The 6 Most Common Problems in FDA Software Validation and Verification

Why Should You Attend:

• 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.

Many companies struggle with understanding how to avoid major mistakes when validating software to FDA standards. This presentation will review the validation planning process with particular emphasis on avoiding six common pitfalls. The attendee should leave the presentation confident in their ability to improve the level of validation success.

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.
• The 6 Most Common Problems in FDA Software Validation & Verification.
• Strategies on how to avoid the most common problems.
• Advice on successful validation project staffing.

Who Will Benefit:

This webinar 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
• QA / QC managers, executives and personnel
• IT / IS managers and personnel
• Validation specialists
• Software quality reviewers
• Consultants

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. Mr. Fuller 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.