Search Results for '21 CFR Part 11'

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  • Norwich Pharma Services

    Norwich Pharma Services

    October 20, 2014
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  • The Audit Trail Advantage

    The Audit Trail Advantage

    Carol Brandt , GMP Compliance Consulting, NNE Pharmaplan || September 8, 2014
    Why one of FDA’s most misunderstood rules can help ensure data integrity and compliance, and help in root cause analysis

  • ERP Selection

    ERP Selection

    Jay Deakins, Deacom || March 6, 2013
    Considerations for pharma manufacturers

  • 21 CFR Part 11

    February 27, 2012
    Title 21, Code of Federal Regulations, Part 11. Part 11 established the criteria under which electronic records and signatures will be considered equivalent to paper records and handwritten signatures in manufacturing processes regulated by the FDA.…

  • Code of Federal Regulations, Title 21

    February 27, 2012
    The U.S. regulations that directly apply to biopharmaceutical development are contained in Title 21 parts 58 (Good Laboratory Practice for Nonclinical Laboratory Studies), 210 (Current Good Manufacturing Practice in Manufacturing, Processing, Packing…

  • 21 CFR 11 Enforcement

    John Avellanet || September 7, 2011
    Where is the FDA headed?

  • Quality Assurance and Good Lab Practice

    Quality Assurance and Good Lab Practice

    Paul Swidersky || May 2, 2007
    Examining the FDAs and OECDs GLPs

  • 21 CFR Part 11 Update

    Kristin Brooks || August 23, 2005
    The risk-based revolution in IT

  • Electronic Records & Electronic Signatures

    Suggy S. Chrai || August 22, 2005
    21CFR11 and process validation