Day 1
How did we get here?
A Data Integrity Model
Principles of data integrity
EU and FDA GMP Regulations Impacting Laboratory Data and Results
Overview of DI guidance documents
  • MHRA and WHO Data Integrity Guidances
  • FDA and PIC/S data integrity guidance documents
  • APIC data integrity guidance document
  • GAMP and PDA data integrity guidance document
  • FDA inspection findings 483 and warning letters
Principles for the Generation of Data
  • A flexible analytical data life cycle
  • Static and dynamic laboratory data
  • Observational tests and instrument tests
  • Qualified analytical instruments and validated software
  • Integrity issues
  • Application of ALCOA+ principles
Generation of Data
  • What are the requirements for data integrity?
  • Three scenarios covering
  • a paper system
  • a hybrid system
  • a client server electronic system
Processing and Reporting of Data
  • Paper / hybrid based systems
  • Networked systems with electronic records and signatures
  • Calculations and transformation of data manually and by computer applications
  • Application of ALCOA+ principles to the process
  • Calculating the reportable value and comparison with the specification
  • Paper processes versus electronic processes
  • Linkage with out of specification investigations (OOS)
Day 2

Presentation: Understanding complete data and raw data (FDA & EU terms)
Processing and Reporting of Data
  • Reviewing an analytical record
  • Scenario covering paper based records and an electronic system
Reviewing Data
  • Role of the second person review
  • Determination that the reportable result is correct
  • Identification and correction of errors for paper and electronic systems . Audit trail review
  • Do you have complete data?

WORKSHOP III: Three Data Review Mini Workshops
  • Data Review of a Paper Record
  • Audit trail review
  • Spreadsheet printout
  • Chromatographic integration and data integrity violations
  • Ten Compliance Commandments
WORKSHOP IV: Facilitated Discussion
Paper, Hybrid and Electronic Reporting Processes
Discussion of the strengths and weaknesses of reporting processes

Learning Outcomes
  • Principles of data integrity
  • Overview of Data Integrity guidance documents
  • Definition of complete data and raw data (FDA & EU terms)
  • Application of ALCOA+ principles
  • Processing and Reporting of Data
  • Data governance overview including roles and responsibilities
  • Data integrity audits and inspections
  • Chromatographic integration and data integrity violations

Go to Files below and download the announcement of the program.

The program is designed to meet the targeted training needs. Quintessence Enterprises Ltd's Quality Policy is a price contract to meet your needs to the extent that is likely to exceed your expectations.