ISPE Milan Conferences - Kereon · ISPE Milan Conferences Engineering Pharmaceutical Innovation...

ISPE Milan ConferencesMarriott 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

30 November• Infrastructure: Validation, Compliance and Control in a Global IT Environment

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

The Conferences will also include a Social Evening organised by the ISPE ItalyAffiliate, two networking receptions, and a Table Top exhibition.

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www.ispe.org/GoTo_MilanConferences

ISPE Milan Conferences

Engineering Pharmaceutical Innovation

About the EventThe ISPE Milan Conferences are part of the 2005 ISPE ContinuousAdvancement Programme. The event includes:

• Seven Conferences on the pharmaceutical industry trends and challenges

• More than 90 speakers

• A Table Top Exhibition including around 30 different companies

• Two Networking Receptions

• ISPE Italy Affiliate Social Evening

Join us in Milan,Register today!

• 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

• Registration Form 22

Platinum Sponsors

Silver Sponsors

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Over 350 attendees are expected!

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Global On-line Career Centre for the Pharmaceutical IndustryLooking for an exciting new job? Interested in reaching the most qualified candidates? Make your searchfast, easy, targeted and successful. The ISPE Global On-line Career Centre, at wwwwww..iissppee..oorrgg, is availableto 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 curriculumvitaes (CVs), entry to a targeted group of pharmaceutical manufacturing professionals and the ability toconduct 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 toa 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

For conference descriptions, go to pages 4-17

Programme at-a-Glance

Infrastructure: Validation,Compliance and Control in aGlobal IT Environment

Networking Reception Networking Reception

Italy Affiliate Social Evening

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Global Information Systems:Validation, Compliance andControl in a Global ITEnvironment

Cleaning and Cleaning Validation

Risk Management and ICHQ9

Update on the Draft ISPE Maintenance Baseline® Guide and Current Maintenance Approaches in Industry STST

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Sterile Product Processing for the 21st Century - Innovations,Guidelines and Regulatory Expectations

Containment Technology Forum

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

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

Conference Leaders

Giorgio de Castiglioni, Pharmatech Srl, Italy

Johannes Rauschnabel, Robert Bosch GmbH, Germany

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Containment Technology Forum

Conference DescriptionThis Conference will discuss the latest developments inthe containment of potent compounds for themanufacture of bulk active pharmaceutical ingredientsand the production of drugs in their final dosage form.

The challenges of complying with health and safetyrequirements, current GMP demands and new develop-ments in engineering and methodology will all bedeveloped and discussed in detail.

Leading international speakers will provide a globalperspective of the regulatory expectations forcompliance with health and safety and GMP. Riskevaluation professionals will discuss the development ofa practical and compliant risk assessment strategy.

A number of new, practical case studies will leveragethe experience of others to demonstrate the impact ofcontainment on the planning, designing andconstruction of facilities. The successful validation offacilities and equipment, as well as “state-of-the-artadvances” will also be featured.

Learning ObjectivesAt 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 equipmentdesigns

• 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 yourissues 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

AgendaMonday, 28 November10.00 - 10.15 Welcome and IntroductionGiorgio de Castiglioni, Pharmatech Srl, ItalyJohannes Rauschnabel, Robert Bosch GmbH, Germany

10.15 - 11.15 Containment Issues from Design toConstructionGerald Cerulli, Technip Biopharm, USAJean François Dulière, Technip France, FranceFrancesco Zinnamosca, Technip Italy, Italy• Regulations in Europe and USA• Methodology, process design• Specification and equipment• Examples

11.15 - 12.15 Solids Containment for Filter DryersTorsten 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

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12.15 - 13.45 Lunch

13.45 - 14.45 Challenges and Innovation in Glove TestingJohannes Rauschnabel, Robert Bosch GmbH, Germany• 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 DesignGeert 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 toBarrier Isolation TechnologySpeaker to be advised• Impact of isolators from a regulatory perspective• Current international regulations for barrier isolation tech-

nology applied to pharmaceutical manufacturing and testing• Common GMP issues

17.15 - 17.45 Questions and Answers Session – Chair’sDay 1 CloseGiorgio de Castiglioni, Pharmatech Srl, ItalyJohannes Rauschnabel, Robert Bosch GmbH, Germany

17.45 - 19.30 Networking Reception

Tuesday, 29 November09.00 - 09.15 Recap of Day 1 – Introduction of Day 2Giorgio de Castiglioni, Pharmatech Srl, Italy

09.15 - 10.15 Containment Update on ISPE Baseline® GuidesISPE Representative invited• Bulk Pharmaceutical Chemicals Baseline Guide• Particulate measurement (SMEPAC)


10.45 - 11.45 Flexible Containment Systems forDischarge and FillingRichard 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 FlowOptimisation with ContainmentsAlois 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 forCompression and Tablet HandlingHarald 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

15.15 - 16.15 Questions and Answers Session – Chair’sConference CloseGiorgio de Castiglioni, Pharmatech Srl, ItalyJohannes Rauschnabel, Robert Bosch GmbH, Germany

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Conference Leaders

Gordon Farquharson, Bovis Lend Lease Technology, UK

Nunzio Genoni, Jacobs Italia SpA, Italy

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Sterile Product Processing for the 21st Century -

Conference DescriptionThis conference will first explore how FDA’s AsepticGuidance has bedded down, how it fits with theanticipated changes in Annex 1 (expected mid 2005)and the possible changes to the cleanroom standardISO 14644-1:1999. This standard is due for systematicreview in 2005.

Speakers will flesh out some of these requirements withpresentations of case studies and operationalexperience to help illustrate how the industry isinterpreting the guidance, and the real cGMPcompliance issues. Available technologies includingblow-fill-seal, RABS, isolators and particle counting willbe explored. The seminar will provide the opportunity fordiscussion of some key issues influencing operations inthe field of advanced aseptic processing and the impacton the business.

Learning ObjectivesAt 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

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

AgendaMonday, 28 November 10.00 - 10.15 Welcome and IntroductionGordon Farquharson, Bovis Lend Lease Technology, UKNunzio Genoni, Jacobs Italia SpA, Italy

10.15 - 11.00 FDA’s Aseptic Guidance (September 2004)– Industry View: 12 Months onSpeaker to be advised• 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 onSterile Product ProcessingJean-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 DraftJack Lysfjord, Valicare Division, Bosch, USAThe USA FDA has become increasingly concerned that theterm RABS is being used too loosely by our industry. FDAhas sought ISPE’s support to develop a consensus aboutthis 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 Fillingand Freeze Drying of Biopharmaceuticals – RABSTechnology Frank Küpler, Ferring, GermanyFreeze drying is an essential and growing technologyapplied to many biological products. The product andprocess is highly susceptible to contamination and theindustry 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

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Innovations, Guidelines and Regulatory Expectations


16.00 - 16.45 Operational and Business Impact whenIntroducing Isolation Technology in a ManufacturingFacilityPaul 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, developmentof 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 inIsolation Technology Speaker to be advised

17.30 - 17.45 Questions and Answers Session – Chair’sDay 1 CloseGordon Farquharson, Bovis Lend Lease Technology, UKNunzio Genoni, Jacobs Italia SpA, Italy


Tuesday, 29 November 09.00 - 09.10 Recap of Day 1 – Introduction of Day 2Gordon Farquharson, Bovis Lend Lease Technology, UKNunzio Genoni, Jacobs Italia SpA, Italy

09.10 - 10.00 Freeze Dryer Innovative Design forHandling Potent Drugs and/or Packaging Componentswith Critical CharacteristicsGerhard 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-LineNon-Contact Product Inspection with NMR – NewOpportunities and Challenges in Process ControlElena 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 Decontaminationwith VHP Maria Wingren, Ferring, Sweden

The evolution of sporicidal gassing of isolators has allowed thetechnique 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 inEU GMP Annex 1 on Environmental MonitoringGordon Farquharson, Bovis Lend Lease Technology, UK• 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 FacilitiesBaseline®® GuideISPE 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 – WorkshopPresentation

13.00 - 14.00 Lunch

14.00 - 15.30 Workshop: 21st Century Clean RoomTechnology ExpectationsOur industry has seen regulatory and technical developmentsover the last six to seven years that are unprecedented –isolators, ISO 14644 standards, the new FDA AsepticProcessing Guidance, etc. The status quo has shiftedenormously and presents challenges for everyone. Is the traditional “open cleanroom” technology an accep-table option? The following subjects will be explored in thisworkshop 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 teamleader.

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 cir-culation to all attendees

16.00 - 16.30 Questions and Answers – Chair’sConference CloseGordon Farquharson, Bovis Lend Lease Technology, UKNunzio Genoni, Jacobs Italia SpA, Italy

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Conference Leaders

Bob Lennon, Commissioning Agents, USA

Pietro Orombelli, Foster Wheeler, Italy

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Update on the Draft ISPE Maintenance Baseline ® Guide

Conference DescriptionThis Conference will provide an understanding of ISPE’sMaintenance Baseline® Guide that is currently indevelopment. The authors will present the philosophyand outline of the draft chapters of the Guide developedto date.

The Guide is a much awaited addition to the BaselinePharmaceutical Engineering Series as maintenanceoperations are becoming more critical to the operationsthat they support from a cost and regulatoryperspective. In particular maintenance departments arebeing asked to control costs whilst compliancerequirements are increasing.

Experiences will be shared through case studies bymaintenance professionals from major pharmaceuticalcompanies and suppliers.

The Maintenance Baseline Guide is currently indevelopment and is scheduled to be published in 2006.

Learning ObjectivesAt the conclusion of this conference, delegates will beable 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

Who Should Attend• Pharmaceutical maintenance professionals • Operating departments served by maintenance providers• Production personnel• Research and development staff• QA and compliance personnel

AgendaMonday, 28 November10.00 - 10.15 Welcome and IntroductionPietro Orombelli, Foster Wheeler, Italy

10.15 - 10.45 ISPE Maintenance Baseline GuidePhilosophy, Contents, and StatusPietro Orombelli, Foster Wheeler, Italy• 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 aSimulated AuditBob Lennon, Commissioning Agents, USAPietro Orombelli, Foster Wheeler, Italy• 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 PracticesDennis 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

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and Current Maintenance Approaches in Industry

13.45 - 14.30 Pharmaceutical Equipment Manufacturer’sPoint of View on Maintenance (Maintainability in theEquipment 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 Practicefrom a University ProfessorVittorio 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 HistoryBob Lennon, Commissioning Agents, USA• 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 MaintenanceRequirements as a Start to Implementing MaintenanceExcellence 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

17.00 - 17.45 Questions and Answers Session – Chair’sDay 1 CloseBob Lennon, Commissioning Agents, USA


Tuesday, 29 November09.00 - 09.15 Recap of Day 1 – Introduction of Day 2Bob Lennon, Commissioning Agents, USAPietro Orombelli, Foster Wheeler, Italy

09.15 - 10.00 Case Study: Improvement in theMaintenance 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 GMPProductionFrank 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 aRegulatory InspectorAudny Stenbraaten, Norwegian Inspection Agency, NorwayA 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 outBased on an Analytical ApproachTom 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 AspectsClaudio 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

16.30 - 17.15 Questions and Answers – Chair’sConference CloseBob Lennon, Commissioning Agents, USAPietro Orombelli, Foster Wheeler, Italy

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Conference Leaders

Sandro De Caris, IT Compliance Consultant, Italy

Hasse Greiner, Novo Nordisk A/S, Denmark

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Infrastructure: Validation, Compliance and Control in

Conference DescriptionDuring this course, delegates will be presented with acomplimentary copy of ISPE’s new GAMP® GoodPractice Guide: IT Infrastructure Control and Compliance. The new Guide facilitates global applications andservices, enabling the corporation to operate andcommunicate safely across internal and externalborders.

The course focuses on the dynamic nature of aninfrastructure and discusses the processes and types oftechnology deployed with emphasis on achieving andmaintaining control and compliance, taking advantageof the overall risk level and widespread controltechnology available.

The course discusses management processes forservers, clients and networks and the way they affect anorganisation’s choice of strategies for operation,security, compliance and control as well as the variousroles and responsibilities of the people involved.


• 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

Who Should Attend• Platform managers, infrastructure process managers,

subject matter experts • Information system managers • Technology managers• IT/IS validation and quality assurance subject matter

experts

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30 November 2005

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a Global IT Environment

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AgendaWednesday, 30 November10.00 - 10.15 Welcome and Introduction Sandro De Caris, IT Compliance Consultant, ItalyHasse Greiner, Novo Nordisk A/S, Denmark

10.15 - 11.15 The Regulatory PerspectiveSion 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 ComplianceHasse Greiner, Novo Nordisk A/S, Denmark• Special Interest Group (SIG) • Key concepts and terminology • Structure of the guide

12.45 - 14.15 Lunch

14.15 - 15.15 Network Qualification and ManagementYves 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 andManagementFinn 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 ITProblemDavid Stokes, MiServices Group, UK• Typical security issues • Technical risks and controls • Logical and physical security • People, processes and procedures

17.15 - 17.45 Questions and Answers – Chair’sConference Close Sandro De Caris, IT Compliance Consultant, ItalyHasse Greiner, Novo Nordisk A/S, Denmark


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Conference Leaders

Andrew Provan, Bovis Lend Lease, UK

Pier Giorgio Valeri, CTP Technologie di Processo, Italy

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AgendaWednesday, 30 November10.00 - 10.15 Welcome and Introduction Andrew Provan, Bovis Lend Lease, UKPier Giorgio Valeri, CTP Technologie di Processo, Italy

10.15 - 11.15 Regulatory ViewsSpeaker to be advised• What the inspector looks for• Documentation – Design• Documentation – Cleaning regime development• Examples of good practice

11.15 - 12.15 Selection of Cleaning DetergentsDerio 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 EquipmentAndrew Timperley, Campden and Chorleywood FoodResearch 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 FutureSpeaker to be advised • Principles for vessel and pipework cleaning• Instrumentation for maximum assurance• Minimising water usage and water recycling

Cleaning and Cleaning Validation

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30 November - 1 December 2005

Conference DescriptionThis Conference will provide an understanding of theregulations applicable to cleaning and its validation,cleaning objectives and acceptance criteria.

Presentations will cover current thinking on cleaningtechniques, and design of a plant for optimisingcleaning, practical examples of achieving validatedcleaning and some alternatives to the cleaning process.

The presentations should enable delegates toconfidently develop a compliant cleaning programmeappropriate to their circumstances.


• Describe FDA and European agency expectations forcleaning 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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17.15 - 17.45 Questions and Answers Session – Chair’sDay 1 CloseAndrew Provan, Bovis Lend Lease, UKPier Giorgio Valeri, CTP Technologie di Processo, Italy


Thursday, 1 December09.00 - 09.15 Recap of Day 1 – Introduction of Day 2Andrew Provan, Bovis Lend Lease, UKPier Giorgio Valeri, CTP Technologie di Processo, Italy

09.15 - 10.15 Case Study: Cleaning of Chemical APIMaterials 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 RecoveryMike 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 CaseStudyTim 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 ValidationGiuseppe Ceramelli, CTP CHEM, Italy• Typical installations• Selection of instruments• Calibrations• Case studies

15.15 - 16.15 Questions and Answers – Chair’sConference CloseAndrew Provan, Bovis Lend Lease, UKPier Giorgio Valeri, CTP Technologie di Processo, Italy

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Conference Leaders

David Selby, Selby Hope International, UK

Luca Vietry, CSV Life Science Srl, Italy

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Risk Management and ICHQ9

Conference DescriptionThe EU and FDA regulators’ recent introduction of theconcept of risk management into many aspects of GXPcompliance has caused the pharmaceutical industry totake a serious look at how it does business. ThisConference will provide an overview of the issuescommonly faced in a highly regulated industry anddemonstrate, though current examples, how theindustry is responding to the challenges arising from theintroduction of risk management.

This Conference will bring you up to date on the currentthinking for applying risk management in the highlyregulated pharmaceutical manufacturing arena,including an update on the ICH Q9 work and the FDA'sinitiative, “Pharmaceutical GMPs for the 21st Century - ARisk-Based Approach.” You'll also hear examples ofhow the FDA is approaching inspections and how therisk management concept will evolve into the future.

Additionally you will hear how companies have appliedthe concepts of risk management in their complianceactivities and also how other regulated industries makeuse 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

Who Should Attend• 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

AgendaWednesday, 30 November10.00 - 10.15 Welcome and Introduction David Selby, Selby Hope International, UKLuca Vietry, CSV Life Science Srl, Italy

10.15 - 11.15 FDA Regulatory Expectations with Regardto RiskSpeaker to be confirmed

11.15 - 12.15 European Regulatory Approach to RiskManagementSpeaker to be confirmed

12.15 - 13.30 Lunch

13.30 - 14.30 Risk Assessment – Lessons Learnt FromOther Industries 1 – Aerospace: Some AerospaceSpecificities and Trends Significant for a RiskAssessment ApproachAlain 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 sub-

contractors selection• Trends

• Risk becoming a major corporate management problem (reliability and failure impact results and market perception)

• Technical risk difficult to apprehend by topmanagement, creating strong demand for clear andoperative risk assessment tool

• Statistical risk assessment often irrelevant• Risk assessment must become deterministic and part of

decision making process

Program

me

30 November - 1 December 2005

15

• 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 ICHQ9David Selby, Selby Hope International, UK• 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 Studyfrom 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 MethodologyDavid Selby, Selby Hope International, UKSession description not available at time of printing

17.15 - 17.45 Question and Answer Session – Chair’sDay 1 CloseDavid Selby, Selby Hope International, UKLuca Vietry, CSV Life Science Srl, Italy


Thursday, 1 December 09.00 - 09.15 Recap of Day 1 – Introduction of Day 2Luca Vietry, CSV Life Science Srl, Italy

09.15 - 10.15 Risk Assessment GMP versus Health andSafetyLesley 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 Processin a Global R&D OrganisationHeather 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 Assessmentfor 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 aContainment Manufacturing FacilityGabriel Caciula, Pfizer, Global Quality Technical ServicesEurope, Belgium • Pfizer has recently applied the principles developed in the

ISPE Commissioning and Qualification Baseline® Guide tothe implementation of a tablet manufacturing project in Italy

• A number of challenges became obvious during theimplementation of the theory into practice

• The risk based approach contained in the system andcomponent level impact assessments proved a key factor inthe success of the project

• Lessons learned during the project were used to improvethe commissioning and qualification program to be appliedacross all Pfizer sites

15.15 - 15.45 Project Management and Informal RiskManagement for a SVP Dosage Forms Formulation andFilling Facility – The Case of Polpharma New AmpoulesDepartmentMarzio 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

15.45 - 16.15 Questions and Answers – Chair’sConference Close David Selby, Selby Hope International, UKLuca Vietry, CSV Life Science Srl, Italy

Program

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Conference Leaders

Sandro De Caris, IT Compliance Consultant, Italy

Randy Perez, Novartis, USA

16

Conference DescriptionDuring this course, delegates will be presented with acomplimentary copy of ISPE’s new GAMP® Good PracticeGuide: Global Information Systems Control andCompliance. The new Guide describes global informationsystem life cycle management in light of diverse localregulations.

The course discusses some system architectures and theway they affect an organisation's choice of projectstrategies for development, validation and operation.

It will also address strategies for establishing the mostefficient system management and data managementprocesses for a global system to ensure it remains in avalidated state.


• 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

Program

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1 December 2005

Global Information Systems: Validation, Compliance and

STST


17

AgendaThursday, 1 December 200509.00 - 09.30 Welcome and Introduction: SIGBackground and Document OverviewRandy Perez, Novartis, USA• Problem statement• Challenges and opportunities

09.30 - 10.30 Handling International Differences, fromRegulatory Issues to Corporate CultureWinnie 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 Sandro De Caris, IT Compliance Consultant, Italy• System ownership• Leveraging resources• Coordinating reporting• Documentation management

12.00 - 13.00 Planning Test and Managing GlobalTesting 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 Randy Perez, Novartis, USA• Global change control • Global configuration management• Security management• Optimising and retaining the value of data

15.00 - 15.30 Case Study: Applying Global InformationSystems - Control and Compliance Principles inCentral 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 DrugSafety 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 forControl Design and Plant Data Integration in the cGMPAutomated Plant for API ProductionMarco Banti, ABB PS&S, Italy• The impact of S88 Standard in designing a URS for a

common architecture from process control operationand 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, manufacturingoperation and plant asset optimisation

• How to define clear project task responsibilities, defineIQ/OQ issues and meet 21 CFR Part 11 requirements

17.00 - 17.30 Questions and Answers – Chair’sConference CloseRandy Perez, Novartis, USASandro De Caris, IT Compliance Consultant, Italy

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Control in a Global IT Environment STST

18

General

Inform

atio

n

General Information

VenueMilan Marriott HotelVia Washington 66I-20146 Milan, ItalyTel: +39-0248521Fax: +39-024818925www.marriotthotels.com

DescriptionThe five-star Milan Marriott Hotel is located on ViaWashington within a few minutes of the InternationalFair Grounds. The hotel provides daily shuttles ascourtesy for the guests and is located nearbyprestigious 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 dialtelephone with voice mail, telephone in bathroom andservices the discriminating traveller is accustomed to.Guests can access the fitness room, the boutique andthe business centre. La Brasserie de Milan restaurantfeatures an open view kitchen, for the best regionaland Mediterranean cuisine.

AccommodationA block of rooms has been reserved at the MilanMarriott Hotel for conference participants, at thepreferential rate of €160 for a single room and €180 fora double room (including breakfast and taxes). This offeris limited and we encourage you to register as early aspossible.

To book your accommodation at the Milan MarriottHotel, please send your accommodation reservationrequest together with your conference registration toISPE Registration Services (fax: +32-2-743 1584).Reservations cannot be processed and guaranteedwithout a credit card number.

Accommodation and any extras are to be settled byeach delegate directly with the hotel upon check-out.Changes in bookings or cancellations are accepted onlyin writing directly to ISPE Registration Services prior tothe event and no later than 10 November 2005. Thehotel is entitled to charge the entire value of the room

reservation in case of cancellations received later than48 hours before arrival.

Other hotel options are at your own arrangements.

BadgesName badge must be worn at all times. Delegates notwearing their badges will be denied entrance toconferences.

TransportationThere are two international airports in Milan:Malpensa is 50 km away from the Marriott Hotel. A busservice is available from the airport to the hotel, atapproximately € 6 (one way). Please note that this is nota service operated by the Marriott Hotel. The estimatedtaxi fare from the airport to the hotel is approximately€ 80 (one way). You can also use Malpensa ExpressTrains (departure from Terminal 1) to reach the centralstation. From there, take the subway to “Wagner”(approximately five minutes walk to the hotel).

Linate is 20 km away from the Marriott Hotel. A busservice is available from the airport to the hotel, atapproximately € 3 (one way). Please note that this is nota service operated by the Marriott Hotel. The estimatedtaxi fare from the airport to the hotel is approximately€ 40 (one way).

ISPE Registration Desk HoursThe ISPE Registration Desk will be open during thefollowing time:

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 CodeBusiness Casual.

® Baseline and GAMP are registered trademarks of ISPE

19

Netw

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pportunit

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Networking Receptions(Monday, 28 November and Wednesday, 30 November)

These two receptions, at the Marriott Hotel, are an excellentopportunity to meet with exhibitors and learn about theirnewest technologies in a fun and casual environment. Enjoyfood and drinks with your colleagues!

Lunches and Coffee BreaksEnjoy a complimentary lunch to gear up for the afternoon’sactivities. A hot cup of coffee or tea in the exhibition areawill offer you a well-deserved break in a busy day.

Mark Your Calendar!

■ ISPE Copenhagen Conferences24-27 April 2006Marriott Hotel Copenhagen, Denmark

■ ISPE Vienna Congress18-22 September 2006International Hotel Vienna, Austria

■ ISPE Brussels Conferences4-7 December 2006Sheraton Hotel and Towers Brussels, Belgium

For more information contact: [email protected]

or visit: www.ispe.org/GlobalCalendar

ISPE Italy AffiliateSocial Evening

Monday, 28 November

A taste of Milanese specialities and Italian wines in oneof the city’s most elegant ancient Museums.

Milan has been considered one of the most fascinatingcities in the world, due to its canals, called "Navigli". Inthe ancient atmosphere of Museo dei Navigli, ISPE’sItalian Affiliate will organise a cocktail reception followedby a Milanese dinner.

On the way to Museo dei Navigli, you will be able tobriefly enjoy some of Milan’s most impressive sites,passing nearby Castello Sforzesco, the magnificentPiazza del Duomo and La Scala, Italy’s world famoustheatre.

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 specialitiesand Italian wines

22.30 Departure by bus from Museo dei Navigli

22.45 Arrival at the Marriott Hotel

Experience the elegance of Milan’s monuments and gastronomic specialities. If you wish to attend thisevent, please tick the appropriate box in the registrationform. The cost per person is € 60. Places are limited.

Networking Opportunities

20

Table

Top and S

ponsorship

O

pportunit

ies

Table Top Exhibits and Sponsorship Opportunities

Sponsorship OpportunitiesISPE offers high-visibility, low-cost exclusive sponsorshipopportunities for suppliers to the global healthcaremanufacturing industry.

• A literature display table near the food/beveragefunction 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 isbooked on time

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

• Company logo displayed on signs at food/beveragefunctions

• Sponsor ribbons for all company employees in attendance

To book your sponsorship, please contact:

Françoise RajewskiEuropean Sales Manager

Tel: + 32-2-743 1581 / Fax: +32-2-743 1578E-mail: [email protected]

Table Top ExhibitsISPE offers companies the opportunity to present their products face-to-face with potential customers in aninformal atmosphere in conjunction with the ISPE MilanConferences.

Morning and afternoon refreshments are served in theexhibition area to attract the maximum number ofconference 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 VanpeteghemEuropean Events Logistics Coordinator

Tel: +32-2-743 4422 / Fax: +32-2-743 1584E-mail: [email protected]


List of ExhibitorsBOC EdwardsCrane Process Flow Technologies Ltd.CPS ExtactEntegrisEreaFoster WheelerHecht Anlagenbau GmbHHoneywellHoworth Airtech Ltd.Isolation Solutions SAMRO SoftwareNNENovasepticPharmaduleSAE-STAHL GmbH

For an updated list of Exhitors, visit www.ispe.org/GoTo_MilanConferences

Registration FeesConferences registration fees include:• Conference material• Refreshment breaks• Lunches• Networking Reception• Exhibit hall access

If you have registered as a nonmember, you are entitled toa complimentary one-year membership in ISPE. To receivean ISPE membership application form, please tick the boxon the registration form. Your membership application mustbe returned to ISPE within 30 days in order to activate yourmembership.

ISPE membership is individual and must be paid in full toqualify for the Member fee. If you have questions regardingyour membership status, please contact ISPE by tel: + 32-2-743 4422 or fax: + 32-2-743 1584.

PaymentPayment must accompany registration form. Registrationwill not be processed nor confirmed without payment inEuro (€). All registrations sent by fax must include thenecessary payment information. American Express, Visa orEC/MasterCard is accepted. Please complete theappropriate spaces and sign the registration form.

Early Registration Deadline To benefit from the early registration deadline, paymentmust be received before 14 October 2005. After this date,you will be charged the standard registration fee.

ConfirmationUpon receipt of payment, a proof of payment will be sentto you, along with your confirmation letter (time permitting).Hotel accommodation is not included in the registration fee.Please present your registration confirmation letter at theISPE Registration Desk at the Milan Marriott Hotel. You willreceive your Conference materials and personal namebadge.

If you do not receive your confirmation letter, pleasecontact ISPE at:

ISPE Registration ServicesAvenue de Tervueren, 300B-1150 BrusselsBelgiumTel: + 32-2-743 4422Fax: + 32-2-743 1584E-mail: [email protected]

In order to be listed in the official delegate roster, you mustbe registered and paid by 18 November 2005.

Cancellation PoliciesFull refunds, less a handling fee of € 100 per registrant, willbe granted to requests received in writing before or on 10 November 2005. No refunds will be granted for requestsreceived after 10 November 2005. Telephone cancellationswill not be accepted.

LiabilityIn case of Government intervention or regulation, militaryactivity, strikes or any other circumstances that make itimpossible or inadvisable for the ISPE Milan Conferencesto take place at the time and place provided, theparticipant shall waive any claim for damages orcompensation except the amount paid for registration afterdeduction of actual expenses incurred in connection withthe Conferences and there shall be no future liability on thepart of either party.

SubstitutionsIf a delegate is unable to attend, substitutions will beaccepted; however, nonmembers substituting forMembers must pay the difference in fees prior to the startof the event. ISPE can not be held responsible for lostairfare due to cancellations.

ISPE NoticeThe speakers invited to present ISPE’s programmes areleading professionals in their field. Should it be necessary,substitutions may be made. Every precaution is taken toensure accuracy, but ISPE cannot accept responsibility forthe accuracy of information distributed or contained inthese programmes, or for any other opinion expressed.

Group DiscountsGroup of Two Save 10%: Two participants from the samecompany location attending conferences at a single venuesave 10% on the registration fees.Group of Three or More Save 15%: Three participants fromthe same company location attending conferences at asingle venue save 15% on the registration fees.

Discounts cannot be combined and Member andnonmember pricing applies. Team registrations must besubmitted at the same time. Substitutions will beaccepted.Please contact ISPE Registration Services to receive aGroup Discount Registration Form or visit:www.ispe.org/GoTo_MilanConferences.

Emerging Economy Countries Discount

ISPE is offering 25% discount on the registration fee toMembers from Emerging Economy countries. To review thelist of eligible countries visit:www.ispe.org/EmergingEconomyList.The discount will automatically apply when registration isprocessed.

Registration and Cancellation Policies

Registration Form ISPE Milan ConferencesI. Delegate Information 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.

II. Conferences RegistrationPlease select the conference you wish to attend (one conference per two-day event)..Prices below do NOT include VAT.

* 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, whichmust be returned to ISPE within 30 days in order to aaccttiivvaattee yyoouurr mmeemmbbeerrsshhiipp.

❐ 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 2200 %% IIttaalliiaann VVAATT iiss aapppplliiccaabbllee.. RReeggiissttrraattiioonnss wwiillll nnoott bbee aacccceepptteedd wwiitthhoouutt ppaayymmeenntt..

Sub-Total: €ISPE Italy Affiliate Social Evening x € 60 €20 % VAT: €TOTAL DUE: €

❐ Credit Card: ❐ AMEX ❐ VISA ❐ EC/MasterCardCredit Card number: Expiry Date:Cardholder’s name: Signature:

V. Special Needs (dietary):VI. Hotel ReservationPlease 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. SignatureBy signing, I agree with the ISPE Registration and Cancellation Policies (see page 21).Date: Signature:

MilConf2

Please return to:

ISPE Registration Services

Avenue de Tervueren, 300

B-1150 Brussels

Belgium

Tel: +32-2-743 4422

Fax: +32-2-743 1584

Payment received on or before 14 October

❐ FFuullll CCoonnffeerreennccee ((2288 NNoovveemmbbeerr -- 11 DDeecceemmbbeerr)).. Please select below the conferences you will be attending (one conference per two-day event) € 1540 € 1890 € 1990 € 2340 € 200 € 230 € 1020

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

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

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

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

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

2288--2299 NNoovveemmbbeerr 22000055❐ Containment Technology Forum

❐ Sterile Product Processing for the 21st Century

❐ Update on the Draft ISPE Maintenance Baseline® Guide and CurrentMaintenance Approaches in Industry

3300 NNoovveemmbbeerr ❐ Infrastructure: Validation, Compliance and Control in a Global IT Environment

3300 NNoovveemmbbeerr -- 11 DDeecceemmbbeerr ❐ Cleaning and Cleaning Validation

❐ Risk Management and ICHQ9

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

Member Nonmember*

Payment received after 14 October

Member Nonmember*

Student**

Member Nonmember

Government/Faculty

STST

STST

STST

ISPE European OfficeAvenue de Tervueren, 300

B-1150 BrusselsBelgium

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

E-mail: [email protected]

www.ispe.org

Engineering Pharmaceutical Innovation

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