FDA Warning Letter - Consent Decree Software Validation

Duration: 60 Minutes
This training on FDA software validation related warning letters will discuss what to do to avoid additional software related compliance issues along with the response steps where the citations directly or indirectly include automated system.
FDA Warning Letter
Instructor: Alfonso Fuller
Product ID: 501955
Objectives of the Presentation
  • 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
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 Federal marshalls have arrived, it is 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.

Who will Benefit
This webinar 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
$375
Recorded Session for one participant
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  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Alfonso Fuller is the President of Fuller Compliance, Inc., a consulting firm that specializes in FDA quality system, software validation and software quality for pharmaceutical, biotech and medical device, nutraceutical and food manufacturers. He is a consultant, writer, and frequent presenter nationwide on quality system and software quality issues. His speaking appearances have included numerous national and statewide conferences.
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