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21 CFR Part 11 Risk Of Non-Compliance

2013-09-05 03:13:00| drugdiscoveryonline Downloads

When 21 CFR Part 11 took effect in August 1997, it was considered one of the most important regulations affectingpharmaceuticals, biotechnology, medical device, and other industries regulated by the FDA.

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21 CFR Part 11 Industry Overview: Ready For An FDA Inspection?

2013-09-05 03:02:29| drugdiscoveryonline Downloads

The U.S. Food and Drug Administration (FDA) issued 21 CFR Part 11 in 1997 to establish criteria for the use of electronic records andelectronic signatures by organizations that comply with the federal Food, Drug, and Cosmetic Act and the Public Health Service Act.

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The NFPA 70E and OSHA's Title 29 CFR - How Do They Relate?

2013-04-08 06:00:00| Industrial Newsroom - All News for Today

The National Fire Protection Agency’s Standard for Electrical Safety in the Workplace, NFPA 70E, is a series of guidelines rather than laws. The Occupational Health and Safety Administration (OSHA), on the other hand, is a regulatory body. OSHA’s regulations for worker health and safety are written in Title 29 of the Code of Federal Regulations (29 CFR). OSHA does not enforce NFPA 70E, and NFPA 70E is not incorporated by reference in 29 CFR, yet employers can be cited for not ...

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