Data Integrity Fundamentals

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Data Integrity Fundamentals
www.onlinecompliancepanel.com 510-857-5896
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Instructor Profile

• Chinmoy Roy is a seasoned Life
  Sciences professional. His expertise includes the
  design, delivery and validation of industry
  compliant computerized and control systems for
  pharmaceutical and biotech manufacturing. His
  focus is on finding lean integrated manufacturing
  solutions to include Process Analytical
  Technologies (PAT), Quality by Design (QbD) and
  Quality Risk Management (QRM).Chinmoy offers
  over 30 years of US based subject matter
  expertise in the design, development, QA,
  validation and CFR 21 Part 11 implementation for
  automation and computerized systems. As principal
  Lead Engineer, Chinmoy directed several
  engineering teams to design, commission, validate
  and obtain USFDA certification for multimillion
  dollars worth of computerized control systems.
  These systems were designed to be compliant with
  CFR 21 Part 11 requirements and conformant to
  ISAs S88 and S95 standards.

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Description

• The biopharmaceutical industry
  finds itself under increasing pressure to focus
  on Data Integrity (DI). Auditors require
  companies to ensure that appropriate DI controls
  are implemented and appropriately managed
  throughout the data lifecycle. While industry
  comes to grips with the complexities of data
  integrity in their global supply chain, a series
  of webinars on DI are planned to assist your
  understanding on how to identify data integrity
  problems in your company and the steps you need
  to take to remediate them. Each webinar is
  designed to address a specific DI issue such as
  how to establish a corporate DI program, where
  does DI fit in the data lifecycle, mapping DI to
  existing predicate rules and how to design for DI
  during SDLC etc.
• Data integrity has been at the
  forefront of recent news. Regulators are
  increasingly focusing on data integrity. Audits
  are unraveling data integrity vulnerabilities
  arising from data loss during transport and data
  corruption during data storage and recall. 

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• Why Should you Attend
• This webinar will demonstrate the
  fundamental aspects of data integrity and the
  specifics of data integrity attributes. This
  understanding is essential to learn about the
  more complex issues of data integrity. 
• Objectives of the Presentation
• Become familiar with the regulatory agencies'
  perspective of Data Integrity
• Understand the meaning of Data Integrity
• How data integrity manifests itself
• What are the factors that affect Data Integrity
• What are the attributes of Data Integrity
• Review some recently issued 483s and Warning
  Letters on Data Integrity

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Who can BenefitQA, QC, Regulators, Engineers,
IT personnel, Manufacturers, Laboratory personnel

• 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
• Please let us know your thoughts and views at the
  end of webinar, your valuable feedback will help
  us improve
• 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
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www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com