Utilization of a Life-cycle Validation Approach

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

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

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