Submitting FDA Electronic Regulatory Filings – Drug Establishment Registrations and Drug Listings 2014
15 May 2014
Webinar
Key Topics
Transition from paper-based to electronic process
Overview of FDA drug establishment and listing requirement
Extensible Markup Language (XML)
Creation of electronic files
Codes and code sets
Structured Product Labeling (SPL)
Submission to ESG
Establishing FDA Gateway (ESG) account
Checking drug establishment registration and listing status
Who should Attend
Project Managers
Egulatory Affairs professionals
Prescription Drug manufacturers
QA & QC Managers
Active pharmaceutical ingredient (API) Drug manufacturers
Over-the-counter (OTC) Drug manufacturers
Medical Gas Drug manufacturers
Homeopathic Drug manufacturers
Any individuals interested in the drug industry
Consultants
Past Events
Submitting FDA Electronic Regulatory Filings – Drug Establishment Registrations and Drug Listings 2014 - 15 May 2014, Webinar (42542)
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