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Two Day Training Course : Current Issues in Assuring Data Integrity in Life Sciences (San Diego, CA, United States - April 25-26, 2018) -
[February 23, 2018]

Two Day Training Course : Current Issues in Assuring Data Integrity in Life Sciences (San Diego, CA, United States - April 25-26, 2018) -

The "Current Issues in Assuring Data Integrity in Life Sciences" conference has been added to's offering.

Data Integrity is a major concern of regulatory agencies worldwide as evidenced by the increasing number of Warning Letters issued in that area. Some managements have proceeded to implement data integrity programs on the lines of those implemented in big data. This has resulted in the escalation of costs and it is disproportionate to the benefits gained. Some even wonder why they continue to receive Warning Letters in spite of spending the dollars to implement programs such as Data Governance etc. etc.

This training focuses on implementing Data Integrity programs using the least burdensome approach, a technique that regulators themselves employ to conduct their audits. The training also addresses the evolving concepts and guidance from regulatory agencies such as the recently issued industry guidance on Part 11 for Clinical Investiations among many others.

Addressed will be case studies, inspection approaches, and trends in the issuance of data integrity 483s and warning letters in the recent past. Take back to your work, samples of Data Integrity related directives and SOPs such as Data Integrity Policy, Maintenance of Electronic Records directive and many more that are required to establish a data integrity infrastructure in your company.

This workshop is for novices as well as experienced personnel from QA, IT, manufacturing, regulatory and validation groups. It addresses data integrity issues in all life science industry sectors where data is required to fulfill regulatory requirements. These sectors include medical devices, biologics manufacturing, quality control laboratories, clinical trials, blood establishments, compounding pharmacies etc.

Areas Covered:

  • What is Data integrity
  • Data Life Cycle design and controls
  • Elements of a Data Integrity Assurance program
  • Roles and responsibilities of different groups in ensuring data integrity
  • What data integrity SOPs do auditors expect to see during audits
  • Validating Data Integrity

Learning Objectives:

  • Some advanced Data Integrity topics include:
  • Data Integrity triad
  • Data Integrity Maturity Model
  • Developing critical thinking skills
  • Data Integrity Audit trends

For more information about this conference visit

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