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Presentations
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This is a list of some presentations performed during the mentioned events:
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2017
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Data Integrity Master Class
(in collaboration with Karl-Heinz Menges, Arno Terhechte, Wolfgang Schumacher, and Robert (Bob) McDowall)
- Data flow analysis
- Workshop: Data flow analysis
- Time synchronisation
- QA oversight for data integrity
- Workshop: QA oversight for data integrity
- Cybersecurity and data integrity
- Data governance
- Data integrity audit results of a contract laboratory
- Case study: data migration - Manufacturing
- Key learning points
ECA - European Compliance Academy, Training, Berlin
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Data integrity
(in collaboration with Karl-Heinz Menges / Christa Färber / Arno Terhechte, and Robert (Bob) McDowall)
- Why is data integrity important? Setting the scene
- Principles of data integrity
- Role of management in data integrity
- Workshop: Analysis of an FDA warning letter
- User account management and application configuration
- IT support for data integrity
- Facilitated discussion / workshop on key data integrity issues
- Workshop: Assessing a system for data integrity
- Supply chain integrity: organisational interfaces
- Key learning points
ECA - European Compliance Academy, Training, Copenhagen
ECA - European Compliance Academy, Training, Budapest
ECA - European Compliance Academy, Training, Copenhagen
ECA - European Compliance Academy, Training, Berlin
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Raw Data
(in collaboration with Robert (Bob) McDowall)
- Data, Information and Knowledge
- Interpretation of Raw Data for Production Systems
ECA - European Compliance Academy, Training, Berlin
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Audit trail review
(in collaboration with Robert (Bob) McDowall)
- Audit trail vs system log
- Requirements for the audit trails - Technical controls to aid second person review of audit trails
ECA - European Compliance Academy, Training, Berlin
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Data integrity manager
- Data flows
- Data integrity and system suppliers
- Data integrity audits
- Role of management in data integrity
- Data integrity training
- Organisational interfaces and outsourcing
Concept Heidelberg, Training, Mannheim
Concept Heidelberg, Training, Darmstadt
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Audit Trail and Audit Trail Review
- Purpose and objectives of audit trails (review)
- Audit trail vs system log
- Requirements for the audit trails: Technical controls to aid second person review of audit trails
- Workshop: Elaborating audit trail requirements
Concept Heidelberg, Training, Mannheim
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Integrity of laboratory data
(in collaboration with Arno Terhechte and Markus Zeitz)
- What data are important ?
- Principles of data integrity
- Workshop: Analysis of FDA Warning Letters
- SLA and data integrity: organisational interfaces
- Audit trails to support data integrity
- Workshop: Elaboration of a data integrity strategy
- The 12 tasks of the data integrity
Concept Heidelberg, Training, Karlsruhe
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IT for non-IT personal
(in collaboration with Klaus Feuerhelm and Hartmut Hensel)
- Hardware and software technologies
- IT landscape within an industrial environment
- Data management
- Life cycle of computerised systems and software
- CSV Requirements
- IT-Trends - Opportunities / Limits / Threats
Concept Heidelberg, Training, Heidelberg
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e-Compliance Manager training
- CSV life cycle
- System classification according to the GAMP software categories
- Requirements, specifications, and life cycle
- Guidelines for preparing specifications
- Needs and requirements capture
- Case study: requirement quality
Concept Heidelberg, Training, Heidelberg
Concept Heidelberg, Training, Heidelberg
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Computer Validation: Maintaining Control of Operation (MCO)
(on behalf of David Selby, in collaboration with Robert (Rob) Stephenson and Frank Behnisch)
ECA - European Compliance Academy, Training, Barcelona
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Cloud Computing in regulated GxP environment
(in collaboration with Arno Terhechte and Michael Wegmann)
- Workshop: Cloud controls? What, how, how much, who?
- Workshop : Findings and assessments
- Compliance requirements to virtualised IT infrastructure
Concept Heidelberg, Training, Mannheim
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Virtualised IT systems in GMP environment: Qualification and Operation
(in collaboration with Eberhard Kwiatkowski)
- Introduction and definitions
- Regulatory requirements, responsibilities, use cases
- Planning of virtualisation projects
- Qualification of virtualisation platform
- Workshop : Change management
- Life cycle, change management
- Risk management
- Workshop : Risk-based approach to planning of virtualisation project
- From virtualisation to Cloud Computing
Concept Heidelberg, Training, Mannheim
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Change management by computerised systems
(in collaboration with Klaus Feuerhelm, Eberhard Kwiatkowski and Uwe mai)
- Risk-based assessment of changes
- Special cases: Patches, hot fixes, virus scanner
- Data management
Concept Heidelberg, Training, Mannheim
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Virtualised IT systems in GMP environment: Qualification and Operation
(in collaboration with Robert (Bob) McDowall and Jürgen Schmitz)
- Planning of virtualisation projects
- Virtualisation platform: Overview
- Planning of virtualisation platform projects
- Workshop: Qualification documentation
- Risk management
- Workshop: Risk-based approach to planning of virtualisation platform
- From virtualisation to Cloud Computing
ECA - European Compliance Academy, Training, Copenhagen
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Pharma IT Conference 2017
- Data Integrity findings during FDA inspections
- Specifying Data Integrity requirements: proposal
Concept Heidelberg, Conference, Mannheim
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Pharma Congress 2017 - Automation
- Integrity of manufacturing data
Concept Heidelberg, Conference, Düsseldorf
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ISPE France / GAMP® Francophone Conference 2017
Data integrity: from theory to practice
- Conference opening
- Current situation and regulatory pressure
- Data integrity begins at URS
ISPE France, Conference, Suresnes
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10th GAMP® 5 Conference
- IT Infrastructure Control and Compliance
- Global Information Systems Control and Compliance
Concept Heidelberg, ISPE D-A-CH, APV, VDI/VDE, Conference, Mannheim
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BioMérieux Industry Spain: X Pharma Symposium
Data integrity for the pharmaceutical microbiology laboratory
- Introduction to Data Integrity
- User account management and application configuration
- Data integrity and audit trails
- Analysis of FDA warning letters: Laboratory weaknesses
- Key learning points: The twelve data integrity tasks
BioMérieux Industry Spain
- User conference, Madrid
- User conference, Barcelona
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