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Meet The Team
Co-Founder and Principal Consultant
Lesa Smith
Lesa is the owner of QA Concepts, LLC and is based out of Utah. Lesa has 30+ years of experience in the pharmaceutical and medical device industries and has expertise in Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Pharmacovigilance (PV) and Good Clinical Laboratory Practice (GCLP).
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Lesa has experience in the following therapeutic areas: Oncology, Vaccines, Cardiovascular, Metabolic, Pulmonary, CNS, Pain, Dermatology, Women's Health and Cell and Gene Therapy.
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Lesa is experienced in pharmaceutical, device and combination products, including GCP Audits, Contract Manufacturing Audits, GMP Facility, Active Pharmaceutical Ingredient (API), Actual Use Trial and Container Closure Study audits.
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Lesa has worked at multiple pharmaceutical companies throughout her career, including small biotech and top pharmaceutical organizations. Lesa worked at Pfizer, prior to starting her own consulting company. QA Concepts was founded in 2007.
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Lesa has audit and quality support experience in the following Regions:
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United States
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Canada
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South America
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Europe
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Eastern Europe
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Asia
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Middle East
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Africa
Lesa has regulatory authority experience with the following:​
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US FDA – Sponsor and Investigator Site Inspections. GMP Inspections.
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Health Canada – Sponsor and Investigator Site Inspections. GMP Inspections.
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UK MHRA – Sponsor Inspections and Investigator Site Inspections. GMP Inspections.
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EU EMA – Sponsor Inspections and Investigator Site Inspections. GMP Inspections.
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China NMPA – Vendor and GMP Inspections.
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Singapore HSA – Investigator Site Inspections. GMP Inspections.
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Brazil ANVISA and BGMP– Investigator Site Inspections. GMP Inspections.
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Turkey TMMDA – GMP Inspections.
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Egypt EDA – GMP Inspections.
Co-Founder and Principal Consultant
Steven Van Hoozen
Steven is the owner of TrekClinical, LLC and is based out of Illinois. Steven has 20+ years of experience in Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP). Steven has worked at three (3) of the top 100 pharmaceutical companies but has also had experience at small biotech companies. Steven was the Head of QA responsible for Discovery, Pre-Clinical, Clinical, and Pharmacovigilance.
Steven has experience in the following therapeutic areas: Oncology, Vaccines, Cardiovascular, Metabolic, CNS, Pain, Dermatology, Women’s Health and Tobacco studies.
Steven is experienced in pharmaceutical, device and combination products.
TrekClinical, LLC was founded in 2019.
Steven has audit experience in the following Regions:
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United States
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Canada
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Mexico
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South America
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Europe
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Asia
Steven has regulatory authority experience with the following:
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US FDA – Sponsor and Investigator Site Inspections
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Health Canada – Sponsor and Investigator Site Inspections
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UK MHRA – Sponsor Inspections and Investigator Site Inspections
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EU EMA – Sponsor Inspections and Investigator Site Inspections
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China NMPA – Sponsor, Vendor and Investigator Site Inspections
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Philippines PFDA – Investigator Site Inspections
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Colombia CAIMED and INVIMA - Investigator Site Inspections
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Brazil ANVISA – Investigator Site Inspections
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India CDSCO – Investigator Site Inspections