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

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:

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