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FDA Warning Letter - Consent Decree Software Validation

Webinars - FDA Warning Letter - Consent Decree Software Validation
Webinars

By : Compliance Online

Date : 2012

Location : United States US / Palo Alto

Video 01h 17m
Description :

This webinar/training will discuss what to do to avoid additional software related compliance along with the response steps where the citations that directly or indirectly include automated system.

Keywords :

FDA warning letter, FDA inspectors, FDA-483, Compliance training, FDA software

Product/ documentation details
FDA Warning Letter - Consent Decree Software Validation

Product Type : On Demand Webinar

Author : Alfonso Fuller

Video 01h 17m

Languages : English

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.

 

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

 

Areas Covered in the seminar:

  • 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.

 

 

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.

 

Recorded webinar and reference materials will be available on your account after purchase.

FDA Warning Letter - Consent Decree Software Validation

Product Type : On Demand Webinar

Author : Alfonso Fuller

Video 01h 17m

Languages : English

Organizer : Compliance Online

ComplianceOnline is a Regulatory Affairs Professionals Society(RAPS) RA Professional Development Portal provider. ComplianceOnline is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs ComplianceOnline has agreed to follow RAPS-established operational and educational criteria