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 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. To learn more about GAMP®, visit www.ispe.org

Instructor Profile:

Alfonso Fuller, is the founder and President of Fuller Compliance, a consulting firm that specializes in FDA quality system, software quality and software validation for pharmaceutical, biotech and medical device companies. Al is the author of several white papers, has spoken at numerous seminars, and has represented many clients before FDA compliance and enforcement personnel, and actively consults on day-to-day compliance issues.