ISPE Milan Conferences - Kereon AG

ISPE Milan Conferences 

Marriott Hotel • Milan, Italy 

28 November >01 December 2005 

UPDATED 

PROGRAMME 

28-29 November 

• Containment Technology Forum 

• Sterile Product Processing for the 21 st 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 

• Programme at-a-Glance 3 

• Programme 4-17 

• General Information 18 

• Networking Opportunities 19 

• Table Top and Sponsorship Opportunities 20 

• Registration and Cancellation Policies 21 

• More than 90 speakers 

• A Table Top Exhibition including around 30 different companies 

• Two Networking Receptions 

• ISPE Italy Affiliate Social Evening 

Over 350 attendees are expected! 

• Registration Form 22 

Platinum Sponsors 

Silver Sponsors 

Join us in Milan, 

Register today! 

Simultaneous translation 

ST 

is sponsored by 

Engineering Pharmaceutical Innovation

Programme at-a-Glance 

Monday, 28 November Tuesday, 29 November Wednesday, 30 November Thursday, 1 December 

Containment Technology Forum 

Sterile Product Processing for the 21 st 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 

Networking Reception 

Italy Affiliate Social Evening 

ST 

Table Top Exhibition Table Top Exhibition Table Top Exhibition Table Top Exhibition 

Networking Reception 

For conference descriptions, go to pages 4-17 

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: kristien@associationhq.com, tel: + 32-2-743-4422, or visit www.ispe.org 

3

Containment Technology Forum 

28-29 November 2005 

Conference Leaders 

Giorgio de Castiglioni, Pharmatech Srl, Italy 

Johannes Rauschnabel, Robert Bosch GmbH, Germany 

Programme 

Conference Description 

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. 

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. 

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. 

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 

Who Should Attend 

• 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 

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 

4

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 

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 

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 

Tuesday, 29 November 

09.00 - 09.15 Recap of Day 1 – Introduction of Day 2 


09.15 - 10.15 Containment Update on ISPE Baseline ® Guides 

ISPE Representative invited 

• Bulk Pharmaceutical Chemicals Baseline Guide 

• Particulate measurement (SMEPAC) 


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 


Conference Close 



Programme 


5

Sterile Product Processing for the 21 st Century - 



Gordon Farquharson, Bovis Lend Lease Technology, UK 

Nunzio Genoni, Jacobs Italia SpA, Italy 

Programme 

6 


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. 

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. 


At the conclusion of this seminar, delegates will be able to: 

• 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 ® 

Guide 

• Apply state of the art environmental monitoring 

• See how advanced aseptic techniques can influence 

their business 


• 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 

Agenda 





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 21 st 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 

11.45 - 12.15 Regulatory Discussion 

12.15 - 13.30 Lunch 

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 

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: 21 st 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. 

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 





Programme 

7

Update on the Draft ISPE Maintenance Baseline ® Guide 



Bob Lennon, Commissioning Agents, USA 

Pietro Orombelli, Foster Wheeler, Italy 


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. 


• Pharmaceutical maintenance professionals 

• Operating departments served by maintenance providers 

• Production personnel 

• Research and development staff 

• QA and compliance personnel 

Programme 

8 

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. 

Experiences will be shared through case studies by 

maintenance professionals from major pharmaceutical 

companies and suppliers. 

The Maintenance Baseline Guide is currently in 

development and is scheduled to be published in 2006. 


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 

Agenda 




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 

ST 

Simultaneous translation (English-Italian), is sponsored by 

La traduzione simultanea è sponsorizzata da

and Current Maintenance Approaches in Industry 

ST 

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 

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 

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 






Programme 

9

Infrastructure: Validation, Compliance and Control in 

30 November 2005 


Sandro De Caris, IT Compliance Consultant, Italy 

Hasse Greiner, Novo Nordisk A/S, Denmark 


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. 

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. 


• Platform managers, infrastructure process managers, 

subject matter experts 

• Information system managers 

• Technology managers 

• IT/IS validation and quality assurance subject matter 

experts 

ST 


La traduzione simultanea è sponsorizzata da 

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. 

Programme 



• 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 

10

a Global IT Environment 

ST 

Agenda 

Wednesday, 30 November 




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 


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 

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 

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 






Programme 


11


30 November - 1 December 2005 


Andrew Provan, Bovis Lend Lease, UK 

Pier Giorgio Valeri, CTP Technologie di Processo, Italy 

Programme 


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. 



• 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) 


• 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 

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 

12


Day 1 Close 




Thursday, 1 December 




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 


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 

14.15 - 15.15 Use of TOC for Cleaning Validation 

Giuseppe Ceramelli, CTP CHEM, Italy 

• Typical installations 

• Selection of instruments 

• Calibrations 

• Case studies 





Programme 


13


30 November - 1 December 2005 


David Selby, Selby Hope International, UK 

Luca Vietry, CSV Life Science Srl, Italy 

Programme 

14 


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. 

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 21 st 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. 

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. 



• 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 


• 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 

Agenda 





10.15 - 11.15 FDA Regulatory Expectations with Regard 

to Risk 

Speaker to be confirmed 

11.15 - 12.15 European Regulatory Approach to Risk 

Management 

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 




Thursday, 1 December 



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 

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 






Programme 

15

Global Information Systems: Validation, Compliance and 

1 December 2005 



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. 

ST 


La traduzione simultanea è sponsorizzata da 

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. 



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 


• 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

Control in a Global IT Environment 

ST 

Agenda 

Thursday, 1 December 2005 

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? 

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 

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 


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 





Programme 


17

General Information 

General Information 

Venue 

Milan Marriott Hotel 

Via Washington 66 

I-20146 Milan, Italy 

Tel: +39-0248521 

Fax: +39-024818925 

www.marriotthotels.com 

Description 

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. 

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: 

18 

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 

Sunday, 27 November 17.00 – 19.00 

Monday, 28 November 08.00 – 17.00 

Tuesday, 29 November 08.00 – 19.00 

Wednesday, 30 November 08.00 – 17.00 

Thursday, 1 December 08.00 – 10.00 

Recommended Dress Code 

Business Casual. 

® Baseline and GAMP are registered trademarks of ISPE

Networking Opportunities 

ISPE Italy Affiliate 

Social Evening 

Networking Receptions 

(Monday, 28 November and Wednesday, 30 November) 

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! 

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 

■ ISPE Vienna Congress 

18-22 September 2006 

International Hotel 

Vienna, Austria 


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 

Networking Opportunities 

■ ISPE Brussels Conferences 

4-7 December 2006 

Sheraton Hotel and Towers 

Brussels, Belgium 

For more information contact: europeregistrations@ispe.org 

or visit: www.ispe.org/GlobalCalendar 

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 Exhibits and Sponsorship Opportunities 

Table Top and Sponsorship Opportunities 

Sponsorship Opportunities 

ISPE offers high-visibility, low-cost exclusive sponsorship 

opportunities for suppliers to the global healthcare 

manufacturing industry. 

• 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 

• Company logo on event page of ISPE Web site, up to 

three months prior to event 

• Company logo displayed on signs at food/beverage 

functions 

• Sponsor ribbons for all company employees in 

attendance 

To book your sponsorship, please contact: 

Françoise Rajewski 

European Sales Manager 

Tel: + 32-2-743 1581 / Fax: +32-2-743 1578 

E-mail: francoise@associationhq.com 

Table Top Exhibits 

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. 

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) 

ISPE Europe’s Table Top Exhibits typically sell out fast! 

There are limited spaces left. 

To book your Table Top, contact: 

Isabella Vanpeteghem 

European Events Logistics Coordinator 

Tel: +32-2-743 4422 / Fax: +32-2-743 1584 

E-mail: isabella@associationhq.com 

20 

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 

www.ispe.org/GoTo_MilanConferences

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 

E-mail: europeregistrations@ispe.org 

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.


Please return to: 

ISPE Registration Services 



Belgium 

Tel: +32-2-743 4422 

Fax: +32-2-743 1584 

I. Delegate Information 

Registration Form 

ISPE Member: ❐ Yes, membership number 

❐ No 

Prefix: First Name: Mid Name: Last Name: 

Job Title: 

Company: 

Address: 

City: Postal Code: Country: 

Telephone: 

Fax: 

Mobile: 

E-mail: 

Company VAT Number: 

❐ 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. 

MilConf2 

II. Conferences Registration 

Please select the conference you wish to attend (one conference per two-day event). 

Prices below do NOT include VAT. 

❐ Full Conference (28 November - 1 December). Please select below the 

conferences you will be attending (one conference per two-day event) 


❐ Containment Technology Forum 

❐ Sterile Product Processing for the 21 st Century 

❐ 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 

30 November - 1 December 

❐ 

❐ 



1 December 

❐ Global Information Systems: Validation, Compliance and Control in a Global IT Environment 

ST 

ST 

* 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) 

Payment received 

on or before 14 October 

Member Nonmember* 

€ 1540 € 1890 € 1990 € 2340 € 200 € 230 € 1020 

€ 855 € 1035 € 1105 € 1285 € 100 € 130 € 510 

€ 855 € 1035 € 1105 € 1285 € 100 € 130 € 510 

€ 855 

€ 450 

€ 855 

€ 855 

Payment received 

after 14 October 

Member Nonmember* 

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: 

Student** 

Member Nonmember 

€ 1035 € 1105 € 1285 € 100 € 130 € 510 

€ 630 € 580 € 760 € 50 € 80 € 255 

€ 1035 € 1105 € 1285 € 100 € 130 € 510 

€ 1035 € 1105 € 1285 € 100 € 130 € 510 

€ 450 € 630 € 580 € 760 € 50 € 80 € 255 

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 ❐ EC/MasterCard 

Credit Card number: 

Expiry Date: 

Cardholder’s name: 

Signature: 

VII. Signature 

By signing, I agree with the ISPE Registration and Cancellation Policies (see page 21). 

Date: 

Signature: 

Government 

/Faculty

Engineering Pharmaceutical Innovation 

ISPE European Office 



Belgium 

Tel: +32-2-743 4422 

Fax: +32-2-743 1584 

E-mail: ispe@associationhq.com 

www.ispe.org

ISPE Milan Conferences - Kereon AG

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