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

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Jul 11, 2012 End Date/Time: Jul 11, 2012
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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.


Online Event
2600 E. Bayshore Road
Palo Alto
United States