This is a list of some presentations performed during the mentioned events:

• Planning for success : The project "big picture"
  ISPE, Conference "Cost-effective Compliance: Practical Solutions for Computerised Systems", Brussels
• Training (in collaboration with David Stokes, Business&Decision)
  - Regulatory inspections
  - Supplier and Service Provider Auditing according to Annex 11
  IIR Austria, Training, Vienna
• Computerized System Validation according to Annex 11
  - New Annex 11 - Background and regulatory requirements
  - Implementing Annex 11 and consequences
  - Impacts of Annex 11 on the validation activities
  - Maintaining the compliance state - Periodic Evaluation
  IIR Austria, Conference, Vienna
• Annex 11, version 2011 - Operational Phase: Chapters 14 - 17
  joint presentation with Klaus Eichmüller, ZAB / Regierung von Oberbayern, Germany
  Concept Heidelberg, Conference, Mannheim
• (e)Compliant Supply Chain
  From ingredient and excipient manufacturing to patient delivery
  ISPE, Conference "Supply Chain Integration to Maximise Profit and Compliance", Frankfurt am Main
• eCompliance 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
  - Elaboration process for requirement and specification
  Concept Heidelberg, Training, Heidelberg

• Commissioning and Qualification - ASTM E2500-07 : life cycle, pre-requisite, Good Practices
  ISPE France, Conference, Paris
• Change management by computerized systems
  - Risk-based assessment of changes
  - Special cases : Patches, hot fixes, virus scanner
  - Data management
  Concept Heidelberg, Training, Heidelberg
• Business continuity
  ISPE, Conference "GAMP® 5 Operational Aspects", Washington DC
• Design Review: from milestone to process
  Concept Heidelberg, Conference, Berlin
• Efficiency improvement based on virtualization
  Concept Heidelberg, Workshop, Berlin
• Elaborating good requirements
  Concept Heidelberg, Training, Mannheim

• IT Infrastructure Control and Compliance according to GAMP® 5
  in collaboration with Jerry Hare, Talecris Biotherapeutics / Voice of Compliance,
  ISPE, Webinar
• GAMP® 5: a risk-based compliance standard for computerized systems
  IIR Austria, Conference, Vienna
• Quality Risk Management
  IIR Austria, Conference, Vienna
• Optimal preparation of audits: for auditors and auditees
  in collaboration with Lydia Dolezel, Lilly Austria
  IIR Austria, Training, Vienna
• Change management by computerized systems
  - Risk-based assessment of changes
  - Special cases : Patches, hot fixes, virus scanner
  - Data management
  Concept Heidelberg, Training, Mannheim
• Business Continuity
  ISPE, Conference "GAMP® 5 Operational Aspects", Strasbourg
• Practical approach to a risk-based customer/supplier relationship
  ISPE France, Conference, Lyon
• >Leveraging supplier involvement
  in collaboration with Dr. Arno Terhechte, Bezirksregierung Münster
  Concept Heidelberg, Conference, Mannheim
• Elaborating good requirements
  Concept Heidelberg, Training, Mannheim

• 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
• Data management: definition and principles
  Concept Heidelberg, Training, Heidelberg
• Data management: from backup to data security
  Concept Heidelberg, Training, Heidelberg
• Leveraging supplier involvement
  IIR Germany, Technical conference, Mannheim
• GAMP® 5 principles for GxP compliant systems
  Using GAMP® 5 for medical devices
  MedConf 2008, Conference about embedded software for medical devices, Munich
• 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
• Applying a risk-based approach to compliant ERP systems
  Leveraging supplier involvement
  ISPE, GAMP® 5 conference, Manchester
• 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
• Elaborating good requirements
  Concept Heidelberg, Training, Heidelberg
• PAT: Which requirements to the automated systems?
  Concept Heidelberg, Conference, Mannheim
• Supplier audit: How to prepare and to behave ?
  Concept Heidelberg, Post-conference workshop, Mannheim
• Inspector's expectations regarding supplier auditing
  Concept Heidelberg, Post-conference workshop, Mannheim
• Supplier audit: Expectations regarding supplier's test documentation
  Concept Heidelberg, Post-conference workshop, Mannheim
• ICH Q9, ASTM E2500-07, GAMP® 5 : A framework for a science-based risk management
  Elan Software Systems, XFP user club 2008, Dublin
• How to evaluate and to define the testing effort? User/supplier responsibilities, risk management
  GAMP Francophone, 4th Round Table, Paris

• IT Infrastructure and GAMP® 5
  Concept Heidelberg, Conference, Heidelberg
• Virtualization: introduction and overview
  Concept Heidelberg, Conference, Heidelberg
• Virtualization in GxP environment
  Concept Heidelberg, Post-conference workshop, Heidelberg
• Good Automation Practice for HVAC: Requirements, Architecture, Qualification
  ISPE, Winter Conference, Amsterdam
• Data management: definition and principles
  Concept Heidelberg, Training, Heidelberg
• Data management: from backup to data security
  Concept Heidelberg, Training, Heidelberg
• Audit and inspection: how to prepare, to plan, to perform and to behave?
  Customer event, Germany
• Elaborating Good Requirements
  Concept Heidelberg, Training, Mannheim

• Traceability in the pharmaceutical industry: Electronic Batch Record, implementing an MES, ...
  Customer event, Lisbon
• ISA-88, ISA-95, GAMP® : Which framework for pharmaceutical MES projects?
  ISPE France, Conference "Manufacturing Traceability", Bolbec
• Practical Case Study: MES, ERP, and Automation Systems: Functionality and Objectives
  ISPE, Autumn Conference, Vienna
• Introduction to the GAMP® Good Practice Guide: 'IT Infrastructure Compliance and Control'
  AKQIT, Round Table, Basle
• 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
• PAT: Which requirements to the automated systems?
  ISPE France Affiliate, PAT Conference, Paris
• Elaborating Good Requirements
  European Compliance Academy, Training, Copenhagen
• Scalability of equipment qualification: an experience report
  European Compliance Academy, Conference "Regulatory requirements on laboratory computers and records", Copenhagen
• Network Qualification Principles
  European Compliance Academy, IT Infrastructure Conference, Copenhagen
• Time synchronization / time management in network
  European Compliance Academy, IT Infrastructure Conference, Copenhagen
• Regulatory Compliance and Process Safety in the Pharmaceutical Industry
  Conference ERTS 2006, Toulouse
• 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

• Network Qualification, Network Management
  ISPE, Winter Conference, Milano
• Introduction to the Good Process Record Management (GxP)
  Pharm+Cosmetics
• GAMP® 4: Yesterday, Today, Tomorrow: history and development of the GAMP® initiative
  ISPE France, GAMP® Conference, Toulouse
• Validation of Laboratory Computer Systems
  ISPE France, GAMP® Conference, Toulouse
• IT Network Qualification
  Concept Heidelberg, CSV Conference, Mannheim
• Time synchronization / time management in network
  Concept Heidelberg, CSV Conference, Mannheim
• GxP compliant data management
  Benediktbeurer Reinraumtage 2005

• Risk-based planning, execution and qualification
  Customer event, Stuttgart
• Risk-based planning and execution:
  Equipment Qualification, Process Validation
  Benediktbeurer Reinraumtage

• Automation and Risk Evaluation
  ISPE France Affiliate, Conference, Paris
• Risk-based approach to cGxP: New 21CFR11 Guidance for Industry (FDA)
  Customer event, Interlaken
• Quality oriented clean-room monitoring
  Benediktbeurer Reinraumtage

Information