GAMP® 5 as applied to FDA software validation - strategies to avoid warning letters

Why Should You Attend:

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 GAMP® software validation model, and the process defined in GAMP® 5 as it applies to FDA software validation. The attendee should leave the presentation confident in their ability to understand and apply the GAMP® 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 GAMP® approach.
• Advice on successful validation project staffing.
• GAMP® 5 Principles.
• GAMP® 5 as applied to FDDA software validation.
• Using GAMP® 5 to cut validation costs.