Auditing Laboratory Data Systems - PowerPoint PPT Presentation

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Auditing Laboratory Data Systems

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The webinar will teach participants the importance of correct data system configuration and what to look for during the audit. – PowerPoint PPT presentation

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Title: Auditing Laboratory Data Systems


1
  • Auditing Laboratory Data Systems

Auditing
www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
2
  • 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.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
3
  • 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.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
4
  • 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

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
5
  • 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.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
6
  • 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.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
7
  • Get Connected With Us

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