Camille Davis Thornton
Camille Davis Thornton
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’s 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.
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Drug Master Files: New Implications under GDUFA
The Generic Drug User Fee Amendments of 2012 (GDUFA) were designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry. A Drug Master File (DMF) is a submission to the... -
Drug Master Files: New Implications under GDUFA
The Generic Drug User Fee Amendments of 2012 (GDUFA) were designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry. A Drug Master File (DMF) is a submission to the... -
Drug Master Files: New Implications under GDUFA
Description: The Generic Drug User Fee Amendments of 2012 (GDUFA) were designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry. A Drug Master File (DMF) is a submission to... -
FDA Electronic Regulatory Filings Submission – Drug Establishment Registrations and Drug Listings
Description: This webinar will provide clarification and guidance on the process of submitting drug establishment registration and drug listing information to the FDA. US Food and Drug Administration (FDA) now requires electronic submission for labeler code requests, drug establishment... -
Best Practices in choosing a Regulatory Pathway for your Over-the-Counter (OTC) Drug Product
Description: 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... -
FDA Electronic Regulatory Filings Submission – Drug Establishment Registrations and Drug Listings
Description: FDA gives a number of reasons for the decision to move away from paper submissions. These include: electronic review of drug labels for compliance, elimination of data entry errors, and creation of a more efficient and effective process.... -
Drug Master Files: New Implications under GDUFA
Description: The Generic Drug User Fee Amendments of 2012 (GDUFA) were designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry. A Drug Master File (DMF) is a submission to... -
Drug Master Files: New Implications under GDUFA
Description: The Generic Drug User Fee Amendments of 2012 (GDUFA) were designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry. A Drug Master File (DMF) is a submission to... -
Sale!
FDA Electronic Regulatory Filings Submission – Drug Establishment Registrations and Drug Listings
Description: This webinar will provide clarification and guidance on the process of submitting drug establishment registration and drug listing information to the FDA. US Food and Drug Administration (FDA) now requires electronic submission for labeler code requests, drug establishment... -
Sale!
Best Practices in choosing a Regulatory Pathway for your Over-the-Counter (OTC) Drug Product
Description: 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... -
FDA Electronic Regulatory Filings Submission – Drug Establishment Registrations and Drug Listings
Description: FDA gives a number of reasons for the decision to move away from paper submissions. These include: electronic review of drug labels for compliance, elimination of data entry errors, and creation of a more efficient and effective process.... -
Drug Master Files: New Implications under GDUFA
Description: The Generic Drug User Fee Amendments of 2012 (GDUFA) were designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry. A Drug Master File (DMF) is a submission to...