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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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2010
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Commissioning and Qualification - ASTM E2500-07 : life cycle, pre-requisite, Good Practices
ISPE France, Conference, Paris
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Change management by computerized systems
- Risk-based assessment of changes
- Special cases: Patches, hot fixes, virus scanner
- Data management
Concept Heidelberg, Training, Heidelberg
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Business continuity
ISPE, Conference "GAMP® 5 Operational Aspects", Washington DC
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Design Review: from milestone to process
Concept Heidelberg, Conference, Berlin
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Efficiency improvement based on virtualization
Concept Heidelberg, Workshop, Berlin
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Elaborating good requirements
Concept Heidelberg, Training, Mannheim
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2009
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IT Infrastructure Control and Compliance according to GAMP® 5
joint webinar with Jerry Hare, Talecris Biotherapeutics / Voice of Compliance,
ISPE, Webinar
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GAMP® 5: a risk-based compliance standard for computerized systems
IIR Austria, Conference, Vienna
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Quality Risk Management
IIR Austria, Conference, Vienna
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Optimal preparation of audits: for auditors and auditees
in collaboration with Lydia Dolezel, Lilly Austria
IIR Austria, Training, Vienna
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Change management by computerized systems
- Risk-based assessment of changes
- Special cases : Patches, hot fixes, virus scanner
- Data management
Concept Heidelberg, Training, Mannheim
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Business Continuity
ISPE, Conference "GAMP® 5 Operational Aspects", Strasbourg
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Practical approach to a risk-based customer/supplier relationship
ISPE France, Conference, Lyon
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>Leveraging supplier involvement
in collaboration with Dr. Arno Terhechte, GMP Inspector, Bezirksregierung Münster, Germany
Concept Heidelberg, Conference, Mannheim
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Elaborating good requirements
Concept Heidelberg, Training, Mannheim
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2008
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Quality new paradigm: outcome of ICH Q8, Q9 and Q10
on behalf of Jean-Louis Robert
ISPE France, PQLI: Product Quality Life cycle Implementation conference, Paris
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Data management: definition and principles
Concept Heidelberg, Training, Heidelberg
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Data management: from backup to data security
Concept Heidelberg, Training, Heidelberg
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Leveraging supplier involvement
IIR Germany, Technical conference, Mannheim
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GAMP® 5 principles for GxP compliant systems
Using GAMP® 5 for medical devices
MedConf 2008, Conference about embedded software for medical devices, Munich
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GxP compliant IT infrastructure for GxP compliant systems and software
Compliance requirements to the IT infrastructure for the development of medical devices
MedConf 2008, Conference about embedded software for medical devices, Munich
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Applying a risk-based approach to compliant ERP systems
Leveraging supplier involvement
ISPE, GAMP® 5 conference, Manchester
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ICH Q9, ASTM E2500-07, GAMP® 5 : Compliance strategy for computerized systems implementing a science-based risk management
ISPE France, GAMP® 5 launch conference, Lyon
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Elaborating good requirements
Concept Heidelberg, Training, Heidelberg
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PAT: Which requirements to the automated systems?
Concept Heidelberg, Conference, Mannheim
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Supplier audit: How to prepare and to behave ?
Concept Heidelberg, Post-conference workshop, Mannheim
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Inspector's expectations regarding supplier auditing
Concept Heidelberg, Post-conference workshop, Mannheim
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Supplier audit: Expectations regarding supplier's test documentation
Concept Heidelberg, Post-conference workshop, Mannheim
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ICH Q9, ASTM E2500-07, GAMP® 5 : A framework for a science-based risk management
Elan Software Systems, XFP user club 2008, Dublin
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How to evaluate and to define the testing effort? User/supplier responsibilities, risk management
GAMP Francophone, 4th Round Table, Paris
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2007
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IT Infrastructure and GAMP® 5
Concept Heidelberg, Conference, Heidelberg
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Virtualization: introduction and overview
Concept Heidelberg, Conference, Heidelberg
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Virtualization in GxP environment
Concept Heidelberg, Post-conference workshop, Heidelberg
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Good Automation Practice for HVAC: Requirements, Architecture, Qualification
ISPE, Winter Conference, Amsterdam
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Data management: definition and principles
Concept Heidelberg, Training, Heidelberg
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Data management: from backup to data security
Concept Heidelberg, Training, Heidelberg
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Audit and inspection: how to prepare, to plan, to perform and to behave?
Customer event, Germany
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Elaborating Good Requirements
Concept Heidelberg, Training, Mannheim
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2006
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Traceability in the pharmaceutical industry: Electronic Batch Record, implementing an MES, ...
Customer event, Lisbon
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ISA-88, ISA-95, GAMP® : Which framework for pharmaceutical MES projects?
ISPE France, Conference "Manufacturing Traceability", Bolbec
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Practical Case Study: MES, ERP, and Automation Systems: Functionality and Objectives
ISPE, Autumn Conference, Vienna
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Introduction to the GAMP® Good Practice Guide: 'IT Infrastructure Compliance and Control'
AKQIT, Round Table, Basle
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How automation systems fit the Commissioning and Qualification Model:
Integrating concepts of GAMP® 4 and 'Commissioning and Qualification' Baseline® Guide
on behalf of Guy Wingate
ISPE, Spring Conference, Copenhagen
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PAT: Which requirements to the automated systems?
ISPE France Affiliate, PAT Conference, Paris
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Elaborating Good Requirements
European Compliance Academy, Training, Copenhagen
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Scalability of equipment qualification: an experience report
European Compliance Academy, Conference "Regulatory requirements on laboratory computers and records", Copenhagen
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Network Qualification Principles
European Compliance Academy, IT Infrastructure Conference, Copenhagen
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Time synchronization / time management in network
European Compliance Academy, IT Infrastructure Conference, Copenhagen
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Regulatory Compliance and Process Safety in the Pharmaceutical Industry
Conference ERTS 2006, Toulouse
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Maintenance of automated systems and GAMP® 4
Conference Maintenance and Quality, organized by the department GIM (Génie Industriel et Maintenance), University Institute of Technology, Chartres
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2005
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Network Qualification, Network Management
ISPE, Winter Conference, Milano
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Introduction to the Good Process Record Management (GxP)
Pharm+Cosmetics
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GAMP® 4: Yesterday, Today, Tomorrow: history and development of the GAMP® initiative
ISPE France, GAMP® Conference, Toulouse
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Validation of Laboratory Computer Systems
ISPE France, GAMP® Conference, Toulouse
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IT Network Qualification
Concept Heidelberg, CSV Conference, Mannheim
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Time synchronization / time management in network
Concept Heidelberg, CSV Conference, Mannheim
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GxP compliant data management
Benediktbeurer Reinraumtage 2005
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2004
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Risk-based planning, execution and qualification
Customer event, Stuttgart
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Risk-based planning and execution:
Equipment Qualification, Process Validation
Benediktbeurer Reinraumtage
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2003
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Automation and Risk Evaluation
ISPE France Affiliate, Conference, Paris
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Risk-based approach to cGxP: New 21CFR11 Guidance for Industry (FDA)
Customer event, Interlaken
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Quality oriented clean-room monitoring
Benediktbeurer Reinraumtage
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