Source: https://www.compliance4all.com/control/w_product/~product_id=502097LIVE?channel=meetings4docs_Sep_2018_SEO
Timestamp: 2019-06-18 07:28:09
Document Index: 18076544

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

21 CFR Part 11 | Enforcement Practices | Manufacturing - Courses
FDA continues to enforce Part 11 through its new 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 webinar will have the answers. In addition, 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.
Checklist: Part 11 compliance
Case Studies: How to avoid Part 11 related 483's and Warning Letters
SOP: Electronic Audit trail: Specifications, Implementation, Validation