August 18, 2020
In this episode, Stacey is joined by Valarie King-Bailey, John E Lincoln, and Dr. Siegfried Schmitt for a panel discussion on Life Science Industry Challenges, Opportunities, and Next Steps.
Valarie King-Bailey – Valarie is the CEO of OnShore Technology Group, an independent Chicago-based consultancy specializing in Independent Validation and Verification (IV&V) products and solutions. OnShore’s product, ValidationMaster™ is the first fully integrated Enterprise Validation Management system on the market. ValidationMaster™ was recognized by CIO Review Magazine as one of the top 20 most promising technologies for life sciences in 2015. OnShore led the development of the first FDA Validation Toolkit for Microsoft Dynamics AX and Microsoft NAV. Valarie has worked for leading global companies such as QUMAS Limited (Ireland), EMC/Documentum, Abbott Laboratories, and U.S. Steel – South Works. At QUMAS, an Irish-based software company, she served as Chief Marketing Officer where she was responsible for all global tactical and strategic marketing initiatives in addition to the development of their validation toolkit. Valarie founded OnShore Technology Group in 2004. OnShore Technology Group recently won the American Express/Count Me In M3 Award and the Madam C.J. Walker Outstanding Business Award (2008). She also received a nomination for Ernst & Young Entrepreneur of the Year award in 2006. Ms. King- Bailey holds an M.B.A. in Information Systems from Keller Graduate School of Management (1985) and a B.S. in Civil and Environmental Engineering from the University of Wisconsin – Madison (1982).
John E. Lincoln – John is principal consultant, J. E. Lincoln and Associates LLC, assists companies in the design and implementation of complete 21 CFR 111, 210, 211, 820 and ISO 13485 quality management systems, fully CGMP- compliant, and which have passed FDA audits. He compiles 510(k) submissions, new and changed, product Risk Management Files / Reports per ISO 14971, Design History Files, Technical Files, and Design Dossiers. He assists companies in remediation / FDA responses, SOP writing, audits, validations, including software. His work is described in peer-reviewed technical articles and workshops, worldwide. John has also managed pilot production, regulatory affairs, product development / design control projects. He has over 35 years of experience, 21 as a full time consultant, primarily with medical devices – working with start-ups to Fortune 100 companies. He is a graduate of UCLA.
Dr. Siegfried Schmitt - Siegfried is Vice President, Regulatory and Access, at PAREXEL Consulting, where he has worked at developing and improving quality management systems; including Quality by Design and Control Strategies since 2007. He is a Thought Leader in Competitive Compliance, Data Integrity and Supply Chain, a trusted expert for regulatory, compliance and industry-best-practices projects. Siegfried has more than 30 years’ experience in the healthcare industry, spanning manufacture, analytics, validation and quality assurance. Siegfried received his Ph.D. in Organic Chemistry from the University of Berne, Switzerland and is a Fellow of the Royal Society of Chemistry. Dr. Schmitt is an active member of various industry associations, including DIA, PDA and ISPE, conference presenter and organizer of international events. He is also an accomplished author and editor, having won the coveted ‘distinguished PDA author / editor award’ in 2008 and 2012. Dr Schmitt is a Chemist by background and holds Chartered Chemist and Chartered Scientist status.
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