Metrology Links Reference List

METROLOGY LINKS

  1. American Association for Laboratory Accreditation
  2. American Measuring Tool Manufacturers Association
  3. American National Standards Institute
  4. American Society for Testing and Materials
  5. International Organization for Standardization
  6. Instrumentation, Systems, and Automation Society (ISA)
  7. National Conference of Standards Laboratories (NCSL)
  8. National Institute of Standards and Technology
  9. National Voluntary Laboratory Accreditation Program (NVLAP)
  10. Cal Lab Magazine

FDA LINKS

  1. FDA Home Page
  2. Code of Federal Regulations
  3. FDA Modernization Act of 1997 (FDAMA)
  4. FDA Talk Papers
  5. Freedom of Information (FOI)
  6. Electronic Reading Room
  7. Center for Biologics Evaluation and Research
  8. CDER Handbook
  9. cGMP
  10. Human Drug Current Good Manufacturing Practice Notes
  11. Office of Regulatory Affairs

 

OTHER HELPFUL LINKS

  1. American Society for Quality (ASQ)
  2. American Society of Mechanical Engineers
  3. DIA —Drug Information Association
  4. FM Global Technologies LLC
  5. International Society for Pharmaceutical Engineering (ISPE)
  6. Quality Magazine
  7. PDA —Parenteral Drug Association
  8. U.S. Pharmacopeia

FDA

  1. 820.72 Access Data FDA
  2. Regulatory Requirements for Medical Device Calibration Programs
  3. Measure for Measure: Where Does It Say That? – ASQ
  4. FDA GMP 820.60/61
  5. Validation and Calibration Definitions and Terminology
  6. Pay Close Attention To Equipment Calibration Certificates, FDA Says
  7. GMP 11 Good Measurement Practice for Assignment and – NIST
  8. GMP-compliant Maintenance & Calibration
  9. PTS – GMP Compliant Calibration Programs
  10. Tutorial – 21 CFR Part 11 – Electronic Records/Electronic Signatures
  11. Process Validation: General Principles and Practices
  12. Inspections – Food and Drug Administration
  13. Process Validation: Practical Aspects of the “New” FDA Guidance
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