Information and Communication Technology

Our course on US Regulation 21CFR11 explains what needs to be done to ensure that computer systems in environments regulated by the Food and Drug Administration (FDA) comply with the regulation.

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Our module ICT01 clarifies the complicated picture of regulatory requirements and enforcement discretion applying to computer systems operated by companies that market or intend to apply for approval to market drugs or medical devices in the USA and by suppliers to those companies.

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Regulatory Affairs & Compliance

Clinical Trials

Good Manufacturing Practice

Drug Safety and Pharmacovigilance

Pharmacokinetics and Pharmacodynamics

Information and Communication Technology

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