Disaster Recovery Best Practices for an FDA-Regulated Environment

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Disaster Recovery Best Practices for an
FDA-Regulated Environment
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• Instructor Profile
• Carolyn Troiano has more than 25
  years of experience in computer system validation
  in the pharmaceutical, medical device, animal
  health and other FDA-regulated industries. She is
  currently the ERP (Enterprise Resource Planning)
  Program Manager at the City of Richmond, VA,
  where she is overseeing the implementation of a
  large, complex system that spans more than 40
  agencies and is used by more than 4,000 City
  employees. Prior to working for the City,
  Carolyn worked directly, or on a consulting
  basis, for many of the larger pharmaceutical
  companies in the US and Europe. Carolyn was
  responsible for computer system validation across
  all regulated functions at Wyeth Laboratories,
  now part of Pfizer. She developed validation
  programs and strategies back in the mid-1980s,
  when the first FDA guidebook was published on the
  subject. While at Wyeth, Carolyn co-authored 21
  CFR Part 11, or the FDAs electronic
  record/electronic signature (ER/ES) regulation as
  part of an FDA/Industry partnership.

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• Description
• This course is intended to
  provide specific guidelines for coaching
  attendees on the best practices for disaster
  recovery of systems and data, including the
  handling of documentation.
• Computer system validation has been
  regulated by 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.
•   There are best practices 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 planning,
  executing and documenting efforts that involve
  recovery of systems and data in a manner that
  complies with FDA guidelines. Some people may 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. This is often true for IT staff, and
  is likely to be the case in companies in the
  Tobacco industry, where regulations are emerging.
• 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 activities related to handling data.

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• Objectives of the Presentation
• The course will focus on the key
  aspects of disaster recovery efforts, including
  best practices and principles for handling this
  type 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). The material will include the various
  aspects of system and data related projects, and
  the result will be a prescriptive approach to
  helping teams and individuals reach a higher
  level of compliance. FDA guidelines
  are very specific in terms of how computer
  systems are to be managed, and each company
  should have a specific strategy and methodology,
  along with a set of rigorous tactical processes
  and procedures that prescribe how participants in
  projects should be managed. 

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• 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.
• This webinar will also benefit
  any consultants, contractors or vendors
  providing products and services to the life
  sciences industries and who are involved in
  computer system implementation, validation and
  compliance.

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• Live Session - How it works
• Username and Password will be sent to you 24
  hours prior to the webinar
• Presentation handouts in pdf formate will be
  mailed to you
• Login to the session using the username and
  password provided to you
• Get answer to your queries through interactive
  QA sessions via chat
• Please let us know your thoughts and views at the
  end of webinar, your valuable feedback will help
  us improve
• Get certification of attendance.
• Recorded Session - How it works
• A link will be provided to you upon purchase of
  the recorded session
• Please click on the link to access the session
• Presentation handouts in pdf formate will be
  mailed to you
• Get certification of attendance.

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