Pharmaceutical:

Pharma is highly regulated industry. The Food and Drug Administration (FDA) is the main regulator but numerous regulatory bodies affect training in the industry. Common training requirements derive from the following:

CFR Part 11
The FDA issued regulations that provide criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic signatures and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper.
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GxP
This refers to the "Good Practices" whose rulings are observed within the pharmaceutical industry. These are Good Laboratory Practice (GLP), Good Automated Manufacturing Practice (GAMP), Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP). The 'x' is merely a placeholder.

 

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