SPL Specification and Authoring Training
The following SPL courses are available:
- Introduction to SPL - Understanding SPL
- Introduction to labelBridge - SPL editing
- Customized Training and Mentoring Service
Introduction to SPL - SPL filing
During this half-day course, you will learn the fundamental concepts behind submitting SPL submissions to the FDA. In this course, you will gain an understand the underlying purpose of SPL submissions, learn how to interpret the FDA's SPL specification documents and get an understanding of the terminology used. The different types and purposes for SPL documents (NDC Labeler Code Request, Establishment Registration, GDUFA Self Identification, and Drug Listing) will be covered and the analysis process through which a print-ready drug label is converted to a submission-ready SPL drug listing file will be explained.
Introduction to labelBridge - SPL editing
During this one-day course, you will learn the fundamental concepts for creating and filing SPL submissions for the FDA using labelBridge.You will learn basic operations such as accessing the application, navigating the labelBridge user interface, repository tree and online help.
You will also learn about creating projects, documents and versions. You will learn intermediate operations that include importing existing labels, editing projects, documents and version information. Additionally, you will learn advanced operations that include editing information using the Document Tree, NDC Forms, Establishment forms including Search and Replace functions. Finally, you will validate a label version, examine the validation reports, approve and publish a label version.
Customized Training and Mentoring Service