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Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered ...
Requirements for pasteurization of milk. Interstate shipment of turtles as pets. Interstate shipment of African rodents that may carry monkeypox. Sanitation on interstate conveyances (i.e. airplanes and ships) 1271 Requirements for human cells, tissues, and cellular and tissue-based products (i.e. the cGTPs).
Title 21 has 26 chapters: 21 U.S.C. ch. 1 — Adulterated or Misbranded Foods or Drugs (§§ 1—26) 21 U.S.C. ch. 2 — Teas (repealed) (§§ 41–50) 21 U.S.C. ch. 3 — Filled Milk (§§ 61–64) Filled Milk Act. 21 U.S.C. ch. 4 — Animals, Meats, and Meat and Dairy Products (§§ 71–149) 21 U.S.C. ch. 5 — Viruses, Serums, Toxins ...
A few volumes of the CFR at a law library (titles 12–26) In the law of the United States, the Code of Federal Regulations (CFR) is the codification of the general and permanent regulations promulgated by the executive departments and agencies of the federal government of the United States. The CFR is divided into 50 titles that represent ...
Since June 20, 1979, the FDA has received many questions about Good Laboratory Practice (GLP) regulations (21 CFR 58). The responses to these inquiries are stored in the Dockets Management Branch (HFA-305) and shared with the Agency's Bioresearch Monitoring (BIMO) program managers and district offices to ensure consistency.
Electronic lab notebook. An electronic lab notebook (also known as electronic laboratory notebook, or ELN) is a computer program designed to replace paper laboratory notebooks. Lab notebooks in general are used by scientists, engineers, and technicians to document research, experiments, and procedures performed in a laboratory.