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.

Please select the course to find a summary of its contents and an indication of those who will benefit from it.

About Zenosis

Benefits of Zenosis

Clinical Trials

Drug Safety and Pharmacovigilance


Good Manufacturing Practice

Information and Communication Technology

Medical Devices

Pharmacokinetics and Pharmacodynamics

Regulatory Affairs & Compliance

Sales & Marketing


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