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The FDA recently announced a June 2009 implementation date for SPL Release 4, the latest update to the Structured Product Labeling (SPL) standard for submission of labeling content. This latest update expands the scope of SPL to new organizations, new content and new processes. A Glemser and EMC Documentum-based solution meets FDA requirements for electronic submissions and package inserts by enabling organizations to create and manage product labeling content and generate SPL. The presenters of this webcast will explain the new SPL 4 requirements and analyze options so that one can determine his/her company's best plan for addressing the FDA's new requirements.
- Format: Webcast
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