Mike and Mark Karhoff
Mike Karhoff is a supply chain and project management consultant at Ten Count Consulting, LLC. He serves as the DSCSA assessment lead and coordinates a pharma manufacturer best practices forum. Mike has over 25 years of experience in project management, manufacturing quality, and engineering roles. He has a diverse background of project management in the pharma, foundry, and automotive industries. He lives with his family in Northwest Ohio and travels to clients throughout the U.S. You can reach him at mike.karhoff@tencountconsulting.com or connect with him on LinkedIn.
Mark Karhoff is a supply chain consultant and founder of Ten Count Consulting, LLC. He has 25 years of experience in program management, process improvement, supply chain solutions, and blockchain, as well as DSCSA (Drug Supply Chain Security Act) compliance. Mark has served as a contracted pharmaceutical client representative with industry groups such as PDG (Partnership for DSCSA Governance), HDA, GS1, and PDSA to establish standards and build alignment on solutions to meet the unfolding U.S. law. He lives with his family in Chicago and believes in advancing corporate social responsibility through his volunteer work with a job skills program for 18- to 24-year-old urban youth called Year Up-Chicago. You can reach him at mark.karhoff@tencountconsulting.com or connect with him on LinkedIn.
ARTICLES BY MIKE AND MARK KARHOFF
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![Life Ring]( "6 Things We Need From FDA Before Full 2023 DSCSA Enforcement")
6 Things We Need From FDA Before Full 2023 DSCSA Enforcement1/6/2021This article suggests concrete actions the FDA can take to help unify a complex and diverse group of stakeholders prior to enforcing the full requirements of the Drug Supply Chain Security Act (DSCSA) in Nov. 2023.
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![Acupuncture Needles]( "Helping Pharma Manufacturers Overcome DSCSA Interoperability Pain Points")
Helping Pharma Manufacturers Overcome DSCSA Interoperability Pain Points4/13/2020With the FDA guidance documents and requirements of the Drug Supply Chain Security Act still unfolding, there is a growing need for sectors in the supply chain to align on how to meet various aspects of the law.
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![FDA Showing Up]( "Are You Ready For A DSCSA Audit? 5 Steps To Ensure The Answer Is “Yes”")
Are You Ready For A DSCSA Audit? 5 Steps To Ensure The Answer Is “Yes”3/16/2020During an FDA audit, you're asked questions about the U.S. Drug Supply Chain Security Act and how you offer and share your T3 data with downstream trading partners. Do you answer confidently, or hold your breath and gulp?
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![blockchain_digitization.png]( "5 Barriers To Blockchain Adoption In The Rx Supply Chain — And How To Overcome Them")
5 Barriers To Blockchain Adoption In The Rx Supply Chain — And How To Overcome Them9/11/2019Blockchain has already started to find fit-for-purpose use cases in the pharmaceutical industry. Some of the largest pharma companies in the world are now conducting pilots and are expected to move towards production cases in the coming year. But for blockchain to succeed, several remaining obstacles must still be overcome.
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![iStock_checkboxes]( "DSCSA’s 2023 Interoperability Requirements: Don’t Just Check The Compliance Box")
DSCSA’s 2023 Interoperability Requirements: Don’t Just Check The Compliance Box6/27/2019The Drug Supply Chain Security Act (DSCSA) requires creation of an interoperable system by 2023 to facilitate the sharing and gathering of transactional information back to the packaging at the original manufacturer for authorized trading partners or government agents in the event of a suspicious or illegitimate product. How will this system work and what components and governance will be required?
