Paul Nicholson Consulting Home Page

FDA LINKS

Code of Federal Regulations

FDA Guideline for General Principals of Software Validation

21 CFR Part 11 Electronic Records/Electronic Signatures Latest Guidance Document

FDA Guideline for Computerized Systems Used in Clinical Trials

FDA Modernization Act of 1997 (FDAMA)

FDA Talk Papers

Freedom of Information

FOI, Electronic Reading Room

Center for Biologics Evaluation and Research

Human Drug Current Good Manufacturing Practice Notes

Office of Regulatory Affairs

Other helpful links

American Society For Quality (ASQ)

American Society of Mechanical Engineers

DIA - Drug Information Association

FM Global Technologies LLC

International Society for Pharmaceutical Engineering (ISPE)

Quality Magazine

PDA - Parenteral Drug Association

U.S. Pharmacopeia

METROLOGY LINKS

American Association for Laboratory Accreditation

American Measuring Tool Manufacturers Association

American National Standards Institutes

American Society for Testing and Materials

International Organization for Standards

International Society for Measurement and Control

National Conference of Standards Laboratories (NCSL)

NCSL International

National Institute of Standards and Technology

National Voluntary Laboratory Accreditation Program (NVLAP)

Cal Lab Magazine