This document discusses an upcoming training on FDA software validation related warning letters. It notes that FDA inspectors are increasingly scrutinizing software validation practices during inspections as automated systems have become more prevalent in manufacturing and quality systems. A third of recent warning letters included issues with improper or ineffective software validation. The training will cover FDA regulations and expectations around software validation, proactive steps to prevent compliance issues, and how to respond when inspection findings involve automated systems. The training will benefit those working in quality assurance, software quality, IT, and regulatory affairs at FDA-regulated companies.

1. FDA Warning Letter - Consent Decree Software Validation
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 that
directly or indirectly include automated system.
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 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.

2. 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