Post Learning Implementation Plan (PLIP)

Pre-course

• Access to the Educo Training Portal
• Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

• At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

• Delivered 3 to 4 weeks after the training
• It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges

Day 1

Historical background and data integrity definitions

• Data integrity and patient safety/product efficacy
• The evolution of GxP regulations – driven by both criminal activity and honest mistakes
• The US FDA’s debarment policy
• Evolution of data integrity guidances
• Introduction to GAMP 5
• Early data integrity cases

 

Regulatory expectations

• ALCOA and ALCOA+
• Static and dynamic records
• Essential elements of data governance
• Non-conformance trends
• Data integrity controls
• Data integrity risks in sample analysis and production
• Investigating data integrity problems
• Metadata, audit trails and audit trail review

 

Data integrity risk assessment

• Quality risk management: ICH Q9
• Risk management process
• Approaching a data integrity risk assessment
• Controlling risk in computerised systems
• Configuration and life cycle management
• Operating system and application software considerations

 

Computerised systems

• Audit trails, access controls and user permissions
• Excel spreadsheets – practical advice on the appropriate use, validation and control of Excel spreadsheets
• Introduction to computerised data system validation

 

Extracts from regulatory enforcement letters

 

Addressing data integrity problems

 

Day 2

Managing computerised data systems

• Guidance
  • 21 CFR Part 11
  • EU Annex 11
  • GAMP 5
• Examine the detailed practices recommended by GAMP 5
• Life cycle management and risk assessment
• Supplier assessment

 

Computerised system validation

• Validation planning
  • Policy
  • Plans
  • Documentation
• System description
• Introduction to software testing

 

Conducting a data integrity audit

• Planning the audit
• Conducting the audit
  • Policies, procedures, practices
  • Training
  • Quality culture
• Evaluating quality risk
• Mitigating data integrity risks

 

Managing client audits and regulatory inspections

• The importance of data integrity risk assessments/action plans
• The audit/inspection process
• Client audits
  • Confidentiality
  • Result checking and reporting
• Regulatory inspections
  • Behaviour during inspection
  • Responding to non-conformance observations

Dr. Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over 30 years’ experience as an analytical chemist. In 2003, he helped to set up a UK-based contract research and manufacturing company specialising in early-stage drug development, where he ran the analytical development programme. His responsibilities included commissioning and validating laboratory data systems and training staff.

 

In 2013, he set up his own company which offers training and consultancy services to the pharmaceutical industry. These include guiding the CMC aspects of drug development programmes and training in areas such as chromatography, dissolution testing, data integrity, method development/validation, analytical instrument qualification, technical writing and auditing.

 

Mark has delivered numerous training courses on data integrity, helping professionals and organisations to understand the latest guidances and implement best practice. He provides expert advice in all areas of data integrity such as regulatory guidances, audits, GAMP 5 and risk assessments. He has conducted data integrity audits in the UK, continental Europe and the United States. Mark draws on his extensive experience and provides multiple examples throughout the course. He has recently co-authored a data integrity guide in collaboration with the laboratory supplier and instrument manufacturer VWR.