Webinars > All COMPLIANCE Categories > Compliance Courses Webinars 21 CFR Part 11 - Compliance for Electronic Records and Signatures WebinarThis webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to greatly increase productivity, and explains about the regulation and how it applies to computerized systems. Course Description/Agenda21 CFR Part 11 - Compliance for Electronic Records and Signatures Overview:
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained. FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient. FDA has set up regulations that address both data security and patient safety. We will show how 21 CFR part 11 considers both.
Areas Covered in the Session:
Who Will Benefit:
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.
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