GAMPÂ® 5 as applied to FDA software validation - strategies to avoid warning letters (FDA Validation)
Venue: Online Event
|Event Date/Time: Jul 11, 2012||End Date/Time: Jul 11, 2012|
Many companies struggle with understanding what FDA, MHRA, EU and other Ministries of Health want to see regarding software validation.This presentation will review the FDA validation process, the GAMPÂ® software validation model, and the process defined in GAMPÂ® 5 as it applies to FDA software validation. The attendee should leave the presentation confident in their ability to understand and apply the GAMPÂ® 5 process.
- FDA inspectors are now being trained to evaluate software validation practices.
- Increasing use of automated manufacturing and quality systems means increased exposure
- Most recalls can be traced back to computerized equipment, exposing the validation process to scrutiny
- Corporate uncertainty leads to inaction and 'wheel spinning'
- A third of recent warning letters included citations with respect to improper or ineffective validation
Areas Covered in the seminar:
- Outline of FDA regulations as applied to software.
- Review of FDA software validation requirements.
- Why validation makes good business sense.
- Strategies on how to avoid the most common problems.
- The GAMPÂ® approach.
- Advice on successful validation project staffing.
- GAMPÂ® 5 Principles.
- GAMPÂ® 5 as applied to FDDA software validation.
- Using GAMPÂ® 5 to cut validation costs.