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When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.
Learn moreRemember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.
Designing, Development, Drafting, Processing and Approval of An Effective and Compliant SOP or STM
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 ON DEMAND 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.
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
– All levels of management
Charity Ogunsanya
(Owner/CEO), Pharmabiodevice Consulting LLC
Charity Ogunsanya has more than 30 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 has a Masters degree from 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 Pharma biodevice Consulting LLC. Her consultancy provides support to Biologics, Pharmaceuticals, Radiopharmaceuticals, Biotechnology and Medical Device Industries.