Quality Engineering
ASQ
The American Society for Quality. A world leader in quality standards and professional certifications.
ISPE
The International Society of Pharmaceutical Engineers. A wealth of resources for pharmaceutical manufacturing professionals.
IVT
The Institute of Validation Technology. Resources for Validation and Compliance professionals in FDA related industries.
Six Sigma
A wealth of online resources for Six Sigma projects and impelmentation
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FDA Resources
(21 CFR Part 11)
The most current information on Electronic Records and Electronic Signatures from the source of the rule.
Guidance Documents Web Page
These FDA CDERGuidance documents represent the Agency's current thinking on a particular subject.
FDA's Electronic Reading Room
Read current FDA Warning Letters and responses
FDA Regulatory Procedures Manual
The Regulatory Procedures Manual is a reference manual for FDA personnel. It provides FDA personnel with information on internal procedures to be used in processing domestic and import regulatory and enforcement matters.
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International Resources
EMEA Home
Current information from the European Medicines Agency
Ministry of Health, Labor and Welfare
Current information from the Japanese authorities
Intl. Conference on Harmonisation
Information on Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
World Health Organization GMPs
Information on WHO Quality Assurance standards for pharmaceuticals |
