as stipulated in 21 CFR 110.80 Processes and Controls as well as applicable FDA regulations. Some drug product manufacturers have received FDA 483's and lost several batches of product due to lack of a defined raw material processing that showed acceptability through qualification tests, traceability, consistency and control of the incoming raw materials. Raw material control is therefore a very critical part that ensures drug product quality, purity and potency. Drug product manufacturers must have a clear understanding in preventing loss of expensively manufactured drug products because of the use of an adulterated raw material through a defined procedure that clearly shows how raw materials are received, stored, labeled, quarantined, tested, qualified, tracked, used, and discarded at the end of expiry. This webinar will provide such guidance as to the process of ensuring that all the steps are followed to avoid producing an adulterated product as defined by the 21 CFR 110.80 Processes and Controls. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Who can Benefit: •
Quality Control Analyst Personnel and Management
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Senior Management
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Manufacturing Associates Personnel and Management
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Facility and Utility Personnel and Management
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Quality Assurance Analyst Personnel and Management
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Vendors and Suppliers of Pharmaceutical Water Systems and Peripherals
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Regulatory Affairs and Personnel Management
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Shipping and Receiving Personnel and Management
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Materials Handling Personnel and Management
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Supplier Quality Personnel and Management
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Site Director Operations Director Others
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Live Session - How it works •
Username and Password will be sent to you 24 hours prior to the webinar
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Presentation handouts in pdf formate will be mailed to you
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Login to the session using the username and password provided to you
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Get answer to your queries through interactive Q&A sessions via chat
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Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve
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Get certification of attendance.
Recorded Session - How it works •
A link will be provided to you upon purchase of the recorded session
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Please click on the link to access the session
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Presentation handouts in pdf formate will be mailed to you
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Get certification of attendance.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com