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

Event Details

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

Time: February 20, 2014 from 10am to 11am
Location: Online Event
Street: 2600 E. Bayshore Road
City/Town: Palo Alto
Website or Map: http://www.complianceonline.c…
Phone: +1-650-620-3915
Event Type: pharmaceutical
Organized By: ComplianceOnline
Latest Activity: Feb 6, 2014

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Event Description

This webinar on FDA electronic filings will discuss and provide clarification on the process of submitting drug establishment registration and drug listing information to the FDA using its Electronic Submission Gateway (ESG).

Why Should You Attend:

To facilitate the submission of drug establishment registration and drug listing information (including labeling), FDA adopted the use of Extensible Markup Language (XML) files in the Structured Product Labeling (SPL) format. The necessary submissions to remain compliant include an Establishment Registration SPL, an NDC Labeler Code Request SPL and a Drug Listing SPL. Once the SPL file is created, it can then be submitted (uploaded) to the ESG. This includes digital certification since the submission is a secure one.

This webinar will allow participants to gain a better understanding of the electronic submission process for drug establishment registrations and drug listings. During the session, we will discuss key concepts including XML, SPL, and ESG. The training has been designed to be a step-by-step guide in helping you transition to the electronic process.

Areas Covered in the Webinar:

  • Overview of FDA drug establishment and listing requirement
  • Transition from paper-based to electronic process
  • Creation of electronic files
    • Extensible Markup Language (XML)
    • Structured Product Labeling (SPL)
    • Codes and code sets
  • Establishing FDA Gateway (ESG) account
  • Submission to ESG
  • Checking drug establishment registration and listing status

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

Instructor Profile:

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.

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