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U.S. Department of Health and Human Services

For Industry

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SPL Standard Training

A series of Structured Product Labeling (SPL) training opportunities are being offered to individuals responsible for the preparation and submission of information to be provided in SPL format to FDA.

Background

FDA has adopted the use of extensible markup language (XML) files in a standard SPL format as the standard format for the exchange of product and facility information. The focus of the SPL training audio and web conferences will be the preparation of the SPL documents. 

  

SPL Training Sessions (live web and audio) 

Registration Information

There is no registration fee for the training sessions but pre-registration is required because of limited connections for the webinars. To register, please submit the following information via e-mail to spl@fda.hhs.gov:

  1. Attendee’s first and last name
  2. Name of your organization
  3. Session name and date of training session(s) for which you are registering.

You will be limited to one phone/web conference line per company. 

For further information, contact: spl@fda.hhs.gov.

2014 SPL Training Sessions

Session 113 - January 6, 2014 - Medicated Animal Feed Mill Establishment Registration SPL (1:00 - 2:00 p.m., ET)
Session 114 - January13, 2014 - Medicated Animal Feed Mill Establishment Registration SPL (1:00 - 2:00 p.m., ET)
Session 115 - July 28, 2014 - SPL Document Authoring Commercial Software Vendors (3:00 - 4:30 p.m., ET)
Session 116 - September 8, 2014 - SPL Document Authoring Commercial Software Vendors (3:00 - 4:30 p.m., ET)
Session 117 - September 22, 2014 - Medicated Animal Feed Mill Establishment Registration SPL (1:00 - 2:00 p.m., ET)
Session 118 - October 6, 2014 - SPL Document Authoring Commercial Software Vendors (3:30 - 4:30 p.m., ET)
Session 119 - October 27, 2014 - Medicated Animal Feed Mill Establishment Registration SPL (11:00 - 12:30 p.m., ET)
Session 120 - October 27, 2014 - SPL Document Authoring Commercial Software Vendors (3:00 - 4:00 p.m., ET)
Session 121 - November 10, 2014 - SPL Document Authoring Commercial Software Vendors (3:00 - 4:00 p.m., ET)
Session 122 - November 17, 2014 - Medicated Animal Feed Mill Establishment Registration SPL (11:30 a.m. - 1:00 p.m., ET)
Session 123 - November 17, 2014 - SPL Document Authoring Commercial Software Vendors (3:30 - 4:30 p.m., ET)
Session 124 - December 8, 2014 - Medicated Animal Feed Mill Establishment Registration SPL (11:00 - 12:30 p.m., ET)
Session 125 - December 8, 2014 - SPL Document Authoring Commercial Software Vendors (3:00 - 4:00 p.m., ET)
Session 126 - December 15, 2014 - SPL Document Authoring Commercial Software & Conversion Vendors (3:30 - 5:00 p.m., ET  

2013 SPL Training Sessions 

The 2013 SPL training sessions are scheduled Mondays from 11:30 a.m. - 12:30 p.m., ET on the following dates:

Session 101 - February 11, 2013 – New SPL Xforms 
Session 102 - February 25, 2013 – NDC Labeler Code/Establishment Registration SPL (REGISTRATION FULL)
Session 103 - March 11, 2013 – Content of Labeling/Product Data Elements SPL Part One:  Content of Labeling Sections – Human and Animal Rx & OTC Drugs (including homeopathic, medical gas, and repacked and relabeled drug products) (REGISTRATION FULL)
Session 104 - March 25, 2013 – Content of Labeling/Product Data Elements SPL Part Two:  Product Data Elements – Human and Animal Rx & OTC Drugs (including homeopathic, medical gas, and repacked and relabeled drug products (REGISTRATION FULL)
Session 105 - May 6, 2013 - New SPL Xforms 
Session 106 - June 3, 2013 - New SPL Xforms
Session 107 - October 7, 2013 - New SPL Xforms
Session 108 - November 4, 2013 - NDC Labeler Code/Establishment Registration SPL
Session 109 - November 18, 2013 - Content of Labeling/Product Data Elements SPL Part One:  Content of Labeling Sections – Human and Animal Rx & OTC Drugs (including homeopathic, medical gas, and repacked and relabeled drug products)
Session 110 - December 2, 2013 - Content of Labeling/Product Data Elements SPL Part Two:  Product Data Elements – Human and Animal Rx & OTC Drugs (including homeopathic, medical gas, and repacked and relabeled drug products)

Medicated Animal Feed Mill Establishment Registration SPL Training Sessions

The 2013 SPL training sessions are scheduled from 1:00 p.m. - 2:00 p.m., ET on the following dates:

Session 111 - December 9, 2013 - Medicated Animal Feed Mill Establishment Registration SPL
Session 112 - December 13, 2013 - Medicated Animal Feed Mill Establishment Registration SPL  
 

Past SPL Training Sessions

2012 SPL Training Sessions 

The 2012 SPL training sessions are scheduled Mondays from 11:30 a.m. - 12:30 p.m., ET on the following dates:

Session 83 - February 13, 2012 – New SPL Xforms (This class is full.)
Session 84 - February 27, 2012 – NDC Labeler Code/Establishment Registration SPL (This class is full.)
Session 85 - March 12, 2012 – Content of Labeling/Listing – Human and Animal Rx & OTC Drugs (including homeopathic, medical gas, and repacked and relabeled drug products) (This class is full.)
Session 86 - March 26, 2012 – Bulk Ingredient/Bulk Product SPL
Session 87 - April 9, 2012 – SPL Advanced (This class is full.)
Session 88 - April 23, 2012 - Positron Emission Tomography Drug SPL
Session 89 - May 7, 2012 - New SPL Xforms (This class is full.)
Session 90 - May 21, 2012 - NDC Labeler Code/Establishment Registration SPL (This class is full.)
Session 91 - June 4, 2012 - Content of Labeling/Listing – Human and Animal Rx & OTC Drug SPL (including homeopathic, medical gas, and repacked and relabeled drug products) (This class is full.)
Session 92 - June 18, 2012 - Bulk Ingredient/Bulk Product SPL
Session 93 - September 10, 2012 - New SPL Xforms
Session 94 - September 24, 2012 - NDC Labeler Code/Establishment Registration SPL
Session 95 - October 15, 2012 - Content of Labeling/Listing – Human and Animal Rx & OTC Drug SPL (including homeopathic, medical gas, and repacked and relabeled drug products)
Session 96 - October 29, 2012 - Bulk Ingredient/Bulk Product SPL
Session 97 - November 5, 2012 - New SPL Xforms
Session 98 - November 19, 2012 - NDC Labeler Code/Establishment Registration SPL
Session 99 - December 3, 2012 - Content of Labeling/Listing – Human and Animal Rx & OTC Drug SPL (including homeopathic, medical gas, and repacked and relabeled drug products)(This class is full.)
Session 100 - December 17, 2012 - Bulk Ingredient/Bulk Product SPL (This class is full.)

 

2011 SPL Training Sessions

The 2011 SPL training sessions are scheduled Mondays from 11:30 a.m. - 12:30 p.m., ET on the following dates:

Session 50 - January 24, 2011 - NDC Labeler Code & Establishment Registration SPL (Registration Full)
Session 51 - January 31, 2011 - OTC Drug Product SPL (Registration Full)
Session 52 - February 7, 2011 - Bulk Ingredient/Bulk Product SPL (Registration Full)
Session 53 - February 14, 2011 - Prescription Drug Product SPL (Registration Full)
Session 54 - February 28, 2011 - Homeopathic Drug Product SPL
Session 55 - March 7, 2011 - NDC Labeler Code & Establishment Registration SPL (Registration Full)
Session 56 - March 14, 2011 - SPL Authoring Tool Vendors (for SPL software vendors and other interested entities)
Session 57 - March 21, 2011 - OTC Drug Product SPL (Registration Full)
Session 58 - March 28, 2011 - Bulk Ingredient/Bulk Product SPL (Registration Full)
Session 59 - April 4, 2011 - NDC Labeler Code & Establishment Registration SPL (Registration Full)
Session 60 - April 11, 2011 - OTC Drug Product SPL
Session 61 - April 18, 2011 - Bulk Ingredient/Bulk Product SPL
Session 62 - April 25, 2011 - Prescription Drug Product SPL (Registration Full)
Session 63 - May 2, 2011 - NDC Labeler Code & Establishment Registration SPL(Registration Full)
Session 64 - May 9, 2011 - Homeopathic Drug Product SPL
Session 65 - May 16, 2011 - OTC Drug Product SPL
Session 66 - May 23, 2011 - Prescription Drug Product SPL
Session 66a - May 23, 2011 - 1:30 - 2:30 p.m. - Repacker/Relabeler SPL
Session 67 - June 6, 2011 - NDC Labeler Code & Establishment Registration SPL
Session 68 - June 13, 2011 - Bulk Ingredient/Bulk Product SPL
Session 69  - June 27, 2011 - Prescription Drug Product SPL
Session 70 - September 12, 2011 - NDC Labeler Code & Establishment Registration SPL
Session 71 - September 19, 2011 - Homeopathic Drug Product SPL
Session 72 - September 26, 2011 - Prescription Drug Product SPL
Session 73 - October 3, 2011 - NDC Labeler Code & Establishment Registration SPL
Session 74 - October 17, 2011 - Bulk Ingredient/Bulk Product SPL
Session 75 - October 24, 2011 - OTC Drug Product SPL
Session 76 - October 31, 2011 - Prescription Drug Product SPL
Session 77 - November 7, 2011 - NDC Labeler Code & Establishment Registration SPL
Session 78 - November 14, 2011 - SPL Authoring Tool Vendors (for SPL software vendors and other interested entities)
Session 79 - November 21, 2011 - OTC Drug Product SPL
Session 80 - December 5, 2011 - NDC Labeler Code & Establishment Registration SPL
Session 81 - December 12, 2011 - Bulk Ingredient/Bulk Product SPL
Session 82 - December 19, 2011 - Prescription Drug Product SPL
 

 

2010 SPL Training Sessions

 

(see session descriptions in table below)

 

Session 25 - SPL Advanced - January 22, 2010
Session 26 - SPL 101 - January 29, 2010 (Registration Full)
Session 27 - SPL Advanced - February 5, 2010 (Registration Full)
Session 28 - SPL 101 - February 12, 2010 (Registration Full)
Session 29 - SPL Advanced - February 19, 2010 (Registration Full)
Session 30 - SPL 101 - February 26, 2010 (Registration Full)
Session 31 - SPL Advanced - March 5, 2010
Session 32 - SPL 101 - March 12, 2010 (Registration Full)
Session 33 - SPL Advanced - March 19, 2010
Session 34 - SPL 101 - March 26, 2010
Session 35 - SPL Advanced - April 2, 2010
Session 36 - SPL 101 - April 9, 2010
Session 37 - SPL Advanced - April 16, 2010
Session 38 - SPL 101 - April 23, 2010
Session 39 - SPL Advanced - April 30, 2010
Session 40 - SPL 101 - May 7, 2010
Session 41 - SPL Advanced - May 14, 2010
Session 42 - SPL 101 - May 21, 2010
Session 43 - SPL Advanced - May 28, 2010
Session 44 - SPL 101 - June 4, 2010
Session 45 - SPL Advanced - June 11, 2010
Session 46 - SPL 101 - June 18, 2010
Session 47 - SPL Advanced - June 25, 2010
 

Session 48 - Creating a Drug Listing SPL Document for a Product That Is Both a Cosmetic and a Drug - August 20, 2010, Web Conference, 2:30 - 3:30 p.m., ET
 

Session 49 - Preparing Homeopathic Drug Product SPL - August 20, 2010, Web Conference, 1:00 - 2:00 p.m., ET 

 

 

 

Module #

Title

Days

Time (EST)

1

SPL 101

SPL Overview

NDC Labeler Code 

Establishment Registration

Content of Labeling

Product Data Elements

Submitting SPL Documents via FDA Gateway

Fridays1:00 p.m. - 3:00 p.m., ET
2

SPL Advanced

Data Relationships

Updating SPL Data

Common Technical Errors

Scenarios

Fridays1:00 p.m. - 3:00 p.m., ET

 

2009 SPL Training Sessions

 

Session 1 – February 4, 2009 – March 11, 2009, Web Conferences
Session 2 – March 18, 2009 – April 22, 2009, Web conferences
Session 3 - May 21, 2009, Face-to-Face – Rockville, MD, Room TBD, 9:30 a.m. – 3:30 p.m.
Session 4 - February 5, 2009 - March 12, 2009, Web conferences
Session 5 - March 19, 2009 - April 23, 2009, Web conferences
Session 6 - February 23, 2009 - March 19, 2009, Web conferences
Session 7 - April 29, 2009 - June 3, 2009, Web conferences
Session 8 - June 10, 2009, Face-to-Face – Rockville, MD, Room TBD, 9:30 a.m. – 3:30 p.m.
Session 9 - April 30, 2009 - June 4, 2009, Web conferences
Session 10 - June 11, 2009 - July 16, 2009, (Thursdays - See table below for times) Web conferences (Registration Full)
Session 11 - July 30, 2009 & August 6, 2009, (Thursdays - See table below for times) Web conferences (Date Change) (Registration Full)
Session 12 - August 20, 2009 & August 27, 2009,  (Thursdays - See table below for times) Web conferences (Date Change) (Registration Full)
Session 13 - June 30, 2009 - Compressed Gas Drug Products - Electronic Drug Establishment Registration and Drug Listing in SPL Format - Face-to-Face & Web Conference – Rockville, MD, Room TBD, 10:30 a.m. – 3:30 p.m. 
Session 14 - June 19, 2009, Web Conference 9:00 - 10:30 a.m. - SPL R4 Training - Preparing Bulk Ingredient/Bulk Product Electronic Drug Listing Submissions
Session 15 - June 26, 2009, Web Conference 9:00 - 10:30 a.m. - SPL R4 Training - Preparing OTC Drug Product Electronic Drug Listing Submissions  (Registration Full)
Session 16 - June 26, 2009, Web Conference 11:30 a.m. - 12:30 p.m. - SPL R4 Training - Accelerated Course - Preparing SPL R4 Documents
Session 17 - June 26, 2009, Web Conference 1:00 - 2:30 p.m. - SPL R4 Training - Preparing Bulk Ingredient/Bulk Product Electronic Drug Listing Submissions
Session 18 - July 15, 2009, Web Conference 11:30 a.m. - 12:30 p.m. - SPL R4 Training - Preparing Repacked Drug Product Electronic Drug Listing Submissions
Session 19 - August 5, 2009, Web Conference 11:30 a.m. - 1:00 p.m. - SPL R4 Training - Preparing Combination Product Electronic Drug Listing Submissions (Date Change)
Session 20 - July 8, 2009, Web Conference 11:30 a.m. - 12:00 p.m. - SPL R4 Training - Common Errors in SPL R4 Submissions
Session 21 - July 8, 2009, Web Conference 1:00 - 2:30 p.m. - SPL R4 Training - Preparing OTC Drug Product Electronic Drug Listing Submission
Session 22 - July 28, 2009, Web Conference 11:00 a.m. - 12:30 p.m. - SPL R4 Training - Preparing Homeopathic Drug Product Electronic Drug Listing Submissions

Session 23 - September 10, 2009, & September 17, 2009, (Thursdays - See table below for times) Web conferences (NEW!)

Session 24 - October 1, 2009, & October 8, 2009, (Thursdays - See table below for times) Web conferences (NEW!)

 

***Positron Emission Tomography Drug SPL Training Session*** - Tuesday, March 8, 2011 - 1:00 - 2:30 p.m., ET

 

 

SPL Training Material

 

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) 

 

SPL Training Quick Reference (QR) eCards

SPL Training QR eCard # 1 - Very Basic Errors/Solutions for Beginners

SPL Training QR eCard # 2 - Newer/Revised Validation Procedures - Content of Labeling/Product Data Elements SPL Files