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CfPA-The Center for Professional Advancement, 90 Minute Accredited Online Training
July 21, 2015 at 11:00 a.m.–12:30 p.m. (ET)
Who Should Attend?
This webinar will provide a great resource to Pharmaceutical, Biotechnology, Biologics, Drugs, Medical Device, In-vitro Diagnostics Industry personnel within the following functions: Quality Control, Quality Assurance, Microbiologist, Chemist, Analysts, Manufacturing, Validation, Facilities, Materials, Engineering, Vendors/Suppliers, all Technical Writers and SOP/STM Users, Regulatory Affairs and all levels of management. Course Description
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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 (CEO/Founder), Pharmabiodevice Consulting LLC |
Charity Ogunsanya has more than 24 years of extensive experience within the Biologics, Pharmaceuticals, Radiopharmaceuticals, Biotechnology, Cell Therapy, Diagnostics, Drug and Medical Device Industries and has been the Microbiology, Sterility Assurance, Contamination Control, Aseptic processing, Quality Control subject matter expert 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 Biodefense. She is the CEO/Founder of Pharmabiodevice Consulting LLC. The consultancy provides Quality and Compliance consultancy/support to Biologics, Pharmaceuticals, Cell Therapy, 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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Designing an effective Standard Operating Procedure (SOP) and Standard Test Method (STM) is the pre-requisite to complying with the different regulations guiding the manufacturing and testing of products. A well-established procedure and test method improves the numbers of manufacturing, testing and personnel deviations which indirectly affects the quality and life cycle process of a manufactured product.
This 90-minute accredited training course will provide the attendee the ability to understand the sequence of designing, development, drafting, processing and approval of an effective and compliant SOP or STM. The industry applications, regulations, content, organization, development, management process/cycle, content and formatting of an SOP and STM will be discussed. Understanding these requirements will aid in the reduction of manufacturing and testing errors arising from an unclear, poorly planned/executed and vague procedures that are left to several varying interpretations and applications which may sometimes lead to non-compliance.