Management of FDA CFSAN (Center for Food Safety and Applied Nutrition) and CDER (Center for Drug Evaluation and Research) compliance activities including labeling, complaint/adverse event investigation programs and customer inquiry. Includes review and approval company’s product labeling and promotional information used in print, speaker educational programs, video, websites, or in social media. Manage contacts and submissions with FDA regarding label revisions and product promotional information as required by the Division of Drug Marketing, Advertising, and Communications. Work with Business Development on new product packaging, labeling and promotional material particularly compliance for medical foods. Responsibilities include all state aggregate spend reporting requirements and federal rules to the Physician Payment Sunshine Provisions of the Patient Protection Affordable Care Act. In the past year, focus has been on managing and assembling the team needed to find the appropriate solution for Pamlab to the federal requirements. This also involved developing training modules for all affected departments. Other departmental compliance activities include PhRMA code, PDMA, post marketed surveillance of drug products, response to FDA Medwatch adverse event notifications and the new Reportable Food Registry. Responsible for the adverse event investigation program, complaints investigation.Approve and develop responses to technical questions or product message submitted from sales, national accounts, the medical community or consumers. Other duties involve design and development of Pamlab quality programs and management of corporate SOPs. Corporate assignments include being the Quality/Regulatory representative on the new product development team and the website oversight committee.

Corporate Manager working internationally providing auditing, testing, specialized certifications, and other supply chain related services for clients in the food, pharmaceutical or cosmetic industries. Program management includes site evaluations using Food Safety/HACCP audits, Pharmaceutical, Cosmetic and Medical Device cGMP and Quality System assessments, sampling and product testing programs, development of product specifications, and label and packaging verifications for FDA/USDA regulatory compliance. Certified to implement and conduct SQF (Safe Quality Food) certifications that support HACCP based systems in several specific food industry sectors. ISO 9001-2000 lead auditor certified. Certified by the International HACCP Alliance. Program manager working for IPEC-Americas (International Pharmaceutical Excipient Council) global IPEA pharmaceutical excipient audits.International travel involved training and evaluation of global inspection team and customer requests for assistance with specialized quality related program development and investigations.