Lab Data Integrity, Part 1 & 2 PLUS GMP Data Governance
19-23 March 2018, Copenhagen, Denmark
Course No. 16608
Speakers
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
Programme
Lab Data Integrity - Meeting FDA & EU Concerns
PROGRAMME
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
PROGRAMME
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
This course is part of the GMP Certification Programme "ECA Certified Data Integrity Manager" Learn more
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