Submitting FDA Electronic Regulatory Filings - Drug Establishment Registrations and Drug Listings

Why Should You Attend:

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. If you keep in mind that the FDA portal can be accessed 24 hours a day, there is the added benefit that properly created Structured Product Labeling (SPL) files can theoretically be processed in minutes.

Even with the stated benefits, the electronic submissions process can be intimidating. File creation is but one hurdle to overcome. Gaining access to the FDA electronic portal is often another. This webinar offers a click-by-click walk-through of the process with helpful tips and suggestions along the way. October - December 2016 is the FDA annual re-registration window. Having knowledge of the electronic process will best ensure your submissions are not delayed!

Learning Objectives:

• Fostering a much better understanding of the electronic submission process for drug establishment registrations and drug listings
• Having a high comfort level with establishing a CDER Direct account, creating Structured Product Labeling (SPL) files, and submitting files directly to FDA for review
• Weighing the option of alternative methods
• Checking your drug establishment registration and drug listing status with FDA

Areas Covered in the Webinar:

• Overview of FDA drug establishment and listing requirement
• Transition from paper-based to electronic process
• Establishing a CDER Direct (submission portal) account
• Creating SPL files within CDER Direct
• Submitting SPL files through CDER Direct
• Other options for SPL creation and submission
• Checking drug establishment registration and listing status with FDA

Who Will Benefit:

This webinar will provide valuable assistance to:

• Pharmaceutical Regulatory Affairs professionals
• Project Managers
• Pharmaceutical QA and QC Managers
• Drug manufacturers including prescription, over-the-counter (OTC), active pharmaceutical ingredient (API), homeopathic, and medical gas
• Consultants
• Any individuals interested in the drug industry

Camille Davis Thornton
Founder, 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.

Topic Background:

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.

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