Submitting FDA Electronic Regulatory Filings Drug Establishment Registrations and Drug Listings 2014 is a webinar that covers topics such as:
- 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
Submitting FDA Electronic Regulatory Filings Drug Establishment Registrations and Drug Listings 2014 is intended for:
- 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
