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  • Mastering AutoCAD 2005 and AutoCAD LT 2005
    Mastering AutoCAD 2005 and AutoCAD LT 2005. Whether you're an AutoCAD newbie or veteran, this is your comprehensive guide to all the newest and most advanced features. Create or develop an AutoCAD drawing, import spreadsheets, master 3D modeling and rendering, secure your files, and much more.
  • Implementing File I/O Functions Using Microchip?s Memory Disk Drive File System Library
    AN1045 Implementing File I/O Functions Using Microchip's Memory Disk Drive File System Library have two electrically determined signals, card detect Author: Peter Reen and write-protect, that allow the user to determine if the Microchip Technology Inc. card is physically inserted
  • Lessons from Heparin
    By Agnes Shanley, Paul Thomas and Michele Vaccarello Wagner with Emil Ciurczak Off-site, the auditors will study the site master file (SMF) and drug master file (DMF), and inspection documents, previous audit reports and annual product quality review. Finally, auditors and their suppliers must
  • Lessons from Heparin
    cause or causes of this problem, " he says. Troubleshooting would have been much easier had the right information been on hand. Instead, the team had to redevelop information from the application, with additional information from reviewing the drug master file (DMF), to restructure the type
  • Inside USP s New Pharmaceutical Ingredient Verification Program
    not replace the DMF (drug master file). The DMF-type of information is a critical portion of the document review process, says Sheinin. Testing of random drug substance samples will take place after USP has determined the documentation is acceptable. Drug substances will be tested for label
  • SMB Takes On Paclitaxel Purification
    paclitaxel. U.S., Canadian and European Drug Master Files have been obtained for the new process. The large-scale separation of paclitaxel from cephalomannine poses several challenges, involving tradeoffs in equipment costs, separation efficiency, capacity, product yield and throughput. In addition
  • Will Pharma Ditch the Dish?
    , BioVigilant Systems, Inc. conducted USP <1223 > validation studies using low levels of standardized cultures. Results were submitted to the FDA under a Drug Master File (DMF). Any new user of the system can now refer to the DMF so that they do not have to repeat the standardized testing. However, end
  • Drug Makers Take Aim at Variability
    every major pharmaceutical company worldwide, must provide a multi-use, non-leaching, non-porous barrier for the shelf life of the products they serve. "Consequently, our manufacturing is heavily regulated. All our rubber formulations are contained in master files at FDA. " With process controls
  • [Appendix C] C.3 Documentation for masterindex<
    This documentation, and the notes that follow, are by Dale Dougherty. indexing program for single and multivolume indexing. masterindex [-master [volume]] [-page] [-screen] [filename..] generates a formatted index based on structured index entries output by . Unless you redirect output, it comes
  • Six Steps to Part 11 Compliance
    and standard operating procedures (SOPs). This also can provide features such as check-out/check-in, file locking, "mastering " the current revision and automatic revision numbering. Additionally, all transactions with the document management repository should create an audit trail to maintain

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