Lab Data Integrity, Part 2 PLUS GMP Data Governance

Lab Data Integrity, Part 2 PLUS GMP Data Governance

Copenhagen, Denmark

Course No 16607


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Lab Data Integrity:

Dr Christopher Burgess, Chairman of the ECA Analytical Quality Control Working Group
Dr Bob McDowall, Member of the ECA IT Compliance Interest Group<
Dr Franz Schönfeld, GMP Inspector, Germany

GMP Data Governance:

Dr Christopher Burgess, Chairman of the ECA Quality Control Group
Klaus Eichmüller, Wolnzach c/o Regional Council Darmstadt, GMP Inspectorate, Germany
Dr Bob McDowall, Member of the ECA IT Compliance Interest Group
Roland Miksche, Vienna, Austria
Margarita Sabater, Member of the ECA Data Integrity Group
Philip Vaering, QA Chemist, ALK-Abelló A/S, Denmark


Lab Data Integrity - Meeting FDA & EU Concerns


  • Laboratory Data & Results: EU and US GMP Requirements, MHRA and WHO Data Integrity Documents, FDA Guidance Documents
  • Inspection Findings: 483 and Warning Letters
  • Dealing with Mistakes before they become Falsification or Fraud
  • Principles of Data Management
  • Understanding and Applying ALCOA+ Principles to Laboratory Data
  • Second person review of analytical records
  • Requirements for Raw Data Integrity for Paper Records, Hybrid Systems, Electronic Systems incl. ELNs
  • Audit of Analytical Records
  • Data Transformation: How to Identify and Handle Transcription Errors
  • Collation and Reporting of Results

GMP Data Governance - Principles for Data Integrity Assurance

  • Definitions of Data Governance
  • Regulations and Regulatory Guidance for Data Handling -
  • Expectations of an EU GMP Inspector
  • Case Study: Corporate Data Integrity Policy
  • Data Governance Roles and Responsibilities
  • Case Study: Corporate Culture and Organisation for Data Governance and Data Integrity
  • Data Owners versus Data Stewards
  • Changing the Culture of an Organisation
  • Data Integrity Training
  • Data Integrity Audits of Processes and Systems
  • Investigating Data Integrity Violations
  • Auditing a System and Identifying Data Integrity Problems

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