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PLR Recent Major Changes
New Materials and Updates
Wikispaces : SPL-work-group - all changes
Feb 7, 2017
20170111 SPL ERDL minutes - final rule_MEI- w FDA responses.pdf
Feb 7, 2017
SPL eBooks - Graphic Guides
eBooks for SPL
Update: April 30, 2012:
The FDA is doing a complete revision and overhaul of the eBooks and eCards. The new eBooks and eCards are posted on this web page:
In the future, new or revised validation procedures/solutions will be marked with an asterisk in updated versions of these eBooks. Since these are the first (the other error solution eBook was a combined version with information about all SPL types) versions, it would be confusing to some readers if asterisks were included.
The first two SPL training eBooks for error messages/solutions are now on the site: one for NDC/NHRIC labeler code and one for establishment registration SPL files.
SPL Xforms Training eBooks
SPL Training eBook # 1 - Basic Instructions for Using the SPL Xforms (PDF)
SPL Training eBook # 2 - Creating NDC Labeler Code & Establishment Registration SPL Files Using SPL Xforms (PDF)
SPL Training eBook # 3 - Creating Medicated Animal Feed Mill Establishment Registration SPL Files Using SPL Xforms (PDF)
SPL Training eBook # 4 - Locating the Core ID and Downloading Error Messages (PDF)
SPL Training eBook # 5 - Configuring Your Computer to Read System-Generated Error Messages (PDF)
SPL Training eBook # 6 - NDC/NHRIC Labeler Code SPL Technical Errors/Solutions (PDF)
SPL Training eBook # 7 - Establishment Registration SPL Technical Errors/Solutions (PDF)
SPL Training eBook # 8 - Content of Labeling/Product Data Elements SPL Technical Errors/Solutions (PDF)
SPL Training eBook # 9 - Submitting SPL Files via the FDA OC Gateway Portal (PDF)
These are a series of training "eBooks" designed to assist companies to submit valid and compliant SPL R4 documents via the FDA's Electronic Submission Gateway.
These training eBooks are considered as SPL R4 technical training tools and will be distributed to registrants of FDA SPL R4 training sessions as well as any person requesting technical assistance related to SPL R4.
SPL eCards [Quick References
SPL training notes
SPL Pathways Training
eBook 1: "Adding Images to SPL Documents Using SPL Xforms,"
eBook 2: "Sending SPL R4 documents submitted to FDA for the purpose of registering a drug establishment or listing a drug product".
eBook 3: "Creating NDC Labeler Code SPL Documents"
eBook 4: "Creating Establishment Registration SPL Documents"
eBook 5: "Creating Listings for Compressed Medical Gas Drug Products"
eBook 6: "Creating Bulk Ingredient Listing SPL Documents"
eBook 7: "Creating Listing SPL Documents for Products Which are Both Cosmetics and Drugs"
[Revision one for this eBook issued 27-Oct-2009. The purpose of this revision is to provide clarification regarding the product type.]
eBook 8: "Creating Homeopathic Drug Listing SPL Documents"
eBook 9: "Using SPL R4 Xforms to Save or Reopen SPL Documents"
eBook 10: "Locating Gateway Core IDs & Downloading SPL R4 Error Messages"
eBook 11: "
Installing Mozzie add-on;
Downloading and Opening SPL R4 Xforms"
eBook 12: "Creating OTC Drug Listing SPL Documents"
eBook 13: "Creating Human Rx Drug Listing SPL Documents"
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