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www.fda.gov
News, Guidance Documents, Dockets, Code of Federal Regulations, and International Activities
www.fda.gov/foi/warning.htm
www.fda.gov/ora/inspect_ref/igs/iglist.html
www.fda.gov/cder/guidance/guidance.htm
www.devicelink.com
Medical DeviceLink, the platform website for the medical device industry, provides news, information, employment and recruiting services, as well as collaborative opportunities for people who design, manufacture, and market medical devices.
www.clinicaltrials.gov
ClinicalTrials.gov provides regularly updated information about federally and privately supported clinical research in human volunteers.
www.nist.gov
NIST's mission is to develop and promote measurement, standards, and technology to enhance productivity, facilitate trade, and improve the quality of life.
www.astm.org
ASTM International is one of the largest voluntary standards development organizations in the world-a trusted source for technical standards for materials, products, systems, and services.
www.ispe.org
ISPE, the International Society for Pharmaceutical Engineering, is a global, not-for-profit membership organization that provides education, training, and technical publications to pharmaceutical manufacturing professionals.
www.pda.org
PDA is a non-profit international association of more than 10,500 scientists involved in the development, manufacture, quality control and regulation of pharmaceuticals/biopharmaceuticals and related products.
www.ivthome.com
The Institute of Validation Technology (IVT) publisher of the Journal of Validation Technology® and the Journal of GXP Compliance®, is dedicated to expanding the global knowledge base for validation and compliance professionals in FDA-regulated industries.
www.asm.org
American Society For Microbiology – Source of information related to the Microbiological field.
www.biospace.com
BioSpace is globally recognized as the leading provider of web-based resources and information to the life science industry.
www.usp.org
The United States Pharmacopeia (USP) is the official public standards-setting authority for all prescription and over-the-counter medicines, dietary supplements, and other healthcare products manufactured and sold in the United States.
www.fdli.org
The Food and Drug Law Institute is committed to providing high quality education and a neutral forum for the generation of ideas and discussion of law and public policy for its legal, policy and regulatory communities.
www.asq.org
The American Society for Quality (ASQ), headquartered in Milwaukee, Wisconsin, USA, is the world’s leading authority on quality since 1946.
www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=200121
This link provides access to U.S. FDA Regulations.
For User's Reference, some popular validation regulations are listed:
21 CFR Part 11 - Electronic Records;Electronic Signatures
21 CFR Part 58 - Current Good Laboratory Practice for Non-Clinical Lab Studies
21 CFR Part 210 - Current Good Manufacturing Practice (cGMPs) in Manufacturing, Processing, Packing, or Holding of Drugs; General
21 CFR Part 211 - Current Good Manufacturing Practice (cGMPs) for Finished Pharmaceuticals
www.fda.gov/ora/compliance_ref/bimo/ffinalcct.htm
This link provides access to the FDA guideline that addresses issues pertaining to computerized systems used to create, modify, maintain, archive, retrieve, or transmit clinical data intended for submission to the Food and Drug Administration.
www.fda.gov/cdrh/comp/guidance/938.html
This link provides access to the FDA guideline for medical device software validation. Although developed exclusively for medical devices, this comprehensive guideline can be applied to all software implemented in the FDA regulated industries including pharmaceutical, biotech and clinical research.
www.fda.gov/ora/compliance_ref/
This link provides access to documents, lists, policies, programs, and statements relating to Compliance References used by FDA personnel.
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