Pre-course session "Raw Data - Understanding, Defining and Managing"
Tuesday, 15 June 2021
Data, Information and Knowledge
An overview presentation covering for production, laboratories and QA. Link to regulations e.g,
- Data vs information vs knowledge
- From knowledge to insight
- DIKI model
- Product, Prcocess, Data
- US GMP regulations: 211.68(b), 211.180(d), 211.188 and 211.194(a-e): complete data and complete information
- EU GMP Chapter 4 regulations – raw data principles outlined from a GMP perspectiv
Cutting Through the Confusion and Fog of Regulatory Terms
Currently there are many terms used in GMP regulations and data integrity guidance documents. What do they mean? How are they relevant to debate? Definition and interpretation of
- Original record / record
- Raw data – MHRA GMP and US GLP definitions
- Data and metadata
- True copy
- Complete data
- Initial data
- Translating raw data for a GMP environment: should we treat manufacturing and laboratory the same when it comes to raw data?
Interpretation of Raw Data for Production Systems
Using a manufacturing process that is automated by standalone PLCs, PLCs linked to a SCADA system and an automated Manufacturing Execution System, what constitutes raw data will be outlined.
- Raw Data for PLCs
- PLCs linked to a SCADA system
- SCADA linked to a Manufacturing Execution System
Interpretation of Raw Data for Laboratory Systems
Using a process involving a chromatography data system and a LIMS, what constitutes raw data will be outlined in two scenarios
- Hybrid CDS and manual input to the LIMS
- Electronic CDS with automatic transfer to the LIMS
- Managing sample management and preparation records
Case Study/Workshop: Defining Raw Data for Production, QA and Laboratory Systems
Can a True Copy be Raw Data?
This brief presentation will start from the definitions of raw data and true copy and explore if and how a true copy can be considered raw data.
Case Study/Workshop : What are Raw Data for quality decisions
Data Integrity Master Class
Wednesday, 16 June 2021
- 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
Case Study/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
- Internal inspection
- Audit of external organisations
Case Study/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, 17 June 2021
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?
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
- 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
Case Study/Workshop: Data Inspection Findings
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
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
Case Study/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, 18 June 2021
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?
Case Study/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
Case Study/Workshop: Justifying Long Term Solutions
Key Learning Points and Final Discussion