Camille Davis Thornton
Founder of MACE Concepts, LLC
Camille Davis Thornton, M.S., RAC is the founder of MACE Concepts, LLC, an independent consultancy specializing in providing innovative regulatory, compliance, and training solutions. Ms. Thornton has an M.S. in Biotechnology from The Johns Hopkins University and certifications from the Regulatory Affairs Professionals Society (RAC-US) and the National Restaurant Association (ServSafe® Food Protection Manager, Instructor, and registered Examination Proctor). Additionally, she has over 15 years of experience in multiple regulated industries and actively teaches at the college level. Ms. Thornton areas of expertise include regulatory filings, the FDA Electronic Submissions Gateway (ESG), and liaising with government agencies. Also known as the "Perpetual Inquisitive Geek", she regularly reviews applicable guidance documents, notifications, newsletters, blog postings, and email alerts from various government agencies to stay up-to-date with current requirements and industry trends. Ms. Thornton is a regulatory affairs professional and trainer with a true passion for sharing knowledge effectively.
Upcoming Webinar
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Recorded Webinar
Determining a Regulatory Pathway for your Over-the-Counter (OTC) Drug Product
Over-the-counter (OTC) drug products are sold directly to consumers without the need of a prescription from a healthcare provider. In the US, these products are regulated by the Food and Drug Administration (FDA). Because of the large number of marketed OTC drug products, FDA reviews the active ingredients and labeling of over 80 therapeutic classes of drugs (e.g., analgesics) instead of individual drug products. This webinar will provide clarification on determining a regulatory pathway to bring your OTC drug product to market.
Recorded Session Get life time access for one participant with download option!

Submitting FDA Electronic Regulatory Filings – Drug Establishment Registrations and Drug Listings
US Food and Drug Administration (FDA) now requires electronic submission for labeler code requests, drug establishment registrations, drug listings, annual renewals, and updates. The electronic process replaces FDA paper forms 2656 (Registration of Drug Establishment/Labeler Code Assignment), 2657 (Drug Product Listing), and 2658 (Registered Establishments’ Report of Private Label Distributors). To transmit files, companies must use the FDA’s Electronic Submission Gateway (ESG). According to FDA, moving from a paper-based format to an electronic system has improved the timeliness and accuracy of submissions. This webinar will provide clarification on the process of submitting drug establishment registration and drug listing information to the FDA.
Recorded Session Get life time access for one participant with download option!

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