Utilization of a Life-cycle Validation Approach - PowerPoint PPT Presentation

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Utilization of a Life-cycle Validation Approach

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This webinar will detail how to implement tools that will result in a more responsive cost-efficient approach to validation activities. – PowerPoint PPT presentation

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Title: Utilization of a Life-cycle Validation Approach


1
  • Utilization of a Lifecycle Validation Approach
    Via a Quality System to Reduce cost and Increase
    Compliance

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
2
  • Instructor Profile
  • James Carron, has a BS in
    Chemistry/ Mathematics from Missouri State
    University who has over 26 years of industry
    management experience including Validation,
    Quality Control, Quality Assurance, and Research
    and Development, and Supply Chain. His experience
    includes pharmaceuticals (aseptic and solid
    dose), medical devices, and biotech products. 
    Most recently spent the last six years
    doing the Quality oversight for Amgen SAP
    implementation. Currently is an independent
    consultant in the areas of compliance,
    validation, Quality assurance and Quality control
    as well as constructing cost containment cost
    control strategies. 

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
3
  • Description
  • The great approach by the author
    where he does give us the information about
    Utilization of a Lifecycle Validation Approach
    Via a Quality System to Reduce cost and Increase
    Compliance and will detail how to implement tools
    that will result in a more responsive
    cost-efficient approach to validation activities.
    This approach will allow for better senior
    management accountability and corporate
    governance as well as the identification of
    responsible (accountable stakeholders)
    individuals for these validated processes.

Compliance
www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
4
  • Why Should you Attend
  • The FDA in January 2011 published an
    updated guidance on process validation. This
    guidance addresses a lifecycle approach to
    validation that addresses validation
    incorporating the product lifecycle. This
    presentation addresses how to take advantage of
    the guidance to facilitate transition from RD
    into a production setting. 

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
5
  • Objectives of the Presentation
  • Objectives of the presentation
    are to cover areas topics on
  • Incorporation of ICH Q8, Q9 and Q10 into your
  • development processes.
  • Where and how to incorporate into existing
    projects.
  • Pilot phase
  • Scale-up phase
  • PPQ phase
  • Continuous verification phase/implementation
  • of a Continuous improvement strategy
  • Benefits
  • Governance oversight (Executive Accountability)
  • Case Studies

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
6
  • Who can Benefit
  • Research and Development Project Managers
  • Senior Management Executives
  • Technical transfer professionals
  • Operations Executives
  • Supply Chain Executives
  • Quality Assurance Executives
  • Regulatory Compliance Associates and Managers

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
7
  • 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.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
8
  • Get Connected With Us

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