Validant 合伙人

Validant 经验丰富的合伙人由行业专家、前生命科学行业的领导者以及卫生机构的前监管人员组成。他们共同提供监管、合规及质量解决方案,这些解决方案既务实又符合卫生当局的最新期望。

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Brian has over 35 years of experience providing quality, regulatory, medical safety, clinical, and strategic leadership for global healthcare businesses.

Brian Burns

President

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.

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.

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’s 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.

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.

Brian Burns Photo

Brian Burns

President

 

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Throughout his 39-year career, Bob has been a preferred advisor to senior pharmaceutical and medical device executives seeking counsel on compliance.

Robert Rhoades

Managing Partner

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.

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.

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’s 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 “Risky Business: Managing the Quality of America’s Medicines,” now in its second edition.

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Robert Rhoades

Managing Partner

 

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With over 30 years of pharmaceutical and biotechnology industry experience, Stephanie brings Quality, Regulatory, and Aseptic Manufacturing Operations expertise to her role.

Stephanie Colotti

Senior Partner

Stephanie serves as Senior Partner at Validant. With over 30 years of pharmaceutical and biotechnology industry experience, Stephanie brings Quality, Regulatory, and Aseptic Manufacturing Operations expertise to her role.

She most recently worked at Promega Corporation, the largest privately held biotechnology company in the world. There, she served as the lead cGMP technical program manager specializing in capital equipment and design control projects. She was also Promega’s internal resource for Lean/Six Sigma initiatives.  Stephanie led the fabrication and installation program for two fully cGMP compliant RABS fill/finish manufacturing lines.  One was a bottle/vial fill/finishing line, while the other was a cartridge fill/finish line.  She also led a new product introduction program for Promega’s first cGMP compliant DNA purification system.  The Maxwell® system is comprised of a software-controlled instrument, disposables, and reagents working together to provide reliable and rapid DNA purification from patient fluid or tissue samples.

Before joining Validant, Stephanie worked in new product introduction, project management, process and product validation, and quality for Baxter Healthcare for more than 20 years.  There she had leadership responsibility for two of Baxter’s Top Five projects.  One was a multi-million dollar barrier isolator installation that manufactured a lyophilized plasma-based hemophilia product.  The second was a $40 million barrier isolator pre-filled syringe platform utilizing in-line e-beam sterilization technology.  Previously, Stephanie led several critical cleanroom installations and qualifications at various Baxter sites.  She has led manufacturing expansions and Greenfield projects.  Stephanie is an expert in aseptic parenteral solution manufacturing, specifically in the areas of formulation, fill and finishing operations.

Stephanie earned a Bachelor of Science Health Care Management from Southern Illinois University and an MBA from Delta State University.

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Stephanie Colotti

Senior Partner

 

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Kurt has over 39 years of experience within the pharmaceutical, medical device and healthcare industries, including with 3 of the largest worldwide pharmaceutical companies.

Kurt Moerck, Ph.D.

Partner

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

Kurt’s 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.  Responsibilities have also included Global Senior Advisor and  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.

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.

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

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.

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Kurt Moerck, Ph.D.

Partner

 

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Janet has over 25 years of experience in medical devices, biotech, in vitro diagnostics and combination products.

Janet Whipple

Partner

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

Most recently, Jan served as the project team lead for multiple clients at Validant. While consulting, Jan’s 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).  Jan has led multiple Quality System area improvements, including CAPA, Design Control, Risk Management, Supplier Management, Documentation Control, and Post-Market Surveillance.

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.

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Janet Whipple

Partner

 

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