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  • Vladimir Veselov, Helen Roytman, and Lori Alquier: Sample Size Calculation

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    Sandra Rodriguez
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    This document contains a sample size calculation figure and references related to quality management systems and process validation for medical devices. It includes references to FDA regulations on quality systems and process validation guidance, as well as ISO and other standards on quality management, sampling procedures, and pharmaceutical development. The references provide guidance on regulatory requirements and industry standards for quality systems, process validation, software validation, and inspections for medical device manufacturers.

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    This document contains a sample size calculation figure and references related to quality management systems and process validation for medical devices. It includes references to FDA regulations on quality systems and process validation guidance, as well as ISO and other standards on quality management, sampling procedures, and pharmaceutical development. The references provide guidance on regulatory requirements and industry standards for quality systems, process validation, software validation, and inspections for medical device manufacturers.

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    © All Rights Reserved
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    7 views1 page

    Vladimir Veselov, Helen Roytman, and Lori Alquier: Sample Size Calculation

    Uploaded by

    Sandra Rodriguez
    This document contains a sample size calculation figure and references related to quality management systems and process validation for medical devices. It includes references to FDA regulations on quality systems and process validation guidance, as well as ISO and other standards on quality management, sampling procedures, and pharmaceutical development. The references provide guidance on regulatory requirements and industry standards for quality systems, process validation, software validation, and inspections for medical device manufacturers.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    of 1

    V l a d i m i r V e s e l o v, H e l e n Ro y tm a n , a n d Lo r i A l q u i e r

    Figure 4: Sample size calculation.

    REFERENCES
    1. FDA, Quality System Regulation, Title 21 Part 820 of the
    Code of Federal Regulations (www.accessdata.fda.gov/scripts/
    cdrh/cfdocs/cfcfr/CFRSearch.cfm? CFRPart=820, Apr 2003).
    2. ISO, ISO 13485:2003 Medical devices, Quality management Systems http://www.iso.org/iso/catalogue_
    detail?csnumber=36786.
    3. Doug Frank, Process Validation for a Regulated Environment, presentation http://www.scribd.com/doc/36833841/
    Process-Validation-Presentation-Final-Version
    4. GHTF SG3/N99-10 Quality Management SystemsProcess Validation Guidance, Jan. 2004.
    5. FDA, Medical Device Quality Systems Manual: A Small Entity
    Compliance Guide (http://www.fda.gov/MedicalDevices/
    DeviceRegulationandGuidance/PostmarketRequirements/
    QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/default.htm, Dec 1996).
    6. FDA, Guidance for Industry: Process Validation: General Principles and Practices (http://www.fda.gov/downloads/Drugs/
    GuidanceComplianceRegulatoryInformation/Guidances/
    UCM070336.pdf, January 2011).
    7. FDA, Guidance for Industry Part 11, Electronic Records; Electronic SignaturesScope and Application (http://www.fda.
    gov/RegulatoryInformation/Guidances/ucm125067.htm.
    g x p a n d j v t . co m

    8. FDA, General Principles of Software Validation; Final Guidance for Industry and FDA Staff (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085281.htm, Jan 2002).
    9. ISPE, GAMP 5 Good Automated Manufacturing Practices.
    10. FDA, Guide to Inspections of Medical Device Manufacturers
    (http://www.fda.gov/ICECI/Inspections/InspectionGuides/
    ucm074899.htm, Dec 1997).
    11. ICH, Q8 Pharmaceutical Development, August 2009.
    12. ASTM, E250007 Standard Guide for Specification, Design,
    and Verification of Pharmaceutical and Biopharmaceutical
    Manufacturing Systems and Equipment.
    13. ISO, 14001:2004 Environmental Management Systems.
    14. ANSI/ASQ Z1.9-2003 Sampling Procedures and Tables for
    Inspection by Variables for Percent Nonconforming.
    15. ANSI/ASQ Z1.4 Sampling Procedures and Tables for Inspection by Attributes.
    16. ANSI/ASQ S2-1995 Introduction to Attribute Sampling.
    17. Dr. Wayne A. Taylor, Guide to Acceptance Sampling, Taylor Enterprises, Inc., Lake Villa, Illinois, 1992. JVT

    Journal of Validation Technology [SPRING 2012] 91

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