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CfPA - The Center for Professional Advancement, 90 Minute Accredited Online Training
December 17, 2013 at 11:00 a.m.–12:30 p.m. (ET)
Who Should Attend
This webinar will provide a great resource to the Pharmaceutical, Biotechnology, Biologics, Drugs, Medical Device, In-vitro Diagnostics, Food and Compounding Pharmacies product manufacturers with personnel in the following functions: Manufacturing, Quality Control, Quality Assurance, Stability Program Coordinator, Managers, Microbiologist, Chemist, Analysts, Validation, Materials Management, Regulatory Affairs and all levels of Management.
However, if you are already familiar with the requirements of a contamination control requirements, you may recommend this webinar to professionals within the various industries that may require additional knowledge about this subject. Description
This course will be available On Demand: December 18, 2013
An aseptically manufactured product does not require a further sterilization process hence designing and implementing an effective production and process controls improves the sterility assurance of a manufactured product. Loss of a manufactured batch of product, raw materials, API and excipients as well as product complaints and/or recall arising from microbial contamination is expensive, impacts the manufacturing company, impacts the business profits and margins, unsafe to the end user, will be deemed to be adulterated per guidance and regulations and it is a recipe for an unexpected regulatory audit, warning letters, fines and/or a manufacturing site shut down by the FDA. Understanding the 6 key elements of designing an effective contamination control program will help in achieving a high level of compliance to 21 CFR Parts 211.113, related FDA’s, national and international regulatory bodies’ guidance and regulations. Achieving a low bioburden level is also critical in the determination and sustainability of the relevant sterilization processing parameters associated with the initial development, validation, revalidation, qualification, requalification and routine processing of Medical Devices sterilization processes.
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Organized by:
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CfPA - The Center for Professional Advancement |
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Invited Speakers:
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Charity Ogunsanya; (Owner/CEO), Pharmabiodevice Consulting LLC
Charity Ogunsanya has more than 23 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 is currently in 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.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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sberg@cfpa.com
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