The 2 Day Conference and workshop will be mix of presentations, hands-on practical sessions, interactive workshops, case studies and Q/A sessions. Participants are encouraged to put forward their questions at the conference; these will be answered and discussed during the workshop.

 

09:30 AM - 06:00 PM
SECTION I: The fundamentals of DI
Module 1
What is Data Integrity?
  • Data, information and knowledge
  • Data types, states and lifecycle
  • Meaning and principles of Data Integrity
  • The dimensions of Data Integrity
Module 2
Primer on Part 11 and CSV
  • 21 CFR Part 11 unplugged
  • Why is Data integrity not the same as 21 CFR Part 11 and ALCOA+
  • GAMP V and system categories of GAMP V
  • Validation and the validation life cycle
  • Validation deliverables
Group exercise: Mapping DI to Part 11
SECTION II: Data Integrity Implementation program
Module 3
Data Integrity Guidance from USFDA/MHRA/EMA/WHO/PCS
  • What are similarities and differences between the guidances
Module 4
Why Data integrity issues occur?
  • Factors that cause data integrity issues to arise
  • How to proactively control these factors
  • DI framework elements in your enterprise that auditors expect to see
Module 5
Take back to work - How to implement a DI program
  • PQLI and its relevance to Data Integrity
  • What is the “Least Burdensome Approach” to establishing a DI program
  • Using 5p implementation model of Data Integrity
  • Top down design and bottoms up implementation
  • What DI SOPs do auditors want to see and what should their contents be
08:30 AM - 05:00 PM
MODULE III: Data Integrity in specific applications
Module 6
Data Integrity in the Laboratory
  • Why is laboratory Data Integrity the key focus of all regulatory audits
  • Laboratory Data Integrity audit trend and what is needed to avoid citations 
  • Core documentation that you must have to demonstrate laboratory Data Integrity
Module 7
Data Integrity in Manufacturing Automation systems
  • Data Integrity impact due to the architecture of a manufacturing automation IT system
  • What data integrity items to review for during a Electronic Batch review
  • DI citations for manufacturing automation IT systems and how to address them proactively 
  • DI susceptibilities of hybrid systems commonly found in manufacturing IT systems 
Module 8
Clinical Trials Data Integrity
  • Specific data integrity issues for clinical trial computer data
  • Paper and eCRF source data entry practices to reduce data integrity vulnerabilities
  • DI risks when generating electronic records which are true copies of paper records
  • The latest US FDA’s guidance on Data Integrity for clinical trials
Group exercise: Develop a Audit Trail design and Audit trail review SOP
MODULE IV: Auditing Data Integrity
Module 9
How is Data Integrity audited
  • Developing a Data Integrity audit checklist
  • How should you mirror your internal audits to regulatory agency audits
  • FDA’s new approaches to data integrity audits
  • DI audit and enforcement trends using most recently issued 483’s and Warning letters
Presentation of certificates