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Courtland Imel
Welcome, I am Courtland Imel, CEO of Ceutical Labs and Consultant to Drug/Device/Cosmetic/Nutraceutical Industries
Courtland Imel Senior Consultant role within Pharmaceutical or Medical Device company n Skilled executive within regulated environment. Thirty years of USFDA-regulated environment, twenty five years of pharmaceutical and medical device experience and twenty years of management experience in project management, quality, validation and regulatory affairs. n Financial Impact · Developed new business from existing medical device hydrogel pad product with initial worth of $6MM · Established liquid drug product filling and packaging business worth $10MM in first year for medical device company · Wrote and submitted two successful 510(K)’s for new product revenues of $25MM for first year for drug delivery devices. · Developed new radiolabeling technology that reduced cost of medical device from $34 per unit to $2.25 per unit. · Wrote and championed contracts worth approximately $10 MM for drug development for contract radiological manufacturer. · Developed mercury disposal system that saved company $65,000/month. · Maintained budgets exceeding $3MM, capital budgets exceeding $1MM, and signature authority of $60,000. §Managed project teams in excess of 250 people, managed scientific teams of 32 people (B.S. to PhD). Managed six major building projects with no to minimal manufacturing downtime. Managed direct personnel with functions that included raw material, in-process, finished product, toxicology, clinical, bulk chemical, stability, and microbiology testing, manufacturing, product development, marketing, and project management. §Successful project management skills for pharmaceuticals and medical devices from concept to commercialization. Successful customer, supplier, and contract relations. Established customer presentations to highlight company capabilities to obtain large contracts. §Established quality systems within each employer through SOP’s, audits, training, and validation programs. Established quality standards to meet 21CFR11, 21CFR210/211, 21CFR820, OSHA1910, ISO9000, and ISO13485. Validation programs include master, facility, process, equipment, cleaning, software, hardware, and technology transfer protocols. §Successful compliance record with USFDA; foreign Ministries of Health that include MCA, Canada, Germany, and Ireland; NSAI, TUV, BSI, and Amtak/Intertek. Led or participated in 16 USFDA audits, 9 ISO audits, 7 foreign ministry audits, 4 radiation safety audits, 5 state health department audits, 2 Oliver Wright Operational Excellence audits, and numerous customer audits. §Equipment qualifications have included analytical laboratory equipment for chemistry and microbiology, chambers, network systems, computers, and software. Specific chemistry testing equipment includes HPLC, GC, FTIR, NIR, UV/Vis, ICP, and AAS.