Auditing Laboratory Data Systems

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• Auditing Laboratory Data Systems

Auditing
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• Instructor Profile
• Dr Mark Powell is a Fellow
  of the Royal Society of Chemistry (RSC) with over
  20 years' experience as a senior analytical
  chemist. He is a member of the RSC's Analytical
  Division Council and chairs their working group
  on Continuing Professional Development. Until
  September 2013, he was Scientific Manager for a
  pharmaceutical CRO specializing in early-stage
  drug development. He left that job to set up Mark
  Powell Scientific, a company that offers training
  and consultancy services in analytical chemistry.

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• Description
• The effective auditing of
  laboratory data systems is essential in order to
  ensure that the expectations of regulatory
  agencies are met. This webinar will provide
  details of the most common non-conformances and
  provide staff members, who are unfamiliar with
  laboratory computer systems with an understanding
  of the controls that are necessary to ensure the
  integrity of analytical data.

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• Objectives of the Presentation
• The objectives of the
  presentation are to cover areas such as
• Categories of laboratory data system (GAMP)
• Lifecycle management, archiving and backup
• What counts as raw data?
• Protecting the integrity of analytical data
• General guidance on assigning user privileges
• Operating system configuration.
• Application configuration
• Controls appropriate for chromatography data
  systems
• Practices that aid compliance with data integrity
  
• requirements
• Examples from recent FDA warning letters

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• Why Should you Attend?
• The webinar will teach
  participants the importance of correct data
  system configuration and what to look for during
  the audit. Businesses will benefit by reducing
  the risk of regulatory action as a result of
  failure to comply with current expectations. 
• Who can Benefit?
• Staff who are required to audit analytical
  operations who do not have a chemical QC
  background.
• Auditors who require updating on current
  regulatory expectations.
• QC staff who needs help in regulatory compliance.
• Staff who would like to understand the
  implications of data integrity for laboratory
  data systems.

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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
• 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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• Get Connected With Us

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