FACT News http://www.factwebsite.org/Inner.aspx?blogid=86 2012-05-17T22:56:29Z en-US Public Comments Encouraged on International Labeling Requirements http://www.factwebsite.org/Inner.aspx?id=559&blogid=86  The draft United States Consensus Standard for the Uniform Labeling of Cellular Therapy Products Using ISBT 128, Version 1.2.0, is available for public review and public comment. This document defines for the United States the areas that the ISBT 128

]]> Ramona Repaczki-Jones 2012-05-07T14:54:00Z The draft United States Consensus Standard for the Uniform Labeling of Cellular Therapy Products Using ISBT 128, Version 1.2.0, is available for public review and public comment. This document defines for the United States the areas that the ISBT 128 Standards Committee designated to be the prerogative of national authorities. It must be used in conjunction with ISBT 128 Standard Technical Specification to design labels for cellular therapy products. The 5th edition of the FACT-JACIE Cellular Therapy Standards requires organizations to have a plan for implementing ISBT 128. Accredited organizations are strongly encouraged to review this document and submit comments as necessary. ICCBBA will accept comments until June 22, 2012. Send comments to ICCBBA via email at tech.director@iccbba.org.

ISBT 128, managed by the ICCBBA, is an international standard for coding and labeling system that includes cellular therapy products. Some ISBT 128 requirements allow national variation, and the ICCBBA encourages national organizations to create their own guidance documents for the use of ISBT 128 in their countries. These documents can dictate standard policies where the ISBT 128 Standard allows national variation. An example of allowed national variation is the bar code text that appears on a product label.

The draft consensus document contains many explanations that may be helpful to organizations transitioning to ISBT 128. For additional information regarding ISBT 128 for cellular therapy, see the ICCBBA website’s cellular therapy page. 

Related Links:

ISBT 128 Standard Technical Specification

ICCBBA

]]> FACT Announces 2012 First Quarter Accreditations http://www.factwebsite.org/Inner.aspx?id=554&blogid=86 During the first quarter of 2012, two new blood and marrow transplant programs earned accreditation and four additional organizations received accreditation renewal. For additional details, click the link below for the full list.First Quarter 2012 Accreditations

]]> Jill Hempel 2012-04-18T14:54:00Z During the first quarter of 2012, two new blood and marrow transplant programs earned accreditation and four additional organizations received accreditation renewal. For additional details, click the link below for the full list.

First Quarter 2012 Accreditations

]]> Summary for the 11th Cell Therapy/FDA Liaison Meeting held on November 29, 2011 is now available! http://www.factwebsite.org/Inner.aspx?id=547&blogid=86 Participants in the meeting included AABB, AdvaMed, CAP, FACT, FDA CBER OCTGT, ISCT, NHLBI, NMDP, PACT, and USP.  View the summary.

]]> Jill Hempel 2012-03-30T14:54:00Z Participants in the meeting included: AABB, AdvaMed, CAP, FACT, FDA/CBER/OCTGT, ISCT, NHLBI, NMDP, PACT, and USP.  View the summary.

]]> Release of FACTWeb Accreditation Portal and 5th Edition Cellular Therapy Standards Published! http://www.factwebsite.org/Inner.aspx?id=536&blogid=86 FACT has released the new online FACTWeb Accreditation Portal and the 5th edition FACT JACIE International Standards for Cellular Therapy Product Collection, Processing, and Administration. For instructions on how to access these items and other relevant information, read our Special

]]> Jill Hempel 2012-03-01T14:54:00Z FACT has released the new online FACTWeb Accreditation Portal and the 5th edition FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing, and Administration. For instructions on how to access these items and other relevant information, read our Special Edition newsletter.

]]> Fifth Edition Summary of Changes http://www.factwebsite.org/Inner.aspx?id=523&blogid=86 FACT has compilied a summary of changes for the Fifth Edition of Cellular Therapy Standards that will be published March 1, 2012

]]> Jill Hempel 2012-02-15T14:54:00Z FACT has compilied a summary of changes for the Fifth Edition of Cellular Therapy Standards that will be published March 1, 2012.

]]> The Winter 2012 Newsletter is Now Available http://www.factwebsite.org/Inner.aspx?id=521&blogid=86 The new FACT newsletter is now available on the FACT Newsletter page. To sign up to receive the FACT Newsletter by email, please make sure you have a FACTWeb profile, and then subscribe to the FACT Newsletter.

]]> Jill Hempel 2012-02-15T14:54:00Z The new FACT newsletter is now available on the FACT Newsletter page. To sign up to receive the FACT Newsletter by email, please make sure you have a FACTWeb profile, and then subscribe to the FACT Newsletter.

]]> FACT Announces 2011 Fourth Quarter Accreditations http://www.factwebsite.org/Inner.aspx?id=519&blogid=86 FACT Announces 2011 Third Quarter Accreditations # During the fourth quarter of 2011, twenty five blood and marrow transplant programs earned accreditation renewal. For additional details, click the link below for the full list.  2011 Fourth Quarter Accreditations 

]]> Jill Hempel 2012-02-15T14:54:00Z During the fourth quarter of 2011, twenty-five blood and marrow transplant programs earned accreditation renewal. For additional details, click the link below for the full list.

 2011 Fourth Quarter Accreditations 

]]> The Fall 2011 Newsletter is now available. http://www.factwebsite.org/Inner.aspx?id=496&blogid=86 The new FACT newsletter is now available on the FACT Newsletter page. To sign up to receive the FACT Newsletter by email, please make sure you have a FACTWeb profile, and then subscribe to the FACT Newsletter.

]]> Jill Hempel 2011-11-29T14:54:00Z The new FACT newsletter is now available on the FACT Newsletter page. To sign up to receive the FACT Newsletter by email, please make sure you have a FACTWeb profile, and then subscribe to the FACT Newsletter.

]]> FACT Educational Outreach in Latin America http://www.factwebsite.org/Inner.aspx?id=493&blogid=86 FACT has expanded its educational training efforts to reach the cellular therapy transplant community in Latin America. The purpose of these workshops and presentations are to provide participants with the history of FACT and the importance of accreditation in Latin America,

]]> Jill Hempel 2011-11-29T14:54:00Z FACT has expanded its educational training efforts to reach the cellular therapy transplant community in Latin America. The purpose of these workshops and presentations are to provide participants with the history of FACT and the importance of accreditation in Latin America, an overview of the standards development process, preparation for accreditation, an overview of the cellular therapy standards and quality management requirements, and a discussion of the challenges of accreditation.

View a list of educational offerings in Latin America. 

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