Wednesday, August 13, 2008 - 10:30 AM
S114
Simply integrated management (SIM) approach to regulatory and quality documentation to reduce costs
• Presents the challenging myriad of regulations and standard requirements facing large-scale fermentation due to the ever-increasing regulatory burden as well as the usually broad markets served
• Proposes, as a possible solution, an approach utilizing cross-functional and operational procedures which integrate regulatory and standard compliance requirements applicable to a large scale fermentation business, with descriptive overview documents which reference the appropriate procedures
• Approach is intended to reduce an operations' burden and cost of document maintenance and training, to provide more effective and relevant compliance, and to enable faster product, organism, or site permits or other approvals, thereby expediting implementation in operations
• Proposes, as a possible solution, an approach utilizing cross-functional and operational procedures which integrate regulatory and standard compliance requirements applicable to a large scale fermentation business, with descriptive overview documents which reference the appropriate procedures
• Approach is intended to reduce an operations' burden and cost of document maintenance and training, to provide more effective and relevant compliance, and to enable faster product, organism, or site permits or other approvals, thereby expediting implementation in operations
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See more of The Annual Meeting and Exhibition 2008 (August 10 - 14, 2008)
See more of Invited Oral Papers
See more of The Annual Meeting and Exhibition 2008 (August 10 - 14, 2008)