Overview:
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 related observations. Citations are related to inadequate integrity, security and availability of electronic records, including data manipulation.
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 related observations. Citations are related to inadequate integrity, security and availability of electronic records, including data manipulation.
Speakers
Ludwig Huber,
Who Should Attend
- IT Managers and System Administrators
- QA Managers and Personnel
- Validation Groups
- Software Developers
- Validation Professionals
- Training Departments
- Documentation Department
- IT and GMP Consultants
