Quality Links

The following links are provided to assist you in improving you knowledge base. If you have any questions or would like assistance finding information on a topic not listed, please contact Aquila Consultants.

US Food and Drug Administration (FDA)

US Food and Drug Administration,
Center for Devices and Radiological Health
www.fda.gov/cdrh/index.html
Laws Enforced by FDA and Related Statutes
www.fda.gov/opacom/laws
US FDA Compliance Activities
www.fda.gov/cdrh/comp/gmp.html
US FDA Warning Letters
www.fda.gov/foi/warning.htm
US Food and Drug Administration Amendments Act of 2007
www.fda.gov/oc/initiatives/HR3580.pdf

Standards and Guidance Links

Global Harmonization Task Force
www.ghtf.org
International Organization for Standardization
www.iso.ch
International Organization for Standardization - News
www.iso.org/iso/pressrelease.htm
Regulatory Compliance Information
www.regsource.com
Engineering Documents and Standards
www.global.ihs.com
European Standardization
www.newapproach.org
National Institute of Standards and Technology
www.nist.gov

Benchmarking and Improvement

Baldridge National Quality Program
www.quality.nist.gov
Manufacturing Extension Partnership
http://www.mep.nist.gov
Automotive Industry Action Group (AIAG)
www.aiag.org/scriptcontent/index.cfm
FDA Q9 Quality Risk Management
www.fda.gov/cder/guidance/7153fnl.pdf

Professional Organizations

American Society for Quality
www.asq.org
Association for the Advancement of Medical Instrumentation
www.aami.org
Regulatory Affairs Professional Society
www.raps.org
Food and Drug Law Institute
www.fdli.org
International Society for Pharmaceutical Engineering
www.ispe.org
Advanced Medical Technology Association
www.advamed.org/mtli
Consultants Roundtable
http://consultantsroundtable.org
SAE International
www.sae.org
ASTM (American Society for Testing and Materials)
www.astm.org

Other Government Agencies

US Dept of Health and Human Services
www.hhs.gov
RCRA (Resource Conservation and Recovery Act)
www.epa.gov/rcraonline
Occupational Safety and Health Administration - OSHA
www.osha.gov