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Dave Schoneker
President/Owner/Regulatory & Quality Consultant - Black Diamond Regulatory Consulting, LLC
Professional Background
Dave Schoneker is a seasoned professional with over 42 years of rich experience in regulatory affairs and quality assurance specifically within the pharmaceutical excipients, non-dietary ingredients for dietary supplements, food additives, and color additives sectors. His extensive career is marked by a commitment to enhancing industry standards, compliance, and product quality through his leadership in various esteemed organizations. As the President, Owner, and Consultant at Black Diamond Regulatory Consulting, LLC, Dave uses his vast expertise to assist companies grappling with complex regulatory, quality issues, auditing demands, or training requirements. His unique insights into solid oral dosage forms have made him a sought-after consultant for organizations looking to navigate the challenging landscape of regulatory compliance in today's fast-evolving market.
Throughout his career, Dave has actively participated in numerous formulation and problem-solving projects. His ability to address and solve intricate problems in formulation and compliance has garnered a reputation that precedes him in the industry. His involvement with significant trade associations has bolstered his role as an influential figure in shaping regulations and guidance surrounding excipients, food additives, and colorants worldwide. With a focus on collaborative leadership and knowledge sharing, he continues to contribute to the betterment of industry practices and understanding of scientific advancements.
Education and Achievements
Dave's academic background lays a strong foundation for his successful career in chemistry and regulatory affairs. He earned a Bachelor of Science degree in Chemistry from Ursinus College, which provided him with essential scientific knowledge and analytical skills. He further honed his expertise by obtaining a Master's degree in Analytical Chemistry from Villanova University. This rigorous education empowered him to tackle complex scientific issues and develop strategies for regulatory compliance across various sectors of the industry.
In addition to his formal education, Dave's professional achievements speak volumes about his dedication and influence in the field. He has served in numerous high-profile leadership roles with impactful organizations. As an Adjunct Professor in the Graduate RA/QA Program at Temple University School of Pharmacy, he passionately shares his extensive knowledge with aspiring professionals, nurturing the next generation of leaders in the regulatory affairs and quality assurance space.
His history of leadership includes pivotal roles such as the Vice Chair for Science and Regulatory Policy at IPEC-Americas, where he played a vital role in advocating for science-based regulations. His contributions extend as a Board Member at the IPEC Foundation and as the President of the International Association of Color Manufacturers Inc. (IACM), where he worked tirelessly to enhance color additive regulations and industry practices.
Dave’s commitment to quality and regulatory excellence is also evident from his previous tenure at Colorcon, where he served as the Global Regulatory Director for Strategic Relationships, successfully managing and influencing regulatory strategies globally. His role as a Former Convention Delegate at the United States Pharmacopeia reflects his deep involvement in establishing and influencing standards that safeguard public health.
Achievements
Dave Schoneker's notable achievements reflect his unwavering dedication to the fields of regulatory affairs and quality assurance. He has been instrumental in shaping critical regulations and guidance that impact the excipient, food additive, and colorant industries. His work with key organizations has led to meaningful changes that improve product safety, efficacy, and quality worldwide.
Calibrating his expertise towards solving regulatory challenges, Dave has fostered collaborative efforts that unite industry peers to address pressing issues. His leadership roles in various organizations not only reflect his personal accomplishments but also showcase his commitment to serving the community and driving improvements within the industry. His remarkable ability to clearly communicate complex regulatory concepts has empowered his peers and clients alike, establishing him as a leading voice in the sector.
As a result of his extensive experience and accolades, Dave has built a vast network of professional relationships throughout the regulatory landscape, enabling him to provide tailored insights and support to his clients. His approach combines scientific understanding with strategic thinking, ensuring that businesses receive expert guidance as they navigate through regulatory complexities.
In summary, Dave Schoneker embodies the essence of dedication and expertise in the regulatory affairs and quality sectors. His long-standing career, enriched with achievements and contributions to critical organizations, cements his reputation as a trusted consultant and leader. Through his work at Black Diamond Regulatory Consulting, LLC, he continues to make a positive impact on the industry, contributing to the safety and quality of products consumed by the public every day.
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