I provide strategic counseling to industry regarding regulatory compliance requirements for food packaging materials and food ingredients across the globe.As an Industrial Engineer with experience in manufacturing, I recognize the importance of providing clients with timely and actionable advice regarding critical regulatory decisions that drive product innovation, marketing, and promotion. I leverage this experience to assist companies in proactively establishing compliance for… Show more I provide strategic counseling to industry regarding regulatory compliance requirements for food packaging materials and food ingredients across the globe.As an Industrial Engineer with experience in manufacturing, I recognize the importance of providing clients with timely and actionable advice regarding critical regulatory decisions that drive product innovation, marketing, and promotion. I leverage this experience to assist companies in proactively establishing compliance for products under the laws and regulations administered by the US Food and Drug Administration (FDA). I am familiar with food contact material regimes in the European Union (EU) and jurisdictions throughout Asia and South America.I regularly speak to professional organizations and trade associations about developing, implementing, and promoting Good Manufacturing Practice (GMP) strategies and Standard Operating Procedures (SOPs) for regulated facilities, and has authored a number of publications on this topic. I use my technical background and internal auditing experience to assist clients to prevent and – when necessary – respond to product contamination and recall situations. Show less

I assisted companies, organizations and trade associations in establishing compliance with regulatory requirements for food packaging materials and food ingredients throughout the United States, European Union (EU), Asia and South America. Specifically, I assisted clients in establishing a suitable U.S. Food and Drug Administration (FDA) status, and exemption from premarket review, for a variety of food-contact materials, and I successfully filed numerous Food Contact Notifications (FCNs) with… Show more I assisted companies, organizations and trade associations in establishing compliance with regulatory requirements for food packaging materials and food ingredients throughout the United States, European Union (EU), Asia and South America. Specifically, I assisted clients in establishing a suitable U.S. Food and Drug Administration (FDA) status, and exemption from premarket review, for a variety of food-contact materials, and I successfully filed numerous Food Contact Notifications (FCNs) with FDA for new and innovative polymers, additives, and processing aids used in the manufacture of food-contact articles. In addition, I advised clients regarding the suitable status of food-contact materials under the EU Framework Regulation, and the Plastics Regulation (EU) No. 10/2011.I was also a principal member of Keller and Heckman’s Tobacco and E-Vapor Audit and Inspection Program (AIP), which is designed to provide companies that are involved in any aspect of the tobacco or vapor product supply chain with confidence that their facilities are operating in accordance with FDA requirements. I conducted on-site training and auditing to evaluate and recommend improvements to e-liquid manufacturers and retailers under the Tobacco Control Act. Show less

Operations Engineer/Supply Chain Analyst (2006-2007)Reviewed logistics practices and recommended/developed efficient, cost-effective solutions for finished medical device product distributionIndustrial Engineer - Cooperative Education Program (2004-2006)Implemented process improvements throughout various aspects of the company's manufacturing and distribution systems, including enhancements to raw material inventory control systems, production line balancing and quality… Show more Operations Engineer/Supply Chain Analyst (2006-2007)Reviewed logistics practices and recommended/developed efficient, cost-effective solutions for finished medical device product distributionIndustrial Engineer - Cooperative Education Program (2004-2006)Implemented process improvements throughout various aspects of the company's manufacturing and distribution systems, including enhancements to raw material inventory control systems, production line balancing and quality inspection programs. Developed operations metrics monitoring and reporting programs. Show less