{"id":1675,"date":"2021-03-12T17:42:42","date_gmt":"2021-03-12T17:42:42","guid":{"rendered":"http:\/\/www.validant.com\/unsere-partner\/"},"modified":"2021-04-14T19:15:49","modified_gmt":"2021-04-14T19:15:49","slug":"unsere-partner","status":"publish","type":"page","link":"https:\/\/www.validant.com\/de\/unsere-partner\/","title":{"rendered":"Unsere Partner"},"content":{"rendered":"\n
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Validant Partner<\/strong><\/h1>\n<\/div>\n\n\n\n
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Zu den erfahrenen Partnern von Validant geh\u00f6ren Fachexperten, einstige F\u00fchrungskr\u00e4fte aus der Life-Sciences-Industrie sowie ehemalige Vertreter von Gesundheitsbeh\u00f6rden. Gemeinsam bieten sie bieten L\u00f6sungen in Sachen Regulierung, Compliance und Qualit\u00e4t, die sowohl pragmatisch als auch mit den aktuellen Anforderungen der Gesundheitsbeh\u00f6rden konform sind.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n\n

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\"Brian<\/p>\n\t\t\t\t\t

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\n\t\t\t\t\t\t\tBrian has over 35 years of experience providing quality, regulatory, medical safety, clinical, and strategic leadership for global healthcare businesses.\t\t\t\t\t\t<\/blockquote>\t\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
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Brian Burns<\/h3>\n\t\t\t\t\t

President<\/h4>\n\t\t\t\t\t\n
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Brian Burns is President and a Quality leader at Validant, based in the New England region. Brian brings deep executive experience in Quality and Regulatory strategy and improvement with a track record of comprehensive quality performance improvement.<\/p>\n\n\n\n

Prior to joining Validant, he served as an Executive Vice President of Global Quality and Regulatory Affairs at Haemonetics Corporation and Fresenius Medical Care over the course of five years.  Brian led institutionalizing corporate quality systems for all operational areas and upgraded quality systems to support evolving business needs such as combination products while improving complaint handling, operational metrics, supplier quality, clinical quality, and global quality systems training.<\/p>\n\n\n\n

Brian served as Executive Vice President of Global Quality, Medical Safety & Regulatory Affairs of Boston Scientific Corporation for seven years.  Brian was responsible for quality assurance for Boston Scientific\u2019s businesses worldwide and served as company liaison to all compliance bodies, including the U.S. Food and Drug Administration, European Union Competent Authorities, and the Ministry of Health, Labour and Welfare, Japan.<\/p>\n\n\n\n

Previously, Brian held various Quality Assurance, Operational, and General Manager roles with Cardinal Healthcare, Allegiance Healthcare, and Baxter Healthcare. He received his Bachelor of Science degree in Chemical Engineering with a Minor in Mathematics and Chemistry from the University of Arkansas.<\/p>\n<\/div><\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n

\"Brian<\/div>\n

Brian Burns<\/strong><\/p>\n

President<\/p>\n\t\t\t\t\t <\/a>\n\t\t \n\t\t\n <\/div>\n

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\"Bob<\/p>\n\t\t\t\t\t

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\n\t\t\t\t\t\t\tThroughout his 39-year career, Bob has been a preferred advisor to senior pharmaceutical and medical device executives seeking counsel on compliance.\t\t\t\t\t\t<\/blockquote>\t\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
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Robert Rhoades<\/h3>\n\t\t\t\t\t

Managing Partner<\/h4>\n\t\t\t\t\t\n
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Managing Partner Robert (Bob) Rhoades focuses on helping companies navigate the regulatory landscape while keeping pace with their corporate direction and strategy. He is based in Atlanta.<\/p>\n\n\n\n

A skilled practitioner of both Quality System Regulation and pharmaceutical cGMPs for nearly four decades, Bob has designed and implemented compliance improvement initiatives for major manufacturers around the world. Known for his talent in guiding clients through crisis events, his history of post-enforcement action guidance speaks for itself as a strong record of re-establishing credibility with the FDA.<\/p>\n\n\n\n

Bob previously led the Quality and Compliance consulting practice for Quintiles and served in consulting leadership roles at Becker & Associates and Impact Management Services. He\u2019s also served in key executive positions at Solvay Pharmaceuticals, Bausch & Lomb, and Baxter Healthcare. He holds a Bachelor of Science Degree in Microbiology from Purdue University and a Masters of Business Administration in Operations and Strategy from Lake Forest Graduate School of Management. He serves on the board of the Food and Drug Law Institute and authored the book \u201cRisky Business: Managing the Quality of America\u2019s Medicines,\u201d now in its second edition.<\/p>\n<\/div><\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n

\"Bob<\/div>\n

Robert Rhoades<\/strong><\/p>\n

Managing Partner<\/p>\n\t\t\t\t\t <\/a>\n\t\t \n\t\t\n <\/div>\n

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\"Kurt<\/p>\n\t\t\t\t\t

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\n\t\t\t\t\t\t\tKurt has over 39 years of experience within the pharmaceutical, medical device and healthcare industries, including with 3 of the largest worldwide pharmaceutical companies.\t\t\t\t\t\t<\/blockquote>\t\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
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Kurt Moerck, Ph.D.<\/h3>\n\t\t\t\t\t

Partner<\/h4>\n\t\t\t\t\t\n
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Kurt E. Moerck, Ph.D. is a GMP Quality and Compliance professional with over 39 years\u00b4 experience within the Pharmaceutical, Medical Device, and Healthcare Industry, including over 30 years\u2019 global experience at 3 of the largest worldwide pharmaceutical companies:\u00a0 SmithKline Beecham, Sanofi-Aventis, and Sandoz\/Novartis, as well as\u00a0 Alcon Labs. Kurt is a Partner with Validant, based in the EMEA region.<\/p>\n\n\n\n

Kurt\u2019s leadership responsibilities have included establishing and directing effective Audit and Compliance programs at SmithKline Beecham, Sanofi-Aventis, and Sandoz\/Novartis. These responsibilities involved all sites in the USA, Europe, LATAM & Asia. Kurt also has extensive experience in the Quality and Compliance aspects of R&D operations, including Clinical Trials materials, having been responsible for R&D Quality at Rhone Poulenc Rorer\/Aventis.\u00a0 Responsibilities have also included Global Senior Advisor and\u00a0 Consultant for Quality & Compliance for Sandoz\/Novartis, Sanofi-Aventis, and SmithKline Beecham. Having been involved in almost 100 inspections over the last 7 years, Kurt gained a positive reputation with the Food and Drug Agency.<\/p>\n\n\n\n

Kurt has vast experience in most dosage forms, including all forms of Drug Product, Drug Substance, Biologicals\/Biotech, Vaccines, Medical Devices, Combination Products, OTC Products, Fractionated Plasma Products, and Radiopharmaceuticals from both the quality and manufacturing perspective.<\/p>\n\n\n\n

As Associate V.P. Global Audit and Compliance, Sanofi-Aventis and Executive Director QA, directed the Quality aspects of two Consent Decrees, allowing for the lifting of shipping and production restrictions. Kurt has also been actively involved with resolving multiple Warning Letter issues<\/p>\n\n\n\n

Kurt earned a B.S. from Florida Southern College and his M.S. and Ph.D. Degrees from North Carolina State University. In addition, Kurt is fluent in English and German, both spoken and written.<\/p>\n<\/div><\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n

\"Kurt<\/div>\n

Kurt Moerck, Ph.D.<\/strong><\/p>\n

Partner<\/p>\n\t\t\t\t\t <\/a>\n\t\t \n\t\t\n <\/div>\n

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\"Janet<\/p>\n\t\t\t\t\t

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\n\t\t\t\t\t\t\tJanet has over 25 years of experience in medical devices, biotech, in vitro diagnostics and combination products.\t\t\t\t\t\t<\/blockquote>\t\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
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Janet Whipple<\/h3>\n\t\t\t\t\t

Partner<\/h4>\n\t\t\t\t\t\n
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With over\u00a0 25 years of experience,\u00a0 Jan has a\u00a0 comprehensive background in Quality, Regulatory Compliance, Design, Operations, and Project\u00a0 Management in Medical Devices, In Vitro Diagnostics,\u00a0and Combination Products with some of the largest and most respected companies, as well as small\/mid-sized start-ups.<\/p>\n\n\n\n

Most recently, Jan served as the project team lead for multiple clients at Validant. While consulting, Jan\u2019s responsibilities included leading Quality Management System integrations for multiple product\/company acquisitions and divestitures, tech transfers and plant closures, preparation for Notified Body audits and agency inspections and leading backroom activities during audits\/inspections, quality system harmonization and remediation, Risk Management remediation, project management for New Product Introductions, rebranding & labeling associated with changes in the EU Authorized Rep and Notified Bodies, implementation of ISO 14971:2012, ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP), as well as planning for the European Union Medical Device Regulation (EU MDR).\u00a0 Jan has led multiple Quality System area improvements, including CAPA, Design Control, Risk Management, Supplier Management, Documentation Control, and Post-Market Surveillance.<\/p>\n\n\n\n

Previously, Jan held various roles within Beckman Coulter including Q.A., Q.C., Quality Systems and Compliance, Manufacturing Engineering, Corporate Auditing, Packaging & Cold Chain Process Development, Supplier Management, OEM\/CMO Process Development, Logistics (Warehousing & Transportation) Quality Systems, and Validation Process Development, Due Diligence Team, Process Integration Team Lead, Compliance Remediation Team, Value Engineering, and Management Representative. Jan received her Bachelor of Science degree in Mechanical Engineering from California State Polytechnic University, Pomona, and her Masters of Business Administration from the California State University, Fullerton. She is a Licensed Mechanical Engineer in the state of California, a Six Sigma Black Belt, an RABSQA Lead Auditor, has an ASQ Certification in Quality Engineering, and a Kempner-Trego certificate in Project Management.<\/p>\n<\/div><\/div>\n\n\n\n

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\"Janet<\/div>\n

Janet Whipple<\/strong><\/p>\n

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Joe Jimenez<\/h3>\n\t\t\t\t\t

Partner<\/h4>\n\t\t\t\t\t\n

Joseph Jimenez is a global quality leader with a career spanning nearly 30-years in the pharmaceutical, medical device, human tissue, and consumer goods organizations. <\/p>\n\n\n\n

Joseph brings an exceptional record of leading change in dynamic, pharmaceutical, medical device, human tissue and consumer goods organizations, across major regulatory markets, through the practical application of strong leadership skills, broad experience, technical knowledge, and a creative approach to challenges. Consistently recognized for building high-performance teams, developing talent, and astute cultural awareness, he has established an exemplary track record of guiding pragmatic change to organizational compliance culture to bring the best out of players.<\/p>\n\n\n\n

Joseph\u2019s extensive experience includes leadership roles at Teva Pharmaceuticals where he served as Vice President, PGT Quality.  In this role, Joseph provided leadership and strategic guidance to the $1.6 billion global joint venture between Proctor & Gamble and Teva. During his 10-year tenure at Teva Pharmaceuticals, Joseph was responsible for improving compliance profiles of manufacturing facilities and leading remediation of critical and major compliance observations to improve the company\u2019s regulatory profile.<\/p>\n\n\n\n

Prior to joining Teva Pharmaceuticals, Joseph\u2019s experience included more than seven years with IVAX Pharmaceuticals in roles overseeing quality control and analytical services activities.  Most recently, Joseph established the Arches Consulting firm where he worked with foreign and domestic clients in the pharmaceutical industry to develop quality assurance and regulatory strategies for compliance with regulations.<\/p>\n\n\n\n

At the Validant Group, Joseph provides strategic guidance and support to pharmaceutical and medical device companies in areas, including: strengthening corporate quality systems; developing compliance strategies; assisting industry clients in developing and communicating corrective action plans that meet FDA expectations and that achieve and sustain compliance; conducting audits and mock inspections; ensuring inspection readiness; and providing training, coaching, and mentoring. <\/p>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n

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Joe Jimenez<\/strong><\/p>\n

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Dem Validant-Team beitreten<\/strong><\/h3>\n\t\t\t\t

Dem Validant-Team beitreten<\/a><\/p>\t\t\t\t\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n\n\n\n\n\n

<\/p>\n<\/div>\n<\/section>\n\n

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Aus: The Vantage Point<\/span><\/strong><\/h2>\n\n\n\t\n\n\n\n
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Bleiben Sie auf dem Laufenden<\/strong><\/h3>\n\n\n\n

Melden Sie sich an, um die neuesten Einblicke von unseren Partnern zu erhalten.<\/p>\n\n\n\n

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