Data Integrity
Data governance and Quality Metrics

Lecturer: Ms. Karen Ginsbury

Date: 23 July 2018
Location: Kfar Maccabiah, Ramat Gan
General Information
Duration: 1 - Day Course
Hours: 09:00 – 17:00
Price: 1,950 NIS + VAT
Credit Points: 1
SKU: 18808
Course Language: Hebrew
About the Course
More and more inspections around the world seem to be uncovering data integrity issues.  Do you perform data integrity audits? Do you have a data governance policy?  Do you think the topic is limited to the QC laboratory and / or computerized systems audit trails and passwords?  This workshop will allow you to benchmark your company against others and set up or improve a holistic, proactive Data Governance System which is a part of the Quality System rather than just an add-on.
Who should attend
Anyone working in the pharmaceutical industry including Company General Managers, Managing Directors (GMPs and ICH Q10 focusing on management leadership), QPs, Quality Assurance, Quality Control and other quality professionals, Operations Managers, production managers, Research and Development, persons working in technology transfer, personnel working in pharmaceutical Active substance and finished product manufacture as well as distributors, brokers, wholesale dealers and anyone involved in the manufacture of starting materials, Active Substances, finished pharmaceuticals or involved in the handling, processing or sale or administration of any of these.  Persons involved in clinical trials and manufacture and administration of Investigational Medicinal Products will also find the course very useful as will regulatory personnel.
Data Integrity
Data governance and Quality Metrics
Benefits to the Participants
Participants will come away from this course understanding what data integrity issues are, how they arise and how a comprehensive Data Governance Policy can reduce the likelihood of systematic data integrity problems in a company.
Participants will understand how to plan for the future and integrate automated solutions to reduce dependence on “human error.”
Contact us
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Issues to be covered
  • Data integrity: definition and warning letters / case studies
    we all have this problem…
  • Guidance: ALCOA
    • MHRA Data Integrity Guidance
    • EMA August 2016 Q&A on Data Integrity
    • PIC/s draft: Good Practices For Data Management And Integrity In Regulated GMP/GDP Environments
    • FDA draft Questions and Answers on Data Integrity
    • WHO draft: Good Data and Record Management Practices
  • Data governance plan
    • Back-dating, Real-time recording (or lack of)
    • Educating for data governance: create, sustain, monitor and improve data integrity throughout the organization: DI SWAT teams and waving the DI flag
    • Moving from unconscious incompetence to unconscious competence and maintaining control
    • Computers vs paper and environment:
      automated solutions
    • Batch records and data integrity issues
    • Deviations and CAPA and data integrity
  • Quality Unit role vs rest of management in data integrity
  • Company culture and governance
  • Conducting a Data integrity gap analysis
    • internal audit program
  • Integrating Data Governance and DI MANAGEMENT into the Quality System
About The Lecturer

Ms. Karen Ginsbury

Karen Ginsbury is a London, UK trained pharmacist with a second degree and passion for microbiology. With hands-on experience of cleanroom management, Karen has over 27 years of experience in the pharmaceutical industry working at setting up, implementing and continuously improving quality systems. Karen is an experienced risk management facilitator as well as a lively and highly interactive lecturer.
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