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

bulletRegulatory Sites
bulletRegulations, References, and Guidance Documents
bulletStandards and Industry/Professional Associations
bulletOnline Resources/References

 

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