FDA Warning Letter - Consent Decree Software Validation

Why Should You Attend:

FDA inspectors are now being trained to evaluate software validation practices. Increasing use of automated manufacturing and quality systems have increased exposure. Most recalls can be traced back to computerized equipment, exposing the validation process to scrutiny. A third of recent warning letters included citations with respect to improper or ineffective validation. Computerized quality system tracking systems are subject to increased scrutiny during compliance and enforcement actions and hence incomplete software validations are ticking time bombs.

Once the FDA inspectors or Fedral marshalls have arrived, it's time to set up an effective software validation and software quality program - even if those were not the original citations that brought you to FDA's attention. Attend this Webinar if you have received, expect or fear an FDA-483, Warning Letter or Consent Decree. Learn steps that can be done proactively and forward plan to prevent additional software related compliance issues and how to prepare response where citations directly or indirectly include automated system.

Areas Covered in the Webinar:

• Outline of FDA regulations as applied to software.
• Review of FDA software validation requirements.
• Review of FDA software expectations.
• Proactive steps to prevent additional software-related compliance and enforcement problems.
• Response steps where inspection citations directly or indirectly include automated systems.
• Forward planning.
• What to do about existing systems.
• The paradox of ongoing validation work.

Who will benefit:

This seminar will give valuable help to FDA regulated Pharmaceutical, Medical Device, Biotech, Diagnostics and Biological manufacturers who have received, expect or fear an FDA-483, Warning Letter or Consent Decree. The staff members who will benefit include:

• Internal auditors
• External auditors
• Remediation personnel
• Quality Assurance personnel and management
• SQA - Software Quality personnel
• Consultants
• Business managers responsible for system compliance
• IT / IS managers
• Regulatory affairs personnel and management
• Third-party certifier personnel

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.