Data Integrity Course

GMP in-house Training Courses are an ideal solution for ten or more people and are very cost-effective. We come to you at a time and date to suit your organisation.

Please contact us if you are interested in a detailed offer.

The agenda proposal aside has been developed for an in-house training course (group of participants). If you are interested to participate as an individual person please check our list of GMP training courses and conferences.

Agenda Proposal

09.00 - 09.15

Introduction to Course and Instructor

  • Outline of the day
  • Set expectations and introduction to the trainer
09.15 - 10.15 Why is Data Integrity Important?
  • Able Laboratories fraud case 2005
  • Rewriting Compliance Program Guide 7346.832 for Pre-Approval Inspections
  • US and EU: Complete data and raw data requirements
  • Data Integrity Training for FDA Inspectors: summary of the training
  • Inspection of computerised systems is changing: paper to on-line
  • Summary of recent company warning letters dealing with data integrity
  • MHRA approach to data integrity and internal audits
  • GAMP SIG for data integrity
  • The need for a data integrity plan
10.15 - 10.45 Role of Management in Data Integrity
  • Role of Senior and Laboratory Management in ensuring data integrity or promoting data falsification and fraud
  • Failures to address poor data integrity practices and no training
10.45 - 11.00 Break
11.00 - 11.45 Principles of Data Integrity
  • The ALCOA+ criteria for data integrity
  • Paper versus hybrid versus electronic systems
  • Scope: production information versus laboratory data: why are laboratory data higher risk?
11.45 - 12.30 US 21 CFR 211 and EU GMP Chapter 4: Complete data v raw data
  • Why complete data and raw data are important for understanding data integrity
  • EU GMP Chapter 4 requirements for raw data
  • 21 CFR 211 requirements for laboratory records: complete data
  • FDA Level 2 guidance: paper versus e-records
  • Complete data / raw data example for a CDS
12.30 - 13.30 Lunch
13.30 - 14.15 Ten Compliance Commandments for Laboratory Systems
  • Outline of the 10 key areas for data integrity
14.15 - 15.30 Facilitated Discussion / Workshop on Key Data Integrity Topics
  • Recording results on paper
  • Configuration of software applications
  • Unique user identities for all users
  • Unauthorised access
  • Appropriate access privileges for each user role
  • Is my chromatographic system ready? Role of “test” injections
  • Audit trails – options for older systems
  • Standalone versus network systems
  • Protecting electronic records of standalone systems
15.30 - 15.45 Break (may be taken earlier with the long data integrity topics discussion)
15.45 - 16.45 Workshop: Developing a Data Integrity Plan
  • Key requirements for a data integrity plan and procedure
  • Prioritise systems: select one or two systems to take through process
  • Remediate, retire or replace?
  • Resources and management backing
16.45 - 17.15 Key Learning Points and Final Discussion
  • Summary of Data Integrity Requirements
  • Final Discussions

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