Source: https://webinarcompliance.com/product/fdas-new-enforcement-of-21-cfr-part-11-ludwig-huber-fdb2852/
Timestamp: 2019-02-23 20:39:00
Document Index: 89073957

Matched Legal Cases: ['art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11']

FDA’s New Enforcement of 21 CFR Part 11 – Webinar Compliance
Product Id : FDB2852
FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings. The seminar will have the answers. And using industry proven case studies on how to avoid 483 inspectional observations and warning letters attendees will learn how to prepare their organization for trouble-free Part 11 related inspections.
FDA’s current inspection and enforcement practices
FDA’s new interpretation: learning from FDA inspection reports
FDB2852
Product #21408 FDA's New Enforcement of 21 CFR Part 11