Business Continuity Best Practices for an FDA-Regulated Environment

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• Business Continuity 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.

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• Description
• This course is intended to
  provide specific guidelines for coaching
  attendees on the business continuity best
  practices when systems and data fail, 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.

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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 day-to-day business operations 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. It's
  important to look at what are some of the threats
  and challenges, and what methods you can use to
  mitigate these.

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• Objectives of the Presentation
• The course will focus
  on the key aspects of business continuity
  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 issues that
  force an organization to revert to backup
  operations, 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 format 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
• 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 format will be
  mailed to you
• Get certification of attendance.

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• Get Connected With Us

www.onlinecompliancepanel.com
www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com