Best Practices for Developing Requirements for FDA-Regulated Systems

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FDA computer system validation FDA regulation
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• Best Practices for Developing Requirements for
  FDA-Regulated Systems

Carolyn Troiano
Computer system validation has been
regulated by the FDA for more than 30 years, as
it relates to systems used in the manufacture,
testing, distribution and management of a product
in the pharmaceutical, biotechnology, medical
device, animal health, tobacco and other
regulated industries. The
requirements phase of the SDLC is a key aspect of
computer system activities that must adhere to
the FDA guidelines. As such, there are specific
deliverables and tasks that must be completed and
appropriately documented. There are best
practices associated with vendor management
methodologies used in the FDA-regulated arena,
and these can be leveraged to develop a standard
and consistent approach within a company. 
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Why Should you Attend

• The attendee will learn
  how to develop a standard approach to managing
  the requirements process in a manner that
  complies with FDA guidelines for computer
  systems. Some of these people will be new to the
  concept of validation and FDA regulation, and
  will have to be coached on how to follow any
  necessary procedures required for compliance.
  There is an enormous body of
  documentation and information available that can
  be overwhelming. This course will provide a
  condensed overview of the practices that deliver
  the best results by directing the attendees to
  the most critical and cost-effective techniques
  and tools available to assure compliance when
  managing requirements-related activities. 

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Objectives of the Presentation

• The course will focus on the
  key aspects of requirements development and
  management, including best practices and
  principles for handling this key component of
  project work in an FDA-regulated environment
  (i.e., the system "touches" product during the
  manufacturing, testing or distribution of the
  product, or during any other functional
  activity).

Who can Benefit
Information technology analysts, project
managers, organizational change managers,
business process engineers, QC/QA managers and
analysts, clinical data managers and scientists,
analytical chemists, compliance managers, lab
managers, automation analysts, computer system
validation specialists, GxP training specialists,
business stakeholders and individuals who are
responsible for computer system validation
planning, execution, testing, reporting,
compliance, and audit.
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