This GAMP® 5 training/Webinar will discuss on the GAMP® software validation model and the defined process of GAMP® 5 as it applied to FDA software validation.
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 Webinar:
- 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.
Who Will Benefit:
This seminar will give valuable help to FDA regulated Pharmaceutical, Medical Device, Biotech, Diagnostics and Biological manufacturers. The staff members who will benefit include:
- System owners - responsible for keeping individual systems in validation
- Policy makers fof software validation and software quality
- Software development life cycle (SDLC) personnel
- QA/QC managers, executives and personnel
- IT/IS managers and personnel
- Validation specialists
- Software quality reviewers
- Consultants
- NOTE: GAMP® is a registered trademark of ISPE.
Course Provider
Alfonso Fuller,
