FDA CFR Part 11 Compliance | Security Assessment | Compliance Services | Certification & Attestation | DIY Platform
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FDA CFR Part 11 Compliance

July 23, 2019 @ 1:00 pm - 1:45 pm


Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establish the Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES).

Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations. Part 11 also applies to electronic records submitted to the Agency under the Federal Food, Drug, and Cosmetic Act (the Act) and the Public Health Service Act (the PHS Act), even if such records are not specifically identified in Agency regulations.

Attend our free, live 45-minute webinar to learn about how FDA CFR Part 11 compliance can be achieved by following the best practices developed by our speaker and the tools that will help you achieve continuous compliance.


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Greg is an ISACA Certified Information Systems Auditor and has a rich understanding of audit and compliance regulations in the industry. Greg Manson has 18 years’ experience as an IT Director for organizations in compliant environments including healthcare, medical device, and pharmaceuticals. He has an undergraduate degree in Computer Information Systems from Indiana University and an MBA from UNC-Wilmington. He validated his experience in IT governance, risk, and compliance by successfully passing the ISACA Certified Information Systems Auditor exam in December, 2013.

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July 23, 2019
1:00 pm - 1:45 pm
Event Category:


EHR 2.0