FDA Software Validation Self-Check â€“ plan an effective Internal Audit program (FDA Validation)
Venue: Online Event
|Event Date/Time: May 09, 2012||End Date/Time: May 09, 2012|
FDA Commissioner Margaret Hamburg recently announced several new enforcement initiatives. They are certain to impact your regulatory risk profile. How will you prepare for software quality, software validation and 21 CFR part 11 planning?
Pharma, Biotech and Medical Device manufacturers are self-regulated with FDA oversight. By the time FDA come to your door, it may be too late to bring order to chaos. Companies have the responsibility to self audit to ensure compliance to GMP regulations. FDA inspectors are trained to know what to look for - you should too! Internal audits can be used for process improvement and leaning. Regular and diligent internal audits will help immunize you against severe penalties. Learn how to protect your internal audit records from FDA inspection.
Level the playing field by being prepared! Learn how to self-audit and ensure validation and software quality processes that will pass FDA scrutiny.Attendees should leave the seminar confident in being able to plan an effective internal audit program
Areas Covered in the seminar:
- Outline of FDA regulations as applied to software.
- Review of FDA software validation requirements.
- FDA inspection process.
- How to 'design to succeed'.
- Inspection preparation.
- Documentation review.
- Internal behavior review.