Speakers
Bob McDowall, R.D.McDowall Ltd.
Yves Samson, Kereon AG
Dr Wolfgang Schumacher, formerly F. Hoffmann-La Roche Ltd.
Dr Arno Terhechte, Bezirksregierung Münster
Programme
Data Integrity Master Class
Regulatory Update
- EU GMP Requirements: Chapter 4, Annex 11
- Guidance Documents Overview (state of the art): GMDP Inspectors WG, Data Integrity Q&A, (PIC/S Good Practices for Data Management and Integrity in regulated GMP/GDP Environments), WHO, Annex 5 Guidance on Good Data and Record Management Practices, MHRA GxP Data Integrity Definitions and Guidance for Industry
- FDA, Data Integrity and Compliance with cGMP
- “These Guides are not intended to impose additional regulatory burden upon regulated entities”. Is This correct?: Data Governance, Dynamic Data
- Which PQS elements need to be added or updated?
- The Data Integrity Program: Priorities (immediate/short/mid-term), Capacity, Timing
- GMP requirements for good documentation practice
- Application to paper documents
- Common problems from FDA 483 observations and warning letters and how to avoid them
- Objective and purpose
- Electronic data flow
- Complete data flow
- Identification of possible weaknesses
- Metrics in the context of a corporate data integrity programme
- Suggested metrics in the assessment phase
- Suggested metrics in the operational phase
- 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
- 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
- Purpose and requirements
- TAI, UTC, time zone, legal time, local time, system time
- ntp - network time protocol
- Time management concept
- Regulatory requirements for software systems:
- procedural and technical
- Role of software suppliers
- Regulations push vs market needs pull
- Implementing technical requirements for software: architecture, database and application
- Marketing literature versus marketing bullshit
- 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?
- Regulatory requirements and expectations for audit trail review
- Is the application adequate for audit trail review?
- Application of a risk based approach to audit trail 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
QA oversight for data integrity
- Data integrity training
- Enforce data flows
- Reviews
- Internal inspection
- Audit of external organisations
Cyber security measures to assure data integrity
- Cyber security reality and concerns
- Possible security weaknesses
- Designing robust IT and automation infrastructures
- Governance responsibilities
- Data governance vs. IT governance
- Elements of a data governance
- Embedding data governance into the PQS
- Audit context
- Audit scope
- Findings
- Root causes
- Migration of complex data collections
- Migration of a large collection of similar data
- Design of the migration process
- Risk-based elaboration of the verification strategy
- Proprietary v open standards for laboratory data
- Options for long term retention:
- Keep original system
- Virtualisation
- Data migration
- 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?
Key Learning Points and Final Discussion
Audit Trail Review
Why Is An Audit Trail and Its Review Important?
- Part 11 and Annex 11 / Chapter 4 requirements for audit trail
- Regulatory requirements for audit trail review
- Guidance documents for audit trail review
- Do I really need an audit trail?
- What do we look for in an application for auditing?
- Pros and cons for event logs and audit logs?
- Which audit trail(s) should I review?
What are GMP-Relevant Data?
- Annex 11 requires that audit trails monitor GMP-relevant data – what are GMP relevant data?
Review of Audit Trail Entries
- Guidance for frequent is “frequent review” of audit trails
- Process versus system: avoiding missing data integrity issues when only focussing on a per system review
- What are we looking for in an audit review?
- Suspected data integrity violation - What do we need to do?
Technical Controls to Aid Second Person Review of Audit Trails
- Technical considerations for audit trail review e.g.
- Identifying data that has been changed or modified – how the system can help
- Documenting the audit trail review has occurred
- Review by exception – how technical controls can help
- Have you specified and validated these functions?
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