a biotechnology-based manufacturing business-training enterprise vivian ngan-winward, chloe...
TRANSCRIPT
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- A Biotechnology-based Manufacturing Business-Training Enterprise Vivian Ngan-Winward, Chloe Cigarroa, Mary Nelson BIOMAN 2014 July 14-17 DUE-1003292 1
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- Purpose Create a regulated / GMP training environment Offer industry-relevant practical training Manufacture products that support / enhance biotechnology instruction 2
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- Product Lifecycle Idea Research & Developme nt [Proof of Concept] Prototyping / Pilot Plant [Validation & Smaller Scale Production] Manufacturi ng [Mass / Large Scale Production] Consum er 3 Regulations GMP
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- Customers 1. Student interns 2. Buyers of product & their students 4
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- In the Beginning... A collaboration Biomanufacturing / Biotechnology Accounting Business Management Marketing Faculty mentors & student interns 5
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- First Products Cheek cell DNA extraction kit Assessment plasmid coded unknown samples 6
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- Lessons Learned Student work pace = slow ! Student enrollment low Business students/faculty do not understand biotechnology Cost-effective instructional supplies vs. business philosophy differences 7
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- STUDENTfacturED 2.0 School of Business withdrawal Partnership with InnovaBio = product development (R&D) = manufacturing Full quality management system Based on ISO 13485 (for medical device) Facilitates GMP compliance MasterControl : management software 8
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- Whats Happening Now Partnership = Restructuring Director of InnovaBioDirector of STUDENTfacturED InnovaBio full-time staff (2) InnovaBio student interns InnovaBio part-time staff STUDENTfacturED full-time staff (1) STUDENTfacturED student interns 9 R&D Manufacturing
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- Whats Happening Now QMS Completion a la ISO 13485 10 Quality Manual Documen t Control Design Control Nonconfo rmances Quality Event Mgmt / CAPA Complaint Handling Risk Assessmt / Mgmt TrainingAudits Supplier Mgmt
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- Whats Happening Now QMS show & tell Quality manual Design Control SOP & Form 11
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- Whats Happening Now New product development under design control per 21 CFR 820.30 12
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- New Product DNA ladder 2-log ladde r * bp: 500 400 300 (2x) 200 100 New ladde r 13
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- MasterControl Software Management of Documents Training Suppliers Changes Nonconformances / complaints CAPA Audits Risk 14
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- Next Steps Curriculum adjustments New product ideas Logistics for product sales ??? 15