Wednesday, 30 August 2023
Regulatory Update
- EU GMP Requirements
- Guidance Documents Overview (state of the art)
- “These Guides are not intended to impose additional regulatory burden upon regulated entities”. Is this correct?
- Data Governance, Dynamic Data
Quality Culture for Data Integrity
- Regulatory expectations for a data integrity quality culture
- Role senior management in creating the culture
- Components of a quality culture
- Reinforcement of the culture
Data Flow Analysis
- Objective and purpose
- Electronic data flow
- Complete data flow
- Identification of possible weaknesses
Workshop on Data Flow Analysis
Metrics for Data Integrity
- Metrics in the context of a corporate data integrity programme
- Suggested metrics in the assessment phase
- Suggested metrics in the operational phase
QA Oversight for Data Integrity
- Data integrity training
- Enforce data flows
- Reviews
- Internal inspection
- Audit of external organisations
Workshop on QA Oversight for Data Integrity
Control of Master Templates and Blank Forms
- Why is control of master templates and blank forms important?
- Regulatory requirements from FDA, MHRA, WHO, EMA and PIC/S
- Devising and controlling the master template
- Operational use of the blank forms
- Do you really want to work this way?
Data Integrity in the Pharmaceutical Quality System / Data Governance
- Which PQS elements need to be added or updated?
- The Data Integrity Program
- Priorities (immediate/short/mid-term)
- Capacity, Timing
- Governance responsibilities
- Data governance vs. IT governance
- Elements of a data governance
- Embedding data governance into the PQS
Thursday, 1 September 2023
Audit Trail Review
- Regulatory Overview
- Essential Audit Trails in QA/QC/Manufacturing
- Risk-based Approach
- What about legacy systems w/o Audit Trail?
- Who shall review Audit Trails? Documentation
- What process and documentation is appropriate in case of deviations/discrepancies?
Second Person Review
- Regulatory and guidance document requirements for the second person review
- Role of the second person Review
- Scope of the second person Review
- Documenting the review for paper, hybrid and electronic systems
- Facilitated discussion on Second Person review
Facilitated Discussion on Second Person Review
Preparing your Company for an Data Integrity Inspection
- How to present the DI status and future approach?
- Gap analysis
- Training program coverage
- Experience from FDA inspections – Hot Buttons
DI Inspections
- Basis for Inspections: “PIC/S Good Practices for Data Management and Integrity in regulated GMP/GDP Environments”
- Data Integrity Assessment during Inspection
- Quality Control, Manufacturing
- Inspection Findings
Workshop: Data Inspection Findings
Vulnerability of Records
- What is record vulnerability?
- Protection and security of electronic records requirements
- What can go wrong? Scope of misfortunes that can impact records
- Assessment of record vulnerability and implementation of control measures
Workshop on Vulnerability of Records
Case Study Data Migration: Preserving Content and Meaning
- Principles of data migration
- Design of the migration process
- Risk-based elaboration of the verification strategy – case study examples
Friday, 2 September 2023
Cybersecurity / Cloud Computing / Time Synchronisation
- Cybersecurity securing data integrity
- Robust IT infrastructure
- Time Synchronisation
- Qualification of time dissemination
Results of a Data integrity Audit from a Contract Laboratory
- Audit context, Audit scope, Findings, Root causes
Data Integrity Investigations
- What are data integrity investigations?
- Human and technical triggers for DI investigations
- Who should investigate the problem?
- Process description and how to document a DI Investigation
- Should we inform regulatory authorities?
Workshop on Data Integrity Investigations
Options for Long Term Data Retention
- Proprietary v open standards for laboratory data
- Options for long term retention:
- Keep original system, Virtualisation, Data migration
Workshop: Justifying Long Term Solutions
Key Learning Points and Final Discussion