We hope you find these links useful. Please let us know if there are additional sites that should be added to this reference list.

Regulatory Sites

       

U.S. Food and Drug Administration (FDA)

FDA Center for Drug Evaluation and Research (CDER)

FDA Center for Devices and Radiological Health (CDRH)

FDA Center for Biologics Evaluation and Research (CBER)

U.S. Environmental Protection Agency (EPA)

Health Canada

Medicines and Healthcare products Regulatory Agency (MHRA) UK

European Medicines Agency (EMEA)

 

Regulations, References, and Guidance Documents

 

Federal Register (1994+)

21 CFR Part 11 - Electronic Records; Electronic Signatures

21 CFR Part 58 - Good Laboratory Practice for Nonclinical Laboratory Studies

21 CFR Part 203 - Prescription Drug Marketing Act

21 CFR Part 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals

21 CFR Part 820 - Medical Device Quality System Regulation

40 CFR Part 160 - EPA GLPs: Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)

          40 CFR Part 792 - EPA GLPs: Toxic Substances Control Act (TSCA)

EPA Cross-Media Electronic Reporting and Recordkeeping Rule (CROMERRR)

Health Insurance Portability and Accountability Act of 1996 (HIPAA)

FDA Guidance Documents

General Principles of Software Validation

Guidance for Off-the-Shelf Software used in Medical Devices

Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, 05/1998

Guide to Inspections of Quality Systems, 08/1999

Computerized Systems used in Clinical Trials, 04/1999

Good Automated Laboratory Practices (GALPs)

Dockets

Compliance Policy Guides

Frequently requested ORA documents and FDA 483s

Warning Letters

 

Standards and Industry/Professional Associations

 

American Chemical Society (ACS)

American National Standards Institute (ANSI)

American Society for Quality (ASQ)

Association for Computing Machinery (ACM)

Biotechnology Industry Organization

British Association of Research Quality Assurance (BARQA)

Drug Information Association (DIA)

Good Automated Manufacturing Practice (GAMP) Forum

Institute of Electrical and Electronic Engineers (IEEE)

International Conference on Harmonisation (ICH) Guidelines

International Society for Pharmaceutical Engineers (ISPE)

International Organization for Standardization (ISO)

Mid-Atlantic Region of SQA (MARSQA)

National Institute of Standards and Technology (NIST) Information Technology Lab

Organisation for Economic Co-operation and Development (OECD)

Pacific Region of SQA (PRCSQA)

Parenteral Drug Association (PDA)

Pharmaceutical Research and Manufacturers of America (PhRMA)

Regulatory Affairs Professionals Society (RAPS)

Society of Quality Assurance (SQA)

Society for Software Quality (SSQ)

Software Engineering Institute (SEI)

 

Online Resources/References

 

21 CFR Part 11 (Waters Laboratory Informatics)

Applied Clinical Trials

Bio Online

          BioPharm

CATO Research

Digital Signature Law

Labcompliance (Dr. Ludwig Huber)

Medical Device and Diagnostic Industry (MDDI) / Medical Device Link

          Medical Product Outsourcing

Pharmaceutical Processing Online

Pharmaceutical Technology

Pharmalicensing

PharmWeb

Quality Digest

Quality Resources Online

Read-Out Instrumentation Signpost

RegSource (Regulatory Information)

Training and Seminar Locator

 

     

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Last modified: Jan 15, 2007