Background
Ron is a recognized expert in the regulatory arena with over 30 years of domestic and international experience with both regulated and unregulated industries. His vast experience, expertise and knowledge enable him to provide practical guidance for each client in areas such as manufacturing processes, quality systems and business performance.
Ron has led SAI Global's regulatory program (medical device, pharmaceutical, biotech) for over 16 years. He has utilized his engineering education and in depth experience in R&D, product safety, product management and regulatory affairs in the development and implementation of effective quality systems that not only comply with domestic/international regulatory requirements and standards, but enhance overall business operations and improve the bottom line.
Ron has worked with companies ranging from small, private organizations to Fortune 100 firms within industries including medical device, biotech, pharmaceutical and contract manufacturing as well as with government agencies (both US and international). He has worked with a number of companies in Europe, where he was responsible for implementing quality systems that met the requirements of ISO 9001, ISO 13485, FDA's cGMPs/QSR, and other specialized industry standards.
Specialties
Ron's strengths include strategic planning related to international and domestic regulatory requirements as well as the integration of these requirements within a company's business management system. He has been successful in helping companies to link these areas to business process improvement and ensure continued effectiveness.
Ron also is a dynamic and effective presenter who possesses the ability to effectively communicate to all levels within organization - from executive management to plant floor personnel. He is particular effective with executive management, helping them to understand the business value of quality systems and regulatory compliance along with the liabilities and concerns involved.
Ron has trained thousands in areas such as quality management systems (ISO 13485, ISO 9001), FDA cGMPs/QSR, international regulatory requirements (EU Directives, CMDCAS), internal and lead auditing, design control for medical devices, risk management / ISO 14971 for medical devices, risk analysis/FMEA for medical devices, corrective / preventive action as well as many other areas.
Clients
As a trainer and consultant with SAI Global, Ron has been instrumental in assisting numerous companies throughout their efforts to comply with international standards (ISO 9001, ISO 13485) and regulatory requirements (FDA cGMPs/QSR, CMDCAS, EU Directives).
Some clients for whom Ron has provided in-depth training and consulting support are: Siemens Medical Solutions, Boston Scientific Corp., Agilent Technologies, Stryker Corp, Guidant Corp., General Electric Medical Systems, Bayer Corporation, Beckman-Coulter, Phillips Medical, Johnson & Johnson Company (including Depuy Othropaedics, Ethicon/Ethicon Endosurgery, Vision Care and other divisions), Flextronics International, Jabil Circuits and US, European and Canadian regulatory agencies.
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