Winter Conference

Transcription

Winter Conference

ISPE Milan Conferences
UPDATED
PROGRAMME
Marriott Hotel • Milan, Italy
28 November > 01 December 2005
28-29 November
• Containment Technology Forum
• Sterile Product Processing for the 21st Century - Innovations, Guidelines and
Regulatory Expectations
• Update on the Draft ISPE Maintenance Baseline® Guide and Current
Maintenance Approaches in Industry ST
30 November
• Infrastructure: Validation, Compliance and Control in a Global IT Environment
ST
30 November - 01 December
• Cleaning and Cleaning Validation
• Risk Management and ICHQ9
01 December
• Global Information Systems: Validation, Compliance and Control in a Global IT
Environment ST
The Conferences will also include a Social Evening organised by the ISPE Italy
Affiliate, two networking receptions, and a Table Top exhibition.
www.ispe.org/GoTo_MilanConferences
Stay
up-to-date on
the latest
developments
in the
pharmaceutical
industry.
Join us in Milan!
ST
Indicates that simultaneous translation (English-Italian) is available.
Indica che la traduzione simultanea (inglese-italiano) è disponibile.
About the Event
The ISPE Milan Conferences are part of the 2005 ISPE Continuous
Advancement Programme. The event includes:
• Seven Conferences on the pharmaceutical industry trends and challenges
• More than 90 speakers
• Programme at-a-Glance
3
• A Table Top Exhibition including around 30 different companies
• Programme
4-17
• General Information
18
• Networking Opportunities
19
• Table Top and Sponsorship Opportunities
20
• Registration and Cancellation Policies
21
• Registration Form
22
• Two Networking Receptions
• ISPE Italy Affiliate Social Evening
Over 350 attendees are expected!
Platinum Sponsors
Join us in Milan,
Register today!
Silver Sponsors
Simultaneous translation
ST
is sponsored by
Engineering Pharmaceutical Innovation
Programme at-a-Glance
Monday, 28 November
Tuesday, 29 November
Thursday, 1 December
Wednesday, 30 November
Containment Technology Forum
Sterile Product Processing for the 21st Century - Innovations,
Guidelines and Regulatory Expectations
Update on the Draft ISPE Maintenance Baseline® Guide
and Current Maintenance Approaches in Industry ST
Infrastructure: Validation,
Compliance and Control in a
Global IT Environment ST
Cleaning and Cleaning Validation
Risk Management and ICHQ9
Global Information Systems:
Validation, Compliance and
Control in a Global IT
Environment ST
Table Top Exhibition
Networking Reception
Networking Reception
Italy Affiliate Social Evening
For conference descriptions, go to pages 4-17
ST
Indicates that simultaneous translation (English-Italian) is available.
Indica che la traduzione simultanea (inglese-italiano) è disponibile.
Global On-line Career Centre for the Pharmaceutical Industry
Looking for an exciting new job? Interested in reaching the most qualified candidates? Make your search
fast, easy, targeted and successful. The ISPE Global On-line Career Centre, at www.ispe.org, is available
to better serve the needs of both employers and job seekers around the world.
Searching For an Employee?
ISPE’s Global On-line Career Centre gives employers access to an extensive on-line database of curriculum
vitaes (CVs), entry to a targeted group of pharmaceutical manufacturing professionals and the ability to
conduct searches by country as well as worldwide. Finding your next employee is just a mouse-click away.
Looking For a Job?
Get your job search started by using ISPE’s complimentary Global On-line Career Centre. Apply directly to
a prospective employer and if you are an ISPE Member, post your CV as well at no charge.
For more information on the ISPE Global On-line Career Centre, contact Kristien Bossuyt by
e-mail: [email protected], tel: + 32-2-743-4422, or visit www.ispe.org
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Containment Technology Forum
28-29 November 2005
Conference Leaders
Giorgio de Castiglioni, Pharmatech Srl, Italy
Johannes Rauschnabel, Robert Bosch GmbH, Germany
Conference Description
Who Should Attend
This Conference will discuss the latest developments in
the containment of potent compounds for the
manufacture of bulk active pharmaceutical ingredients
and the production of drugs in their final dosage form.
• All professionals working in the field of potent
compound containment
• Health and safety executives
• Project and production managers, operations
managers
• Quality assurance professionals and regulatory affairs
executives
The challenges of complying with health and safety
requirements, current GMP demands and new developments in engineering and methodology will all be
developed and discussed in detail.
Leading international speakers will provide a global
perspective of the regulatory expectations for
compliance with health and safety and GMP. Risk
evaluation professionals will discuss the development of
a practical and compliant risk assessment strategy.
Programme
A number of new, practical case studies will leverage
the experience of others to demonstrate the impact of
containment on the planning, designing and
construction of facilities. The successful validation of
facilities and equipment, as well as “state-of-the-art
advances” will also be featured.
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Learning Objectives
At the conclusion of this conference, delegates will be able to:
• Gain an appraisal of current HSE issues
• Learn about the regulatory expectations for
containment
• Understand the implications of containment on
facility design and operation
• Discuss with peers the impact and importance of
current state-of-the-art facility and equipment
designs
• Follow projects from conception phase to production
• Experience the interface between containment and
aseptic requirements for clinical trials
• Discuss and share experiences with fellow regulatory
and industry speakers and delegates and get your
issues addressed in a unique environment
Agenda
Monday, 28 November
10.00 - 10.15 Welcome and Introduction
10.15 - 11.15 Containment Issues from Design to
Construction
Gerald Cerulli, Technip Biopharm, USA
Jean François Dulière, Technip France, France
Francesco Zinnamosca, Technip Italy, Italy
• Regulations in Europe and USA
• Methodology, process design
• Specification and equipment
• Examples
11.15 - 12.15 Solids Containment for Filter Dryers
Torsten Belger, Powder Systems Ltd., UK
• Problem areas with HAPI filter dryers
• Solutions for today's HAPI requirements
• Practical examples
• Total containment for small scale filter dryers
12.15 - 13.45 Lunch
13.45 - 14.45 Challenges and Innovation in Glove Testing
• Glove handling in containment and GMP
• Glove requirements
• Existing testing procedures and shortcomings
• Innovative glove testing
09.00 - 09.15 Recap of Day 1 – Introduction of Day 2
15.45 - 16.15 Coffee Break
16.15 - 17.15 Regulatory Requirements Related to
Barrier Isolation Technology
Speaker to be advised
• Impact of isolators from a regulatory perspective
• Current international regulations for barrier isolation technology applied to pharmaceutical manufacturing and testing
• Common GMP issues
17.15 - 17.45 Questions and Answers Session – Chair’s
Day 1 Close
17.45 - 19.30 Networking Reception
10.45 - 11.45 Flexible Containment Systems for
Discharge and Filling
Richard Denk, Hecht Anlagenbau GmbH, Germany
• Explanation of containment solutions for bulk solids from
milligrams to nanograms
• How to reach a high containment with regular FIBC's and
drums with liner
• New state of the art discharge and filling systems in
nanogram levels
• Particle measurement in accordance with SMEPAC during FAT
• Qualification of a high containment system
11.45 - 12.45 Numeric Simulation for Air Flow
Optimisation with Containments
Alois Schälin, AFC Air Flow Consulting, Switzerland
• CFD for containment technology
• Methods/modelling
• Validation/quality assurance
• Examples from successful air flow simulation studies
12.45 - 14.15 Lunch
14.15 - 15.15 High Containment Solutions for
Compression and Tablet Handling
Harald Römer, Fette GmbH, Germany
• Downsides of conventional handling
• Key success factors for containment units
• Integral approach from powder supply to dedusted and
checked tablets
• Fette's solutions
Programme
14.45 - 15.45 Combining cGMP and PBOEL –
Regulations in API Plant Design
Geert Marien, Janssen Pharmaceutica N.V., Belgium
• cGMP area classification in API manufacturing
• Containment solutions related to PBOEL level
• Approach to combine cGMP and PBOEL regulations in
API plant design
• Two case studies: (I) API production train for PBOEL 3B
and parenteral products; (II) Powder handling unit and
warehouse design
09.15 - 10.15 Containment Update on ISPE Baseline® Guides
ISPE Representative invited
• Bulk Pharmaceutical Chemicals Baseline Guide
• Particulate measurement (SMEPAC)
Conference Close
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Sterile Product Processing for the 21 st Century 28-29 November 2005
Conference Leaders
Gordon Farquharson, Bovis Lend Lease Technology, UK
Nunzio Genoni, Jacobs Italia SpA, Italy
This conference will first explore how FDA’s Aseptic
Guidance has bedded down, how it fits with the
anticipated changes in Annex 1 (expected mid 2005)
and the possible changes to the cleanroom standard
ISO 14644-1:1999. This standard is due for systematic
review in 2005.
Programme
Speakers will flesh out some of these requirements with
presentations of case studies and operational
experience to help illustrate how the industry is
interpreting the guidance, and the real cGMP
compliance issues. Available technologies including
blow-fill-seal, RABS, isolators and particle counting will
be explored. The seminar will provide the opportunity for
discussion of some key issues influencing operations in
the field of advanced aseptic processing and the impact
on the business.
10.15 - 11.00 FDA’s Aseptic Guidance (September 2004)
– Industry View: 12 Months on
• Brief history of the development of the guidance
• Implementation as part of the “GMPs for the 21st Century”
• Implementation issues so far
11.00 - 11.45 A European Regulatory Perspective on
Sterile Product Processing
Jean-Denis Mallet, France
• Critical sterile products issues from an EU regulatory perspective
• Status of the revision to Annex 1 of the EU GMP related to
airborne particles and media fill (process simulation)
• Sterile products inspection trends
Learning Objectives
11.45 - 12.15 Regulatory Discussion
At the conclusion of this seminar, delegates will be able to:
12.15 - 13.30 Lunch
• Understand how the industry is dealing with the 2004
GMP changes
• Describe principles such as Grade A continuity
• Explain forthcoming changes to Annex 1, ISO 14644-1
and ISPE’s Sterile Manufacturing Facilities Baseline®
13.30 - 14.30 Restricted Access Barrier System (RABS) –
Presentation of ISPE / FDA Draft
Jack Lysfjord, Valicare Division, Bosch, USA
The USA FDA has become increasingly concerned that the
term RABS is being used too loosely by our industry. FDA
has sought ISPE’s support to develop a consensus about
this important advanced aseptic processing technology.
The aspects considered will be:
• What is a RABS?
• Which elements are essential to call it a RABS?
• RABS design basis
• Standard operating procedures required for rare interventions
• Initial high level disinfection with sporicidal agent
• The progress of the guidance note
Guide
• Apply state of the art environmental monitoring
• See how advanced aseptic techniques can influence
their business
Who Should Attend
• Practitioners looking for valuable insight into recent
and changing guidance and regulations
• Engineers, quality assurance, quality control and
production professionals
• Financial, operational and technical managers
• Suppliers
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Agenda
Monday, 28 November
14.30 - 15.30 Case Study: Innovative Solutions for Filling
and Freeze Drying of Biopharmaceuticals – RABS
Technology
Frank Küpler, Ferring, Germany
Freeze drying is an essential and growing technology
applied to many biological products. The product and
process is highly susceptible to contamination and the
industry is keen to find low-risk solutions.
• Automated freeze dryer loading/unloading system:
Comparison of alternatives, presentation of the selected
solutions with fully automated frame handling
• Application of RABS technology
• Environmental monitoring
Innovations, Guidelines and Regulatory Expectations
16.00 - 16.45 Operational and Business Impact when
Introducing Isolation Technology in a Manufacturing
Facility
Paul Ruffieux, Skan, Switzerland
• Basic requirements to purchase a “good” isolator
• Understanding the technology in the context of batch and
campaign planning
• Planning of all activities for an optimal start up of an isolator
- Adequate resources, training of the operators, development
of the paperwork of FAT/SAT, installation, start-up phase
• Validation programme
- Decontamination process, PQ, monitoring, etc.
• Programme and timing for all steps until start of production
• Maintenance, re-validation, re-qualification
16.45 - 17.30 Case Study: Successful Project Delivery in
Isolation Technology
Day 1 Close
09.10 - 10.00 Freeze Dryer Innovative Design for
Handling Potent Drugs and/or Packaging Components
with Critical Characteristics
Gerhard Schilder, HOF, Sonderanlagenbau, Germany
• Equipment lay-out considerations
• Shelf package configuration
• Containment through isolation technology with CIP
• Automatic lyophiliser cleaning, loading/unloading system
10.00 - 10.30 PAT Application in Parenterals: In-Line
Non-Contact Product Inspection with NMR – New
Opportunities and Challenges in Process Control
Elena Trezza, BOC Edwards, The Netherlands
• Working principle of this new measurement technique
• 100% weight measurement based upon NMR
• Potential application on moisture determination on freeze
dried product
11.00 - 11.50 Case Study: Clean Room Decontamination
with VHP
Maria Wingren, Ferring, Sweden
The evolution of sporicidal gassing of isolators has allowed the
technique to be considered for cleanroom and RABS applications.
• Technology update
• Demonstrating the effectiveness and safety of the process
11.50 - 12.20 Case Experience: Impact of the Changes in
EU GMP Annex 1 on Environmental Monitoring
• The new requirements in Annex 1 of the EU GMP
• Selecting an airborne monitoring system
• System configuration
• Setting levels and limits in the context of the EU GMP
12.20 - 12.40 ISPE Sterile Manufacturing Facilities
Baseline® Guide
ISPE Representative invited
• Update about the scope of the review
• FDA’s involvement
• Key progress so far
• The aligned environmental cleanliness classifications
• Issues and input from industry
12.40 - 13.00 Questions and Answers – Workshop
Presentation
13.00 - 14.00 Lunch
14.00 - 15.30 Workshop: 21st Century Clean Room
Technology Expectations
Our industry has seen regulatory and technical developments
over the last six to seven years that are unprecedented –
isolators, ISO 14644 standards, the new FDA Aseptic
Processing Guidance, etc. The status quo has shifted
enormously and presents challenges for everyone.
Is the traditional “open cleanroom” technology an acceptable option? The following subjects will be explored in this
workshop session:
• RABS
• Grade A continuity
• Room decontamination
• Environmental monitoring
• Human intervention and manual operations
Delegates will be grouped for interactive discussions on the
selected topics. Each team will be coordinated by a team
leader.
Programme
15.30 - 16.00 Team Work Presentation
Summary presentations of the issues raised by the teams.
ISPE will prepare notes from the team work sessions for circulation to all attendees
16.00 - 16.30 Questions and Answers – Chair’s
Conference Close
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Update on the Draft ISPE Maintenance Baseline ® Guide
28-29 November 2005
Conference Leaders
Bob Lennon, Commissioning Agents, USA
Pietro Orombelli, Foster Wheeler, Italy
Who Should Attend
This Conference will provide an understanding of ISPE’s
Maintenance Baseline® Guide that is currently in
development. The authors will present the philosophy
and outline of the draft chapters of the Guide developed
to date.
•
•
•
•
•
Programme
The Guide is a much awaited addition to the Baseline
Pharmaceutical Engineering Series as maintenance
operations are becoming more critical to the operations
that they support from a cost and regulatory
perspective. In particular maintenance departments are
being asked to control costs whilst compliance
requirements are increasing.
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Pharmaceutical maintenance professionals
Operating departments served by maintenance providers
Production personnel
Research and development staff
QA and compliance personnel
ST
Simultaneous translation (English-Italian), is sponsored by
La traduzione simultanea è sponsorizzata da
Experiences will be shared through case studies by
maintenance professionals from major pharmaceutical
companies and suppliers.
Agenda
Monday, 28 November
The Maintenance Baseline Guide is currently in
development and is scheduled to be published in 2006.
Learning Objectives
At the conclusion of this conference, delegates will be
able to:
• Understand the philosophy and content of the
Baseline Guide (currently in development)
• Apply techniques to develop maintenance talent and
understand how maintenance organisations are
structured and when to outsource
• Describe experiences of maintenance issues from
regulatory inspections
• Explain how to use a risk-based approach to
maintenance and how to schedule maintenance in
production facilities with high utilisation
• Describe effective parts management
• Understand programmes for production and
maintenance staff – making operators aware of
routine and extraordinary situations
• Understand records management and archiving,
implementing a robust corrective action trail
• Compare preventative maintenance to corrective
maintenance, and understand costs of maintenance
and reducing production downtimes - selling
preventive maintenance to management
10.15 - 10.45 ISPE Maintenance Baseline Guide
Philosophy, Contents, and Status
• Guide objectives
• Strategy for guide preparation
• Outline of guide
• Schedule for guide release
• Discussion on approach and content of the guide
10.45 - 11.30 Authority Inspection on Maintenance:
Typical Situations – What You Should Avoid in a
Simulated Audit
• Typical weak points in maintenance management
• Questions we could expect
• Answers we should avoid
• What could be interesting for a regulatory inspector on
maintenance
11.30 - 12.15 Maintenance Approach: Baseline Practices,
Good Practices and Best Practices
Dennis Clark, Eli Lilly & Company, USA
• Meaning of baseline practices, good practices and best
practices
• Examples of baseline good and best practices in
maintenance
• Risks and opportunities of choosing one approach
12.15 - 13.45 Lunch
and Current Maintenance Approaches in Industry
14.30 - 15.15 Academic Point of View: Best Practice
from a University Professor
Vittorio Emmanuele, Univirsità di Ferrara, Italy
• Best maintenance practices in other areas (nuclear, petrol,
chemical, aeronautics, micro-electronics)
• Plant risk assessment, failures and their impact on
business continuity
• Predictive and proactive versus reactive maintenance
• Maintenance as reengineering of all that is already built
• Professional qualification of maintenance experts,
technical and managers
15.45 - 16.15 Change Control and Validation: A Case History
• How maintenance could impact production systems
• Why a change control is required
• Proposed methodology to change control
• Case history
16.15 - 17.00 Case Study: Defining Maintenance
Requirements as a Start to Implementing Maintenance
Excellence
Mark Jordan, AstraZeneca, UK
• The business drivers for adopting an optimised
maintenance process
• A pragmatic approach to RCM
• How we implemented across two sites covering £1.5Bn of assets
• The benefits achieved
• The next steps to ensure benefits are not lost
Day 1 Close
09.15 - 10.00 Case Study: Improvement in the
Maintenance Practice
Mike Buckland, Pfizer, USA
• Root cause failure analysis of a problematic reactor rotor
• Rotor constraint operating conditions
• The engineered solution
• Return on investment demonstrated
• The maintenance philosophy and its application at Pfizer
Sandwich
• Understanding the customer, system and equipment
• Controlling to achieve optimal reliability
10.00 - 10.45 CMMS Implementation of Today’s GMP
Production
Frank J Kuszpa, BMS, USA
• Company strategy and plant needs
• Integration of CMMS, data harmonisation
• CMMS and production systems
• 21CFR Part11 as key to document management
optimisation
11.15 - 12.00 How to be Compliant – The 10 Rules from a
Regulatory Inspector
Audny Stenbraaten, Norwegian Inspection Agency, Norway
A regulatory body’s point of view on:
• Regulatory concepts
• Maintenance programme
• Criticality assessment
• Computerised maintenance management systems
• Change management
• Maintenance documentation
• Spare parts and materials
• Training
12.00 - 12.45 GxP Maintenance: What’s in and What’s out
Based on an Analytical Approach
Tom Capelle, Abbot, USA
• Proposed methodology for determining direct impact and
indirect impact systems
• Application to maintenance practices
• Where maintenance baseline practices (GxP) should be
applied and where only good engineering practices need
to be applied
• Specific case studies
12.45 - 14.00 Lunch
14.00 - 15.45 Maintainability Review During Design:
How to Identify Critical Aspects
Claudio Rolandi, Academia SAS, Italy
• What is maintainability and what is involved (time to
change-over, identify failures, disassemble, spare parts
purchasing, repair, reassemble and calibrate)
• Regulatory constraints and design depending on best
practices (facility layout, machine structure, modularity,
component visibility, etc.)
• Technical solutions and innovations
• Actions by means of user requirement specification
Programme
13.45 - 14.30 Pharmaceutical Equipment Manufacturer’s
Point of View on Maintenance (Maintainability in the
Equipment Design)
Luigi Annoni, IMA Spa, Italy
• Technological trends in design for maintenance
• Maintenance requirements for pharmaceutical equipment
• Spare parts management
• Post-sales assistance in GMP regime
• Proposed approach for equipment management
ST
15.45 - 16.30 Maintenance: Cost or Investment?
Jim McCabe, ABB, UK
• Link between maintenance spend and asset performance
– some benchmarks
• Cost benefit analysis
• Life cycle costing
• Cost reduction in an outsourced maintenance contract
Conference Close
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Infrastructure: Validation, Compliance and Control in
30 November 2005
Conference Leaders
Sandro De Caris, IT Compliance Consultant, Italy
Hasse Greiner, Novo Nordisk A/S, Denmark
Who Should Attend
During this course, delegates will be presented with a
complimentary copy of ISPE’s new GAMP® Good
Practice Guide: IT Infrastructure Control and Compliance.
The new Guide facilitates global applications and
services, enabling the corporation to operate and
communicate safely across internal and external
borders.
• Platform managers, infrastructure process managers,
subject matter experts
• Information system managers
• Technology managers
• IT/IS validation and quality assurance subject matter
experts
The course focuses on the dynamic nature of an
infrastructure and discusses the processes and types of
technology deployed with emphasis on achieving and
maintaining control and compliance, taking advantage
of the overall risk level and widespread control
technology available.
Programme
The course discusses management processes for
servers, clients and networks and the way they affect an
organisation’s choice of strategies for operation,
security, compliance and control as well as the various
roles and responsibilities of the people involved.
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Learning Objectives
• Identify the infrastructure key elements: processes,
platforms and people
• Understand and use the terminology and main
compliance concepts
• Understand infrastructure processes and their role in
achieving and maintaining compliance
• See the infrastructure control and compliance
challenges from a regulatory standpoint
• Pinpoint the important aspects of platform
qualification and management: servers, clients,
networks
• Embrace system and infrastructure security
concerns: user access controls, platform hardening,
fire walling, patch management
• Avoid pitfalls in the allocation of roles and
responsibilities: system, platform and infrastructure
process owners, administrators, subject matter
experts, QA
ST
a Global IT Environment
ST
Agenda
10.15 - 11.15 The Regulatory Perspective
Sion Wyn, Conformity, UK
• Infrastructure – The regulator's perspective
• The importance of record integrity
• Risk-based approaches
• Update on Part 11
16.15 - 17.15 Infrastructure Security – Not Just an IT
Problem
David Stokes, MiServices Group, UK
• Typical security issues
• Technical risks and controls
• Logical and physical security
• People, processes and procedures
Conference Close
11.45 - 12.45 The GAMP® Good Practice Guide:
IT Infrastructure Control and Compliance
• Special Interest Group (SIG)
• Key concepts and terminology
• Structure of the guide
12.45 - 14.15 Lunch
Programme
14.15 - 15.15 Network Qualification and Management
Yves Samson, Kereon AG, Switzerland
• Identification of network qualification requirements and
constraints
• Identification of network configuration items
• Proposal for a network qualification strategy
• Network operation management
15.15 - 16.15 Server and Desktop Qualification and
Management
Finn Andersen, NNIT A/S, Denmark
• Identification of client and server qualification requirements
and constraints
• Identification of client and server configuration items
• Proposal for qualification strategies
• Client and server operation management
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Cleaning and Cleaning Validation
30 November - 1 December 2005
Conference Leaders
Andrew Provan, Bovis Lend Lease, UK
Pier Giorgio Valeri, CTP Technologie di Processo, Italy
This Conference will provide an understanding of the
regulations applicable to cleaning and its validation,
cleaning objectives and acceptance criteria.
Presentations will cover current thinking on cleaning
techniques, and design of a plant for optimising
cleaning, practical examples of achieving validated
cleaning and some alternatives to the cleaning process.
The presentations should enable delegates to
confidently develop a compliant cleaning programme
appropriate to their circumstances.
Learning Objectives
Programme
• Describe FDA and European agency expectations for
cleaning processes and cleaning validation
• Understand how to establish an optimum cleaning
process including discussions regarding dummy
testing
• Understand what type of cleaning agent should be
selected based on efficacy and residue detection
• Explain how to set acceptance criteria for cleaning
processes
• Describe the interfaces between cleaning and
bio-decontamination
• Understand how to set up a cleaning regime for
production areas (case study)
• Understand how to design a clean-in-place (CIP)
system (case study)
Who Should Attend
• Production personnel involved in defining cleaning
procedures
• QC personnel executing validation
• QA personnel involved in drafting and approving
cleaning validation protocols
• Equipment manufacturers
• Validation specialists
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Agenda
10.15 - 11.15 Regulatory Views
• What the inspector looks for
• Documentation – Design
• Documentation – Cleaning regime development
• Examples of good practice
11.15 - 12.15 Selection of Cleaning Detergents
Derio Illumi, Steris, Italy
• Detergents available
• Developing cleaning specs
• Testing products
• Coupons and removal aspects
12.15 - 13.45 Lunch
13.45 - 14.45 Spray Devices and Specification
Bo Knudsen, Alfa Laval Tank Equipment, Denmark
• Fixed and rotating heads
• Survey of existing plant
• Review of new vessel designs
• Design sprayball patterns and locations
• Testing – Riboflavin
• Verification – Jet detectors in heads
• Case studies
14.45 - 15.45 Hygienic Design of Equipment
Andrew Timperley, Campden and Chorleywood Food
Research Association (CCFRA), UK
• EHEDG – Approvals
• Testing of hygienic design
• CFD tests versus practical results
• Good hygienic practice
16.15 - 17.15 Designing CIP Systems for the Future
• Principles for vessel and pipework cleaning
• Instrumentation for maximum assurance
• Minimising water usage and water recycling
Day 1 Close
14.15 - 15.15 Use of TOC for Cleaning Validation
Giuseppe Ceramelli, CTP CHEM, Italy
• Typical installations
• Selection of instruments
• Calibrations
• Case studies
Conference Close
09.15 - 10.15 Case Study: Cleaning of Chemical API
Materials
Laura Castagno, Helsinn Chemicals SA, Switzerland
• Current Cleaning – Boil-up with solvents
• Drive for replacement (costs, VOC, effluent, green
chemistry)
• Aquatic based detergents available
• Cleaning regime
• Effluent treatment and disposal
Programme
10.45 - 11.45 Development of Analytical Methods –
Swabbing and Sample Recovery
Mike Douglas, Bovis Lend Lease, UK
• Spiking of coupons
• Recovery of sample
• Analytical test methods
• What can go wrong
11.45 - 12.45 Development of a CIP Regime – A Case
Study
Tim Owen, OCD, UK
• Analytical reagent manufacturing
• High sensitivity to contamination
• URS – Review of requirements
• Testing cleaning solution effectiveness
• How clean is clean? – Methods for assessed equipment
cleanliness
12.45 - 14.15 Lunch
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Risk Management and ICHQ9
30 November - 1 December 2005
Conference Leaders
David Selby, Selby Hope International, UK
Programme
Luca Vietry, CSV Life Science Srl, Italy
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Who Should Attend
The EU and FDA regulators’ recent introduction of the
concept of risk management into many aspects of GXP
compliance has caused the pharmaceutical industry to
take a serious look at how it does business. This
Conference will provide an overview of the issues
commonly faced in a highly regulated industry and
demonstrate, though current examples, how the
industry is responding to the challenges arising from the
introduction of risk management.
• Professionals involved in the pharmaceutical supply
chain who are new to the industry, or industry
veterans who want to learn about the new
approaches to risk management
• Production and operations managers
• Quality assurance and quality control executives
• Process engineers
• Maintenance engineers
• Validation executives
This Conference will bring you up to date on the current
thinking for applying risk management in the highly
regulated pharmaceutical manufacturing arena,
including an update on the ICH Q9 work and the FDA's
initiative, “Pharmaceutical GMPs for the 21st Century - A
Risk-Based Approach.” You'll also hear examples of
how the FDA is approaching inspections and how the
risk management concept will evolve into the future.
Agenda
Additionally you will hear how companies have applied
the concepts of risk management in their compliance
activities and also how other regulated industries make
use of risk management.
11.15 - 12.15 European Regulatory Approach to Risk
Management
Speaker to be confirmed
Learning Objectives
• Understand the principles of risk management and
the regulatory expectations
• Describe the benefits received from the risk based
approach applied to the activities of facility planning,
revamping and new design
• Explain the use of risk management in integrated
commissioning and qualification projects
• Explain the use of risk management in validation
planning
• Explain the use of risk management for applying
controls to electronic records
• Understand the implications of the FDA's risk-based
approach for the pharmaceutical industry
• Discuss how the initiative is developing
• Appreciate the issues raised by examining current
examples
10.15 - 11.15 FDA Regulatory Expectations with Regard
to Risk
Speaker to be confirmed
12.15 - 13.30 Lunch
13.30 - 14.30 Risk Assessment – Lessons Learnt From
Other Industries 1 – Aerospace: Some Aerospace
Specificities and Trends Significant for a Risk
Assessment Approach
Alain Dupas, Collège de Polytechnique, France
• Specificities
• Very complex systems (number of parts: 100,000s)
• Integration in larger “systems of systems”
• Huge unitary cost (US$ 10/100s millions) and small series
(10s to 100s units)
• Long development cycle and innovative technologies
• Failures associated with large human and financial losses
• Pressure on operational costs
• Globalisation of manufacturing and issues of subcontractors selection
• Trends
• Risk becoming a major corporate management problem
(reliability and failure impact results and market
perception)
• Technical risk difficult to apprehend by top
management, creating strong demand for clear and
operative risk assessment tool
• Statistical risk assessment often irrelevant
• Risk assessment must become deterministic and part of
decision making process
Risk must not be evaluated but under control: risk
management becomes a core issue - “Failure is not an
Option”
14.30 - 15.00 An Overview of ICHQ9
• Introduction to quality risk management principles as
defined in Q9a
• The quality risk management process
• Integration of quality risk management into industry and
regulatory operations
• Implications for industry
15.30 - 16.15 Mitigating Project Risk – A Case Study
from the Rail Industry
Nick Guiffida, Telelogic, UK
• Case study: looking at the issues of a very well known
company in the transport industry
• Details of the company’s objectives and issues associated
with meeting these objectives
• Overcoming the issues by industry consultation
• Benefits the company gained from this strategy
• Common issues that the rail industry has with the
pharmaceutical industry
16.15 - 17.15 Risk Management Methodology
Session description not available at time of printing
17.15 - 17.45 Question and Answer Session – Chair’s
Day 1 Close
09.15 - 10.15 Risk Assessment GMP versus Health and
Safety
Lesley Burgess, AstraZeneca, USA
• The need to adopt a science-based risk assessment
approach to sourcing and containment decisions
• Using a holistic approach to risk assessment to
accommodate the needs of multiple business drivers
• Ensuring a clear distinction between using criteria for
assessing risk to patients in the community and personnel
in the workplace
• The need to assess on a case-by-case study
10.45 - 11.45 Implementing a Risk Assessment Process
in a Global R&D Organisation
Heather Watson, GlaxoSmithKline, UK
• Case study: implementing a CSV RA process
• Benefits of working as a global cross functional team
• Reduced validation processes
• Harmonised practices
11.45 - 12.45 Case Study: Use of the Risk Assessment
for Equipments and Facilities Qualification
Stefano Arena, Cardinal Health, Italy
• Quality risk management and ICHQ9 guideline (a new
approach)
• How to perform a system impact assessment
• Risk analysis and definition of a qualification plan
• Equipment and facility qualification
12.45 - 14.15 Lunch
14.15 - 15.15 Commissioning and Qualification for a
Containment Manufacturing Facility
Gabriel Caciula, Pfizer, Global Quality Technical Services
Europe, Belgium
• Pfizer has recently applied the principles developed in the
ISPE Commissioning and Qualification Baseline® Guide to
the implementation of a tablet manufacturing project in Italy
• A number of challenges became obvious during the
implementation of the theory into practice
• The risk based approach contained in the system and
component level impact assessments proved a key factor in
the success of the project
• Lessons learned during the project were used to improve
the commissioning and qualification program to be applied
across all Pfizer sites
Programme
•
15.15 - 15.45 Project Management and Informal Risk
Management for a SVP Dosage Forms Formulation and
Filling Facility – The Case of Polpharma New Ampoules
Department
Marzio Mercuri, Polpharma, Poland
• Project goals and critical aspects address and definition
• Criteria for existing / new systems cGMP compliance GAP
analysis
• Management techniques for facility design critical aspects
and risks mitigation control
• Lessons learned
Conference Close
15
Global Information Systems: Validation, Compliance and
1 December 2005
Conference Leaders
Randy Perez, Novartis, USA
During this course, delegates will be presented with a
complimentary copy of ISPE’s new GAMP® Good Practice
Guide: Global Information Systems Control and
Compliance. The new Guide describes global information
system life cycle management in light of diverse local
regulations.
The course discusses some system architectures and the
way they affect an organisation's choice of project
strategies for development, validation and operation.
It will also address strategies for establishing the most
efficient system management and data management
processes for a global system to ensure it remains in a
validated state.
Learning Objectives
Programme
• Understand project management concerns for
system validation in a global, multicultural and
multilingual environment
• Describe how global system architecture affects
validation strategies
• Understand the importance and usage of effective
traceability matrices
• Explain how system management procedures should
be adjusted to fit a global environment
• Understand how data management requirements
may differ for global systems
Who Should Attend
• Information system managers, platform managers
and subject matter experts
• Owners of globally deployed GxP systems
• Business users of global systems who are involved in
validation efforts
• Technology managers
• IS validation and quality assurance subject matter
experts
16
ST
Control in a Global IT Environment
09.00 - 09.30 Welcome and Introduction: SIG
Background and Document Overview
• Problem statement
• Challenges and opportunities
09.30 - 10.30 Handling International Differences, from
Regulatory Issues to Corporate Culture
Winnie Cappucci, Berlex, USA
• Regulatory commonalities and conflicts
• Integrating team members from different cultures
• Keeping smaller players involved
11.00 - 12.00 Validation Planning and Reporting
• System ownership
• Leveraging resources
• Coordinating reporting
• Documentation management
12.00 - 13.00 Planning Test and Managing Global
Testing
Peter Robertson, AstraZeneca, UK
• Leveraging system architecture
• Managing global traceability for test planning
• Who tests what and where?
16.00 - 16.30 Case Study: Upgrade of a Global Drug
Safety System
Elien Young, Novartis, USA
• What was already in place
• Managing key system aspects
• Testing strategies that worked
• Other keys to success
16.30 - 17.00 Case Study: Structured Approach for
Control Design and Plant Data Integration in the cGMP
Automated Plant for API Production
Marco Banti, ABB PS&S, Italy
• The impact of S88 Standard in designing a URS for a
common architecture from process control operation
and production management
• The value of information in an integrated architecture,
handling batch operations, maintenance, plant assets,
historian and compliance issues
• Global traceability for batch operations, manufacturing
operation and plant asset optimisation
• How to define clear project task responsibilities, define
IQ/OQ issues and meet 21 CFR Part 11 requirements
Conference Close
13.00 - 14.00 Lunch
14.00 - 15.00 System and Data Management
• Global change control
• Global configuration management
• Security management
• Optimising and retaining the value of data
Programme
Agenda
Thursday, 1 December 2005
ST
15.00 - 15.30 Case Study: Applying Global Information
Systems - Control and Compliance Principles in
Central and Eastern Europe
Carl Turner, PL Consultancy, UK
• A small town called Europe
• ERP project Poland and beyond
• Future development and tools
17
General Information
Venue
Milan Marriott Hotel
Via Washington 66
I-20146 Milan, Italy
Tel: +39-0248521
Fax: +39-024818925
www.marriotthotels.com
Description
General Information
The five-star Milan Marriott Hotel is located on Via
Washington within a few minutes of the International
Fair Grounds. The hotel provides daily shuttles as
courtesy for the guests and is located nearby
prestigious shops and local restaurants.
The 312 rooms and 10 suites are elegantly furnished,
providing all traditional comforts, air conditioning,
minibar, in room safety box, satellite TV, direct dial
telephone with voice mail, telephone in bathroom and
services the discriminating traveller is accustomed to.
Guests can access the fitness room, the boutique and
the business centre. La Brasserie de Milan restaurant
features an open view kitchen, for the best regional
and Mediterranean cuisine.
Accommodation
A block of rooms has been reserved at the Milan
Marriott Hotel for conference participants, at the
preferential rate of €160 for a single room and €180 for
a double room (including breakfast and taxes). This offer
is limited and we encourage you to register as early as
possible.
To book your accommodation at the Milan Marriott
Hotel, please send your accommodation reservation
request together with your conference registration to
ISPE Registration Services (fax: +32-2-743 1584).
Reservations cannot be processed and guaranteed
without a credit card number.
Accommodation and any extras are to be settled by
each delegate directly with the hotel upon check-out.
Changes in bookings or cancellations are accepted only
in writing directly to ISPE Registration Services prior to
the event and no later than 10 November 2005. The
hotel is entitled to charge the entire value of the room
18
reservation in case of cancellations received later than
48 hours before arrival.
Other hotel options are at your own arrangements.
Badges
Name badge must be worn at all times. Delegates not
wearing their badges will be denied entrance to
conferences.
Transportation
There are two international airports in Milan:
Malpensa is 50 km away from the Marriott Hotel. A bus
service is available from the airport to the hotel, at
approximately € 6 (one way). Please note that this is not
a service operated by the Marriott Hotel. The estimated
taxi fare from the airport to the hotel is approximately
€ 80 (one way). You can also use Malpensa Express
Trains (departure from Terminal 1) to reach the central
station. From there, take the subway to “Wagner”
(approximately five minutes walk to the hotel).
Linate is 20 km away from the Marriott Hotel. A bus
service is available from the airport to the hotel, at
approximately € 3 (one way). Please note that this is not
a service operated by the Marriott Hotel. The estimated
taxi fare from the airport to the hotel is approximately
€ 40 (one way).
ISPE Registration Desk Hours
The ISPE Registration Desk will be open during the
following time:
Sunday, 27 November
17.00 – 19.00
Monday, 28 November
08.00 – 17.00
08.00 – 19.00
08.00 – 17.00
08.00 – 10.00
Recommended Dress Code
Business Casual.
® Baseline and GAMP are registered trademarks of ISPE
Networking Opportunities
ISPE Italy Affiliate
Social Evening
Monday, 28 November
Networking Receptions
(Monday, 28 November and Wednesday, 30 November)
Lunches and Coffee Breaks
Enjoy a complimentary lunch to gear up for the afternoon’s
activities. A hot cup of coffee or tea in the exhibition area
will offer you a well-deserved break in a busy day.
Mark Your Calendar!
■ ISPE Copenhagen Conferences
24-27 April 2006
Marriott Hotel
Copenhagen, Denmark
A taste of Milanese specialities and Italian wines in one
of the city’s most elegant ancient Museums.
Milan has been considered one of the most fascinating
cities in the world, due to its canals, called "Navigli". In
the ancient atmosphere of Museo dei Navigli, ISPE’s
Italian Affiliate will organise a cocktail reception followed
by a Milanese dinner.
On the way to Museo dei Navigli, you will be able to
briefly enjoy some of Milan’s most impressive sites,
passing nearby Castello Sforzesco, the magnificent
Piazza del Duomo and La Scala, Italy’s world famous
theatre.
18.45
Departure by bus from the Marriott Hotel
19.30
Arrival at Museo dei Navigli (via San Marco)
19.40
Welcome Cocktail
20.30
Special Milanese Dinner, with local specialities
and Italian wines
22.30
Departure by bus from Museo dei Navigli
22.45
Arrival at the Marriott Hotel
■ ISPE Vienna Congress
18-22 September 2006
International Hotel
Vienna, Austria
■ ISPE Brussels Conferences
4-7 December 2006
Sheraton Hotel and Towers
Brussels, Belgium
For more information contact: [email protected]
or visit: www.ispe.org/GlobalCalendar
Networking Opportunities
These two receptions, at the Marriott Hotel, are an excellent
opportunity to meet with exhibitors and learn about their
newest technologies in a fun and casual environment. Enjoy
food and drinks with your colleagues!
Experience the elegance of Milan’s monuments and
gastronomic specialities. If you wish to attend this
event, please tick the appropriate box in the registration
form. The cost per person is € 60. Places are limited.
19
Table Top and Sponsorship Opportunities
Table Top Exhibits and Sponsorship Opportunities
Sponsorship Opportunities
Table Top Exhibits
ISPE offers high-visibility, low-cost exclusive sponsorship
opportunities for suppliers to the global healthcare
manufacturing industry.
ISPE offers companies the opportunity to present their
products face-to-face with potential customers in an
informal atmosphere in conjunction with the ISPE Milan
Conferences.
• A literature display table near the food/beverage
function area
• Literature display table in designated area
• Company name printed on event materials (agendas)
distributed to delegates
• Company logo on promotional material (brochures,
postcards, posters) provided that sponsorship is
booked on time
Morning and afternoon refreshments are served in the
exhibition area to attract the maximum number of
conference participants to see your display.
ISPE offers three different opportunities:
• 28 - 29 November 2005 (2 days)
• 28 November - 1 December 2005 (4 days)
• 30 November - 1 December 2005 (2 days)
• Company logo on event page of ISPE Web site, up to
three months prior to event
ISPE Europe’s Table Top Exhibits typically sell out fast!
There are limited spaces left.
• Company logo displayed on signs at food/beverage
functions
To book your Table Top, contact:
• Sponsor ribbons for all company employees in
attendance
To book your sponsorship, please contact:
Isabella Vanpeteghem
European Events Logistics Coordinator
Tel: +32-2-743 4422 / Fax: +32-2-743 1584
E-mail: [email protected]
Françoise Rajewski
European Sales Manager
Tel: + 32-2-743 1581 / Fax: +32-2-743 1578
List of Exhibitors
BOC Edwards
Crane Process Flow Technologies Ltd.
CPS Extact
Entegris
Erea
Foster Wheeler
Hecht Anlagenbau GmbH
Honeywell
Howorth Airtech Ltd.
Isolation Solutions SA
MRO Software
NNE
Novaseptic
Pharmadule
SAE-STAHL GmbH
For an updated list of Exhitors,
visit www.ispe.org/GoTo_MilanConferences
20
Registration and Cancellation Policies
Registration Fees
Conferences registration fees include:
• Conference material
• Refreshment breaks
• Lunches
• Networking Reception
• Exhibit hall access
If you have registered as a nonmember, you are entitled to
a complimentary one-year membership in ISPE. To receive
an ISPE membership application form, please tick the box
on the registration form. Your membership application must
be returned to ISPE within 30 days in order to activate your
membership.
ISPE membership is individual and must be paid in full to
qualify for the Member fee. If you have questions regarding
your membership status, please contact ISPE by
tel: + 32-2-743 4422 or fax: + 32-2-743 1584.
Payment
Payment must accompany registration form. Registration
will not be processed nor confirmed without payment in
Euro (€). All registrations sent by fax must include the
necessary payment information. American Express, Visa or
EC/MasterCard is accepted. Please complete the
appropriate spaces and sign the registration form.
Early Registration Deadline
To benefit from the early registration deadline, payment
must be received before 14 October 2005. After this date,
you will be charged the standard registration fee.
Confirmation
Upon receipt of payment, a proof of payment will be sent
to you, along with your confirmation letter (time permitting).
Hotel accommodation is not included in the registration fee.
Please present your registration confirmation letter at the
ISPE Registration Desk at the Milan Marriott Hotel. You will
receive your Conference materials and personal name
badge.
If you do not receive your confirmation letter, please
contact ISPE at:
ISPE Registration Services
Avenue de Tervueren, 300
B-1150 Brussels
Belgium
Tel: + 32-2-743 4422
Fax: + 32-2-743 1584
In order to be listed in the official delegate roster, you must
be registered and paid by 18 November 2005.
Cancellation Policies
Full refunds, less a handling fee of € 100 per registrant, will
be granted to requests received in writing before or on
10 November 2005. No refunds will be granted for requests
received after 10 November 2005. Telephone cancellations
will not be accepted.
Liability
In case of Government intervention or regulation, military
activity, strikes or any other circumstances that make it
impossible or inadvisable for the ISPE Milan Conferences
to take place at the time and place provided, the
participant shall waive any claim for damages or
compensation except the amount paid for registration after
deduction of actual expenses incurred in connection with
the Conferences and there shall be no future liability on the
part of either party.
Substitutions
If a delegate is unable to attend, substitutions will be
accepted; however, nonmembers substituting for
Members must pay the difference in fees prior to the start
of the event. ISPE can not be held responsible for lost
airfare due to cancellations.
ISPE Notice
The speakers invited to present ISPE’s programmes are
leading professionals in their field. Should it be necessary,
substitutions may be made. Every precaution is taken to
ensure accuracy, but ISPE cannot accept responsibility for
the accuracy of information distributed or contained in
these programmes, or for any other opinion expressed.
Group Discounts
Group of Two Save 10%: Two participants from the same
company location attending conferences at a single venue
save 10% on the registration fees.
Group of Three or More Save 15%: Three participants from
the same company location attending conferences at a
single venue save 15% on the registration fees.
Discounts cannot be combined and Member and
nonmember pricing applies. Team registrations must be
submitted at the same time. Substitutions will be
accepted.
Please contact ISPE Registration Services to receive a
Group
Discount
Registration
Form
or
visit:
www.ispe.org/GoTo_MilanConferences.
Emerging Economy Countries Discount
ISPE is offering 25% discount on the registration fee to
Members from Emerging Economy countries. To review the
list of eligible countries visit:
www.ispe.org/EmergingEconomyList.
The discount will automatically apply when registration is
processed.
Registration Form
MilConf2
I. Delegate Information
Please return to:
ISPE Registration Services
B-1150 Brussels
Belgium
Tel: +32-2-743 4422
Fax: +32-2-743 1584
ISPE Member: ❐ Yes, membership number
Prefix:
First Name:
Mid Name:
Job Title:
Company:
Address:
City:
Postal Code:
Telephone:
Fax:
Mobile:
E-mail:
Company VAT Number:
❐ No
Last Name:
Country:
❐ I wish to keep my data confidential and it is given only for use by ISPE and its local Affiliates and Chapters.
❐ I do not wish my information to be printed in the Membership Directory or on Conference Attendee Listings.
II. Conferences Registration
Please select the conference you wish to attend (one conference per two-day event)..
Prices below do NOT include VAT.
Payment received
Payment received
after 14 October
on or before 14 October
Member Nonmember* Member Nonmember*
❐ Full Conference (28 November - 1 December). Please select below the
conferences you will be attending (one conference per two-day event)
Student**
Member
Nonmember
Government
/Faculty
€ 1540
€ 1890
€ 1990
€ 2340
€ 200
€ 230
€ 1020
€ 855
28-29 November 2005
❐ Sterile Product Processing for the 21 Century
€ 855
€ 1035
€ 1035
€ 1105
€ 1105
€ 1285
€ 1285
€ 100
€ 100
€ 130
€ 130
€ 510
€ 510
❐ Update on the Draft ISPE Maintenance Baseline® Guide and Current
Maintenance Approaches in Industry ST
€ 855
€ 1035
€ 1105
€ 1285
€ 100
€ 130
€ 510
€ 450
€ 630
€ 580
€ 760
€
€
80
€ 255
€ 855
€ 855
€ 1035
€ 1035
€ 1105
€ 1105
€ 1285
€ 1285
€ 100
€ 100
€ 130
€ 130
€ 510
€ 510
€ 450
€ 630
€ 580
€ 760
€
€
€ 255
❐ Containment Technology Forum
st
30 November
❐ Infrastructure: Validation, Compliance and Control in a Global IT Environment ST
50
30 November - 1 December
❐ Cleaning and Cleaning Validation
❐ Risk Management and ICHQ9
1 December
❐ Global Information Systems: Validation, Compliance and Control in a Global IT Environment ST
50
80
* This nonmember rate entitles you to a one-year membership in ISPE at no additional charge.
** Proof of full-time student status is required.
❐ Please tick this box if you wish to become a Member. An ISPE Membership Application form will be sent to you, which
must be returned to ISPE within 30 days in order to activate your membership.
❐ First time attendee.
III. Social Evening
❐ Yes, I will participate in the ISPE Italy Affiliate Social Evening on Monday, 28 November (the cost per person is € 60).
Please indicate below the name of accompanying person.
First Name:
Last Name:
(for additional persons, please make copies)
IV. Method of Payment
20 % Italian VAT is applicable. Registrations will not be accepted without payment.
Sub-Total:
€
ISPE Italy Affiliate Social Evening
x € 60
€
20 % VAT:
€
TOTAL DUE:
€
❐ Credit Card:
❐ AMEX
❐ VISA
❐ EC/MasterCard
Credit Card number:
Cardholder’s name:
Signature:
Expiry Date:
V. Special Needs (dietary):
VI. Hotel Reservation
Please make the following reservation for me at the Milan Marriott Hotel, Via Washington 66, I-28146 Milan, Italy:
❐ Single € 160 / ❐ Double room € 180 (Including breakfast and taxes)
❐ Smoking / ❐ Non-smoking
(Subject to availability)
Arrival date:
Departure date:
Please guarantee my reservation with the following credit card:
❐ AMEX
❐ VISA
Credit Card number:
Cardholder’s name:
❐ EC/MasterCard
Expiry Date:
Signature:
VII. Signature
By signing, I agree with the ISPE Registration and Cancellation Policies (see page 21).
Date:
Signature:
Engineering Pharmaceutical Innovation
ISPE European Office
B-1150 Brussels
Belgium
Tel: +32-2-743 4422
Fax: +32-2-743 1584
www.ispe.org

Winter Conference

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