3165 ispe barcelona conf 2:x - its · pdf filegamp ® guide achieving ... and hvac systems...
TRANSCRIPT
www.ISPE.org/barcelonaconference
ISPEApplying a Science and Risk-based Approach
1 – 4 December 2008Hotel Rey Juan Carlos I, Barcelona, Spain
Barcelona Conference on
ISPE offers pharmaceutical scientists and engineers, industry specialists and
management professionals a comprehensive conference programme on one of
the industry’s hottest topics - managing risk. Participate in your choice of six
seminar sessions including regulatory insights, industry best practice,
updates on key ISPE publications, case studies and workshops.
Full Conference Programme Ea
rly
Bir
d D
eadl
ine:
24
Oct
ober
200
8
■ Successful Management of Sterile ProductsQuality – Including Review of the Updated Baseline® Guide
for Sterile Products and Processes
■ Applied Risk Management – Addressing Cross
Industry Challenges
■ Achieving Operational Excellence in Biomanufacturing – Trends and Case Studies
■ Containment Technology Forum – Applying ICH
Q9 Principles to Selecting Containment Technology and
Including an Introduction to ISPE’s Risk-MaPP Baseline® Guide
■ Validation of Process Control Systems – A Major
Revision of the GAMP® Guide
■ Lyophilisation – Scientific Issues of the Process and Introduction
to a Risk-based Approach
3
Next European Event: ISPE Brussels Conference on EnhancedCompetitiveness – Sustainable Achievement
30 March – 2 April 2009: Brussels, Belgiumwww.ISPE.org/brusselsconference
Join ISPE Today! 25,000 pharmaceutical industry professionals in 90 countries have chosen
to join ISPE’s vibrant community and share the benefits of:
• Networking – Meet and greet peers from around the world through
global education programmes, as well as local Affiliate and Chapter
meetings
• Resources – Member-only content on ISPE’s comprehensive Web site,
publications such as Pharmaceutical Engineering and the Journal of
Pharmaceutical Innovation and career opportunities
• Savings – Discounts on ISPE educational events, local Affiliate and
Chapter activities and ISPE publications
Visit www.ISPE.org to learn more about ISPE membership and benefits
available to you when you join.
® The ISPE logo, tagline, GAMP and Baseline are registered trademarks of ISPE.
2008 Barcelona Conference2008 Barcelona Conference
ContentProgramme-at-a-Glance ........................................... 3
Conference Programme............................................ 4
Networking Information ......................................... 16
General Information ............................................... 17
Exhibition and Sponsorship Opportunities .............. 18
Registration and Cancellation Policies .................... 19
Registration Form .................................................. 20
Successful Management
of Sterile ProductsQuality
Containment Technology Forum: Applying ICH Q9
Principles to SelectingContainmentTechnology
Monday 1 December
Tuesday 2 December
Wednesday 3 December
Thursday 4 December
Applied Risk Management –
Addressing Cross Industry Challenges
Validation of ProcessControl Systems – A
Major Revision of theGAMP® Guide
Achieving OperationalExcellence in
Biomanufacturing:Trends and Case Studies
Lyophilisation: Scientific Issues of the
Process and Introduction to
Risk-based Approach
Networking Reception17.30 – 18.30 and Conference
Networking Social Evening
Networking Reception17.30 – 18.30
Date Conference Sessions Networking/Social Events
Programme-At-A-Glance
✓ Regulators views on risk management – speakers from
FDA and MHRA
✓ Advice and support on EU GMP Annex 1: 2008
✓ Outline of the updated ISPE Baseline® Guide for Sterile
Products and Processes
This seminar will provide the latest information in the sterile
manufacturing arena on best practices used to manage
quality of product for patient safety.
An update on current European and FDA Good Manufacturing
Practice (GMP) Regulations will be given, with discussion on
the implementation of Annex 1, and ISO guidelines in the area
of healthcare products.
Through a series of seminar sessions, updates, discussions and
workshops, this seminar will address risk assessment issues,
best practices for new regulation and technology, regulatory
updates, project facility issues associated with refurbishment,
new technologies and barrier systems. The updated ISPE
Baseline® Guide for Sterile Products and Processes will also be
discussed, alongside updates from recent events and through
expert speakers on this important topic.
Speakers include regulators from FDA and MHRA, plus industry
leaders and professionals active in handling sterile products.
Take Back To Your Job
• A regulatory update on sterile products and risk management
issues – including views from regulators
• An understanding of risk – how it is defined, managed and
assessed
• Gain knowledge on the latest technological developments
and practices
• Insight on facility conversion considerations
• Case studies based on experience, best practices and current
regulation
• Updates from a range of important resources, including
regulators, expert speakers and a round up from other recent
events
Agenda
Monday, 1 December
10.00 – 10.15 Welcome and IntroductionLynn Bryan, Ballygan Consulting (UK); Rob Walker,
GMP Consultancy Ltd (UK)
10.15 – 11.00 Annex 1 Issues and Evolving PracticeGordon Farquharson, Bovis Lend Lease
Pharmaceutical (UK)
• Background on the publication of the February
2008 revision
• Review of the essential changes
• EMEA responses to industry concerns and
questions
• Impact of changes to classification of clean zones
and airborne particle monitoring
• Implementing the new vial capping and over-
sealing requirements
11.00 – 11.45 Review of the updated
Bruce Davis, AstraZeneca (UK)
• Session updates available online, visit
www.ISPE.org/barcelonaconference
11.45 – 12.30 Risk Assessment with Regard to Sterile
ProductsRob Walker on behalf of Tim Eaton, AstraZeneca
(UK)
• Session updates available online, visit
www.ISPE.org/barcelonaconference
for Sterile Products and Processes
Baseline® Guide
Successful Management of Sterile Products Quality
1 – 2 December 2008
Seminar Leaders:Lynn Bryan, Ballygan Consulting (UK); Rob Walker, GMP Consultancy Ltd (UK)
▼
4www.ISPE.org/barcelonaconference
13.45 – 14.40 EU GMP Annex 1: 2008 and Non Viable
Particle CountingTim Russell, Facility Monitoring Systems Ltd (UK)
• Cleanliness classification and process monitoring –
what is the difference?
• New 5µm limits and sample frequency
• Considerations when selecting manifolds or point-
of-use particle counters
• Understanding the data: How a monitoring
system can be used to detect contamination
events
14.40 – 15.35 Media Fill IssuesDeclan Quinlan, Genzyme (Ireland)
• Meeting regulatory expectations for process
simulation testing
• Organise materials and personnel in launching the
media fill
• Design of a media fill study for form-fill and
lyophilisation operations
• Overcome common challenges and difficulties in
developing a process simulation
• Determine the correct sample size and statistical
approach for your media fill
• Determine the technical limitations of media fills
• Identification of the potential weaknesses of your
aseptic operation which might contribute to the
microbiological contamination of the product
15.35 – 16.15 Questions and Answers, Close of SeminarLynn Bryan, Ballygan Consulting (UK); Rob Walker,
GMP Consultancy Ltd (UK)
12.30 – 13.45 Lunch and Networking Break
13.45 – 14.30 FDA View on Risk ManagementSpeaker to be confirmed
• Session updates available online, visit
www.ISPE.org/barcelonaconference
14.30 – 15.15 MHRA View on Risk ManagementPaul Hargreaves, MHRA (UK)
• Session updates available online, visit
www.ISPE.org/barcelonaconference
15.15 – 15.45 Coffee and Networking Break
15.45 – 17.30 Workshop A: Environmental Monitoring
Workshop B: Risk ManagementLynn Bryan, Ballygan Consulting (UK); Rob Walker,
GMP Consultancy Ltd (UK)
17.30 – 17.45 Questions and Answers, Close of Day 1Lynn Bryan, Ballygan Consulting (UK); Rob Walker,
GMP Consultancy Ltd (UK)
17.30 – 18.30 Networking Reception
Tuesday, 2 December
09.00 – 09.15 Review of Day 1, Introduction to Day 2Lynn Bryan, Ballygan Consulting (UK); Rob Walker,
GMP Consultancy Ltd (UK)
09.15 – 10.05 Sterile and Safe - Barrier Systems for Product
and Operator ProtectionJohannes Rauschnabel, Bosch Packaging
Technology (Germany); Mathias Kreher, Bosch
Packaging Technology (Germany)
• Definitions and borderlines
• Sterility
• Air management
• Transfers
• Case studies (compounding, filling and
lyo-loading)
10.05 – 10.35 Coffee and Networking Break
10.35 – 11.25 The Impact of Disposable Technologies on
Sterile ProcessingMiriam Monge, Biopharm Services Ltd (UK); Jörg
Zimmerman, Vetter Pharmaceuticals (Germany)
• Where are disposable technologies most used in
sterile processing through to final filling?
• What are the advantages/disadvantages?
• Latest technology innovations
• End-user case studies
11.25 – 12.15 Challenges in Facility Conversion: A Case
Study for a Sterile Facility John Seagrief, 5pharma (UK)
• Establishing constraints of the existing building
and HVAC systems
• Designing a new facility to incorporate sterile
requirements and maximise opportunities
• Cost and energy-saving approaches
• Progress through the facility build to functional
sterile suite
12.15 – 13.45 Lunch and Networking Break
5www.ISPE.org/barcelonaconference
6www.ISPE.org/barcelonaconference
✓ Thorough overview of risk management issues – covering
many aspects of the pharmaceutical product lifecycle
✓ An introduction to ISPE’s new Risk-MaPP Baseline® Guide
✓ A take-home "tool kit" of useful techniques, concepts
and case studies
Risk management is a process used within most areas of the
pharmaceutical and biopharmaceutical industry - whether it is
assessing the risks in developing or manufacturing a new drug,
or the risks when building facilities to produce drugs. Within
the pharmaceutical industry, a vast array of potential risks need
to be identified, eliminated or mitigated - and ultimately
controlled. Our goal is to take a risk-based approach to all
aspects of the drug product lifecycle: from development to
launch; from launch to sustainable manufacture.
This seminar will introduce general principles of risk
management which are applicable across the industry and
aims to be a practical workshop introducing different risk types
and challenges, including quality (ICH Q9); project (cost, time
and scope risks); operational (risks associated with health and
safety, containment, maintenance and quality); business
(supply chain, commercial and competitive risks).
Speakers include leaders in the field of risk management, and
subject matter experts from ISPE Communities of Practice
(COPs). During interactive sessions, speakers will present
concepts, tools and case studies and offer hands-on practice in
applying these.
Take Back To Your Job
• Familiarity with the generic concepts of risk management
applicable in all areas of risk assessment – from quality to
safety
• The ability to apply generic risk management concepts
and tools – introduced and explained during the seminar
• A take-home "tool kit" for risk management – including
tools, techniques, templates and sample model answers
Agenda
Monday, 1 December
10.00 – 10.05 Welcome and IntroductionTrish Melton, MIME Solutions (UK)
10.05 – 11.00 A Risk-based Approach to the
Pharmaceutical Product LifecycleDamian Greene, Pfizer (tbc)
• Broad overview of the risks at each stage in the
product lifecycle from product development
through launch to sustainable supply
• The strategic importance of risk management to
our industry and to our business
11.00 – 11.45 Quality Risk Challenges – An Overview of
ICH Q9Malcolm Holmes, Retired (UK)
• An overview of ICH Q9 and why this is needed
within our industry: The history and the benefits
• Quality risk assessment: The process, key
principles and examples of tool use in specific
scenarios within the pharmaceutical industry
11.45 – 12.30 Risk Management Techniques –
An IntroductionTrish Melton, MIME Solutions (UK)
• An introduction to generic risk management –
process and principles
• The introduction of some generic tools and
techniques and when each can be used, e.g., risk
matrices and decision tools, FMEA, Ishikawa,
HACCP, etc
• Delegates will have an opportunity to complete a
brief exercise using a ‘what if’ risk technique
12.30 – 14.00 Lunch and Networking Break
14.00 – 15.30 Project Risk ManagementJim Durkin, Advanced Medical Solutions (UK)
• Introduction to typical cost, time and scope risks
• Interaction with other functions and links to
business risk
Applied Risk Management - AddressingCross Industry Challenges
1 – 2 December 2008
Seminar Leaders:Trish Melton, MIME Solutions Ltd (UK); Jörg Block, Bayer Healthcare AG (Germany)
▼
7
• The application of SWOT analysis and the risk
table and Matrix in a project situation
• Introduction of a case study and tool template
which delegates will use to address project risks
15.30 – 16.00 Coffee and Networking Break
16.00 – 17.30 Containment Risk Assessment –
Malcolm Holmes, Retired (UK)
• An introduction to ISPE’s new Risk-MaPP
Baseline® Guide
• Introduction to holistic approach to management
of risks presented to patient/operator from
pharmaceutical compounds handled in a
pharmaceutical manufacturing environment
• Introducing some of the tools such as process
mapping, cause and effect diagrams, logic
diagrams and HAZOP and how these assist in
managing exposure risks
• Introduction of a case study and tool template
which delegates will use to address exposure risks
17.30 – 17.45 Questions and Answers, Close of Day 1Trish Melton, MIME Solutions (UK); Jörg Block,
Bayer HealthCare AG (Germany)
17.30 – 18.30 Networking Reception
Tuesday, 2 December
09.00 – 09.15 Review of Day 1, Introduction to Day 2Jörg Block, Bayer HealthCare AG (Germany)
Baseline® Guide
Risk-MaPP
www.ISPE.org/barcelonaconference
• The application of risk checklists on a fault tree
basis
• Introduction of a case study and tool template for
diversified software systems
15.00 – 16.15 An Approach to Risk Management in API
Facility DesignJohn Nichols, Retired (UK)
• An introduction to the risk management approach
outlined in the revised API Baseline® Guide
(launched in June 2007)
• Using risk flow charts and associated checklists to
define critical parameters and levels of protection
• Introducing two additional risk techniques to
support the assessment of ‘briefly open’ to
address exposure risks from a quality perspective –
FMEA and HACCP
• Introduction of a case study and tool template
which delegates will use to address the risks of an
exposed API operation
16.15 – 16.40 Risk Management Master ClassAll speakers of days 1 and 2, chaired by Trish
Melton, MIME Solutions (UK)
• An opportunity for the delegates to ask the
experts about specific risk management issues
16.40 – 16.45 Questions and Answers, Close of SeminarJörg Block, Bayer HealthCare AG (Germany);
Trish Melton, MIME Solutions (UK)
09.15 – 10.45 Risk Management in the Manufacturing
LifecycleRoberto Correa, Bayer HealthCare (Germany)
• Introduction to the risks in manufacturing
operation and maintenance – safety, quality and
business
• Application of the ICH Q9 risk management
process to quality, safety and business risks using a
simplified FMEA approach
• Introduction of a case study and tool template
which delegates will use to review manufacturing
risks
10.45 – 11.00 Coffee and Networking Break
11.00 – 12.30 The Risk-based Approach in Commissioning
and Qualification (C&Q)Jörg Block, Bayer HealthCare AG (Germany)
• Introduction of C&Q in terms of its approach to
risk management and how techniques such as
HACCP and Ishikawa analysis can be used
• Introduction of a case study and tool template
which delegates will use to address the critical
aspects of C&Q
12.30 – 13.30 Lunch and Networking Break
13.30 – 15.00 Efficient Risk Assessment for Computer
Systems using Hartmut Hensel, Fachhochschule Harz (Germany)
• Application of the GAMP® 5 risk management
process for initial system risk assessment
considering the software impact on product quality
GAMP® 5
8www.ISPE.org/barcelonaconference
✓ Technical presentations, advice and experience from industry
leaders, including updates on current regulatory requirements
✓ Take-home case studies on key issues and hot topics
✓ Insight into new technologies, concepts and ideas
The biopharmaceutical industry has grown rapidly over the lastdecade. This seminar will consider how to achieve operationaleffectiveness and will consider key issues such as the impact ofdisposable technology, flexible operation, fast turnaround and costimplications. Practical techniques such as high titer cell culture, bio separation,DSP, continuous chromatography and aseptic fill and finish will bediscussed alongside the strategic, operational and economic issuesinvolved in their use. Including sessions on waste management and treatment, facilities,lean design, and the global hot topic – sustainability - the seminarspeakers include technical experts and leaders in biomanufacturinginnovations. Using workshops, case studies and models to present concepts anddiscussions points, the speakers will take a global perspective onthe issues involved in balancing more efficient and cost-effectiveprocesses, achieving higher returns on investment, improvingscience and technology and current regulatory requirements.
Achieving Operational Excellence in Biomanufacturing: Trends and Case Studies
1 – 2 December 2008
Seminar Leaders:Miriam Monge, Biopharm Services (France); Dirk Boehm, Merck Serono (Switzerland)
▼
Take Back to Your Job
• Stay current with the latest technologies and trends
• Learn about new tools, approaches and best practice to support
lean manufacturing
• Update on current regulatory requirements in biomanufacturing
• Benefit from peer learning in workshops and discussions
Agenda
Monday, 1 December
10.00 – 10.15 Welcome and IntroductionMiriam Monge, Biopharm Services (France);
Dirk Boehm, Merck Serono (Switzerland)
10.15 – 10.55 The Facility of the FutureJohannes Roebers, Elan (Ireland)
• The history and future of biotechnology
manufacturing
• Improvements in traditional manufacturing systems
• Novel and single-use manufacturing systems
• Comparison of systems and trends in
manufacturing
10.55 – 11.35 Disposables Revolutionising Biomanufacturing?Miriam Monge, Biopharm Services (France)
• Implications of implementing the disposable project
• Integrating design and procurement strategies
• Reducing risk and managing the supply chain
11.35 – 12.15 The Appropriateness of Disposable
Technology: Lessons from Big PharmaTom Erdenberger, Wyeth Biotech Technology &
Engineering (USA)
• Multi-product in campaigns vs. single-product
for long term
• Case study: Retrofit vs. new build
12.15 – 12.20 Questions and AnswersSpeaker to be confirmed
• Session updates available online, visit
www.ISPE.org/barcelonaconference
12.20 – 13.20 Lunch and Networking Break
13.20 – 14.00 Reducing Capital and Operating Costs in
Biomanufacturing: The Role of Modelling ToolsAndrew Sinclair, Biopharm Services (UK)
• Challenges of driving out costs
• How do models provide insights to cost
contributors within processes
• Using cost models to set targets for lean
manufacturing
• Examining the use of cost modelling in practice
14.00 – 14.40 High Titer Cell Culture Using the Per C6 Cell LineRobert Hof, DSM Biologics (Netherlands)
• Extreme density cell culture; process design and
benefits
• High titer cell culture; holistic view on manufacturing
• Disposable technologies
• Potential manufacturing strategies
14.40 – 15.20 Operational, Economic and Strategic Analysis of
the Single-use Bioreactor (SUB)Eric Isberg, Hyclone (USA)
• Overview of SUB technology
• Comparing stainless steel and SUB using advanced
system analysis
9www.ISPE.org/barcelonaconference
• Summary of SUB implementation case studies
• Future technologies and strategies
15.20 – 15.40 Coffee and Networking Break
15.40 – 16.20 Hot Topics in Bioseparation: Bottlenecks,
Obstacles and SolutionsUwe Gottschalk, Sartorius (Germany)
• The role of biochromatography in downstream
processing
• Streamlining of operations
• The role of emerging technologies
• The use of disposables
16.20 – 17.00 Strategies to Achieve Operational Excellence in DSPManuel Nyffeler, GE Healthcare (Sweden)
• Session updates available online, visit
www.ISPE.org/barcelonaconference
17.00 – 17.15 Questions and Answers, Close of Day 1Miriam Monge, Biopharm Services (France);
Dirk Boehm, Merck Serono (Switzerland)
17.30 – 18.30 Networking Reception
Tuesday, 2 December
08.30 – 08.45 Review of Day 1, Introduction to Day 2Miriam Monge, Biopharm Services (France);
Dirk Boehm, Merck Serono (Switzerland)
08.45 – 09.25 MCSGP: Continuous Chromatography in
BioseparationThomas Müller-Späth, ETH Zurich, Institute of
Chemistry and Bioengineering (Switzerland)
• Concept of continuous chromatography and
the working principle of MCSGP
• Comparison of a single column batch process
and continuous MCSGP
• Case study: Comparison of a cation-exchange
MCSGP and batch Protein A affinity
chromatography
09.25 – 10.05 Aseptic Fill and Finish Operations:
Making the Right Technical and Commercial
Decisions for Your ProductJörg Zimmermann, Vetter Pharmaceuticals
(Germany)
• Make or buy decision for new production lines
• Aseptic process designs: RABS and isolators
• The use of disposables
• Options for storage and transport for bulk product
10.05 – 10.35 Coffee and Networking Break
10.35 – 11.20 Leveraging Knowledge Management Techniques
to Achieve Operation Excellence from Bioprocess
Development to BiomanufacturingBruce Williams, Avecia (UK)
• Setting up data structures for process transfer
• Benefits and challenges of consolidating islands of
data
• Case study: Development of a knowledge
management model for biopharmaceuticals
11.20 – 12.00 State-of-the-art Media Development and Impact
on Process Development and ManufacturingMartin Jordan, Merck Serono (Switzerland)
• Achieving operational excellence through
establishing a generic platform to develop and
optimise chemically defined media based on
a scale down disposable culture technology
• Balancing of key components to achieve an
efficient medium
• Ensuring a robust process by maintaining
components within the desired range throughout
the whole production phase
12.00 – 12.15 Questions and AnswersMiriam Monge, Biopharm Services (France);
Dirk Boehm, Merck Serono (Switzerland)
12.15 – 13.30 Lunch and Networking Break
13.30 – 14.15 Sustainability: Environmental and Waste
Water Treatment Influences on New Process
Development and Biomanufacturing Dirk Boehm, Merck Serono (Switzerland)
• Environmental impact and process development
• Environmental impact and product lifecycle
• Environmental impact and facility design
14.15 – 15.45 Workshops Speakers of day 1 and day 2
• More effective purification (increasing
effectiveness)
• Understanding cost tools and approaches
• Sustainability and environmental impact
• Implications of disposables technologies;
where will this go?
15.45 – 16.30 Group Presentations and Close of SeminarMiriam Monge, Biopharm Services (France);
Dirk Boehm, Merck Serono (Switzerland)
10www.ISPE.org/barcelonaconference
✓ Develop successful solutions to current containment issues
✓ Consider assessment tools such as ICH Q9 and the new
ISPE Risk-MaPP Baseline® Guide
✓ Establish a network to support you with on-the-job
challenges – including an introduction to ISPE’s
Containment Community of Practice (COP)
Increasing containment is necessary to minimise cross-
contamination, and as issues of cross-contamination are
"contained" operator protection must be addressed. Each
situation needs to be evaluated on a case-by-case basis, using
risk assessment tools such as ICH Q9 and ISPE’s Risk-MaPP
Baseline® Guide to identify the appropriate risk controls, as
well as set health-based limits to address both cross
contamination and operator protection.
To select appropriate containment technology, a partnership
of healthcare professionals must focus on identification of
hazards, exposure assessments, risk evaluation and
implementation of risk controls, as well as considering the
economic and regulatory impact of non-compliance.
A partnership of speakers from industry experts and subject
matter experts will use a series of case studies, workshops and
update sessions, to enable participants to develop successful
solutions to current containment issues. The seminar also
offers participants the opportunity to establish a network of
supporting resources for risk assessments for manufacturing
pharmaceutical compounds in their work setting.
Take Back To Your Job
• An introduction to ISPE's Risk-MaPP Baseline® Guide and
its application
• A clear understanding of hazard, risk and exposure and
how they affect each other
• Practical learning from case studies including engineering,
risk approach, process design, operational procedures and
operator training through presentations and workgroups
• Successful solutions to current containment issues
• A tool kit to help select risk controls that balance product
quality and operator protection – including an introduction
to the Containment COP
Agenda
Wednesday, 3 December
10.00 – 10.15 Welcome and IntroductionJohannes Rauschnabel, Robert Bosch GmbH
(Germany); Daniel De Grande, De Grande
Consulting (Belgium)
10.15 – 11.15 Containment Approach at Boehringer
IngelheimJürgen Fleckenstein, Boehringer Ingelheim
(Germany)
• OEB determination at Boehringer Ingelheim
• GMP and containment
• Risk management
11.15 – 12.15 Case Study 1: Contained Facility for Enzyme
ProductionBent Christensen, Novozymes (Denmark)
• Extreme OEL at high production volumes
12.15 – 13.45 Lunch and Networking Break
13.45 – 14.00 Introduction to Workgroup Tasks/Case
StudiesJohannes Rauschnabel, Robert Bosch GmbH,
(Germany); Daniel De Grande, De Grande
Consulting (Belgium); Richard Denk, Hecht
Anlagenbau (Germany)
• Three case studies to be elaborated in four groups
Containment Technology Forum -Applying ICH Q9 Principles to SelectingContainment Technology
3 – 4 December
Seminar Leaders:Johannes Rauschnabel, Robert Bosch GmbH(Germany); Daniel De Grande, De GrandeConsulting (Belgium)
▼
12.45 – 14.15 Lunch and Networking Break
14.15 – 14.30 Introduction to ISPE and COP ContainmentKate McCormick, ISPE (UK); Richard Denk, Hecht
Anlagenbau (Germany)
14.30 – 15.15 Case Study 3: High Level Containment OEB5Joost Nieuwlaat, JOA (Netherlands)
• Pros and cons of high level containment valves
• Impact to utilities, dedusting and process
infrastructure
• Design considerations dedusting system
• Example integrated project approach vendor/end
user
15.15 – 16.15 Questions and Answers, Close of SeminarJohannes Rauschnabel, Robert Bosch GmbH
(Germany); Daniel De Grande, De Grande
Consulting (Belgium)
11www.ISPE.org/barcelonaconference
14.00 – 15.45 WorkgroupsModerators: Johannes Rauschnabel, Robert Bosch
GmbH (Germany); Daniel De Grande, De Grande
Consulting (Belgium); Richard Denk, Hecht
Anlagenbau (Germany)
• Case study 1: Containment for OSD manufacture
• Case study 2: Containment for sterile cytotoxics
• Case study 3: API manufacture
15.45 – 16.15 Coffee and Networking Break
16.15 – 16.30 Workgroups (continued)Moderators: Johannes Rauschnabel, Robert Bosch
GmbH (Germany); Daniel De Grande, De Grande
Consulting (Belgium); Richard Denk, Hecht
Anlagenbau (Germany)
• Case study 1: Containment for OSD manufacture
• Case study 2: Containment for sterile cytotoxics
• Case study 3: API manufacture
16.30 – 17.45 Presentation of Results
17.45 – 18.00 Questions and Answers, Close of Day 1Johannes Rauschnabel, Robert Bosch GmbH
(Germany); Daniel De Grande, De Grande
Consulting (Belgium)
17.30 – 18.30 Networking Reception
Thursday, 4 December
09.00 – 09.15 Review of Day 1, Introduction to Day 2Johannes Rauschnabel, Robert Bosch GmbH
(Germany); Daniel De Grande, De Grande
Consulting (Belgium)
09.15 – 10.15 Aseptic Containments for Filling of LiquidProductsMathias Kreher, Robert Bosch GmbH (Germany)
• GMP vs. IH
• Containment isolator
• Containment RABS
• Case studies
10.15 – 10.45 Coffee and Networking Break
10.45 – 11.45 – Applying a Risk-based
Approach to the Manufacture of
Pharmaceutical Products Paul Wreglesworth, Astra Zeneca (UK)
• ISPE’s Risk-MaPP Baseline® Guide
• Hazard vs. risk
• Science-based decision making
• When to dedicate or segregate
11.45 – 12.45 Case Study 2: Safety and Efficiency through
Containment Manufacturing: NewCon
Project Illertissen/Germany Holger Weyhers, Pfizer (Germany)
• Session updates available online, visit
www.ISPE.org/barcelonaconference
Risk-MaPP
Agenda
Wednesday, 3 December
10.00 – 10.15 Welcome and IntroductionMark Cherry, Astra Zeneca (UK)
10.15 – 10.30 VPCS Overview Hilary Mills-Baker, CEL International (UK)
• VPCS background
• Principles used in the revision
• New VPCS document structure
10.30 – 11.15 OverviewSion Wynn, Conformity Ltd (UK)
• Key principals
• Science-based quality risk management
• Overview of the lifecycle approach
• Introduction to verification
• Leveraging supplier activities
11.15 – 13.00 VPCS Risk Management Mark Cherry, Astra Zeneca (UK); Karen Ashworth,
Karen Ashworth Consulting Ltd (UK)
• Principles of risk management for process control
• Risk management within the lifecycle
• Link to ICH Q8&9
• Principles of scalability across a range of examples
• Practical workshop
GAMP® 5
12www.ISPE.org/barcelonaconference
✓ Essential knowledge on the latest principles and
approaches in VPCS
✓ In-depth review of the revised ISPE GAMP® Guide for
Validation of Process Control Systems
✓ Understand the role of VPCS in implanting new
technologies and harmonising existing approaches
This seminar is intended to provide delegates with the latest
principles, concepts and approaches to the validation of
process control systems.
The seminar will provide details on how the planned revision
to the GAMP® Good Practice Guide for the Validation of
Process Control Systems will incorporate the principles in the
recently published GAMP® 5 Guide, and harmonise with other
related Good Practice Guides, including "A Risk-based
Approach to Compliant ERES", "Testing of GxP Systems" and
the updated C&Q Baseline® Guide.
Using a lifecycle approach to VPCS risk management issues,
speakers will identify core issues including project
management, governance procedures, operational approaches
and supplier assessment. Additionally, speakers will review
supporting processes, from change control to documentation
management.
As a result, the seminar offers a full programme of useful
information for delegates who regularly use ISPE’s VPCS Good
Practice Guide or who seek structure and guidance on
implementing efficient processes into their existing systems.
Take Back to Your Job
• New and updated information on the content of the
GAMP® Good Practice Guide for Validation of Process
Control Systems
• Insights on how this approach may be applied in practice
across a range of system types
• A better understanding of the importance of validated
process control systems in supporting the successful
implementation of new approaches like PAT
Validation of Process Control Systems(VPCS) – A Major Revision of the
3 – 4 December
Seminar Leaders:Mark Cherry, AstraZeneca (UK); Hilary Mills-Baker, CEL International Ltd (UK)
GAMP® Guide
▼
13www.ISPE.org/barcelonaconference
13.00 – 14.00 Lunch and Networking Break
14.00 – 15.00 Project Phase of LifecycleSue Tuxford, Emerson Process Management (UK);
David James, Invensys (UK); George Smerdon,
Industrial Technology Systems Ltd (UK); Hilary
Mills-Baker, CEL International (UK)
• Overview of validation planning
• Specification and review with workshop
15.00 – 15.15 Coffee and Networking Break
15.15 – 17.15 Project Phase of Lifecycle (continued)Sue Tuxford, Emerson Process Management (UK);
David James, Invensys (UK); George Smerdon,
Industrial Technology Systems Ltd (UK); Hilary
Mills-Baker, CEL International (UK)
• Coding and configuration with workshop
• Reporting and release
17.15 – 17.45 Questions and Answers, Close of Day 1 Hilary Mills-Baker, CEL International (UK)
17.30 – 18.30 Networking Reception
Thursday, 4 December
09.00 – 09.15 Introduction to Day 2Hilary Mills-Baker, CEL International (UK)
09.15 – 10.00 Update Speaker to be confirmed
• Alignment to E2500
• Linkage to Good Engineering Practice
• Harmonising with VPCS
C&Q Baseline® Guide
10.00 – 11.00 Project Phase of Lifecycle (continued)Gerhard Werling, Rockwell (Germany)
Reetu Chopra, Jacobs, (tbc)
• Verification activities
• Test stages
• Linkage to risk assessment
• Practical workshop
11.00 – 11.15 Coffee and Networking Break
11.15 – 11.45 GovernanceMark Cherry, Astra Zeneca (UK)
• Policies and procedures
• Roles and responsibilities
• System inventory
• Managing supplier relationships
11.45 – 12.45 Operations and RetirementBrian Nolan, Schering-Plough (Ireland)
• System security
• Incident management
• Business continuity
• Periodic review
• Legacy systems
• Data migration
12.45 – 14.00 Lunch and Networking Break
14.00 – 15.00 Supplier AssessmentMalcolm Knott, Industrial Technology Systems Ltd
(UK)
• Assessment techniques
• Scope and scalability of assessment activities
• Leveraging supplier documentation
• Workshop
15.00 – 15.45 Supporting Processes Hilary Mills-Baker, CEL International (UK);
Sue Tuxford, Emerson Process Management (UK);
Mark Cherry, Astra Zeneca (UK)
• Change control
• Configuration management
• Documentation management workshop
15.45 – 16.15 Questions and Answers, Close of SeminarMark Cherry, Astra Zeneca (UK)
14www.ISPE.org/barcelonaconference
✓ A complete update on scientific and technical issues
✓ Outline of new methodologies, processes and trends
✓ Understand the regulatory expectations for lyophilisation
and lyophilised products
Using a series of workshops and case studies, this
comprehensive two-day seminar covers the key issues
involved in applying a risk-based approach to lyophilisation.
Covering theory and practice, sessions will combine specific
aspects of risk assessment, identification of new technologies
and techniques (including sterilisation methodologies, the
development of PAT tools and new control methods) and
trends in monitoring.
Taking a pragmatic approach to the problems and pitfalls
of this complicated practice, speakers from a range of
backgrounds and approaches – industry, suppliers and
manufacturers – take a lifecycle approach to addressing some
of the challenges and risks. Regulatory expectations, including
the application of GMP Annex 1 are covered.
Speakers include industry experts, academics, practitioners,
suppliers and manufacturers to give a full and rounded view of
the latest technologies, tools and approaches.
Take Back to Your Job
• An understanding of regulatory requirements involved
in lyophilisation processes
• New trends and approaches in controlling lyophilisation
processes
• Knowledge of how and when to apply risk assessment
and risk control
Agenda
Wednesday, 3 December
10.00 – 10.15 Welcome and IntroductionMiquel Galan, Telstar (Spain); Pierre J. Le Meur,
SPEC Conseils (France)
10.15 – 11.00 Freezing: A Critical Step for Freeze-drying
Cycle Development and Product StabilityFernanda Fonseca, AgroParisTech/INRA (France)
• Identifying stresses encountered during freeze-
drying, and in particular during freezing. How to
limit them?
• Determining the critical events (nucleation) and
temperatures affecting product stability and cycle
efficiency
• Improving product stability and cycle efficiency
through formulation and/or process parameters
• Exploring two kinds of bioproducts: proteins and
bacteria
11.00 - 11.45 Regulatory Expectations for Lyophilisation
and Lyophilised ProductsJ. David Doleski, FDA (USA)
• Session updates available online, visit
www.ISPE.org/barcelonaconference
11.45 - 12.30 Understanding, Monitoring and Controlling
the Freeze-drying Process by Means of
Model-based Tools and Computational Fluid
DynamicsAntonello A. Barresi, Politecnico di Torino (Italy)
• Computational fluid dynamics and two-scale
models can strongly help in improving the product
uniformity of the batch
• The model-based control can guarantee the
quality of the product and reproducible process
conditions
• Detailed modelling of the apparatus can help to
improve the reliability of the monitoring sensors
(model-based monitoring) and thus of the control
system, taking into account variable gradients in
the chamber
12.30 – 14.00 Lunch and Networking Break
14.00 – 15.30 Workshop 1: Predicting the Operating
Parameters of a Lyo CycleMiquel Galan, Telstar (Spain)
• Rationale
• Choice of two ‘hands-on’ case studies – define
complete cycle parameters
• Participants will use the provided software tools
15.30 – 16.00 Coffee and Networking Break
Lyophilisation: Scientific Issues to theProcess and Introduction to Risk-basedApproach
3 – 4 December
Seminar Leaders:Miquel Galan, Telstar Lyo (Spain); Pierre J. Le Meur, SPEC Conseils (France)
▼
15www.ISPE.org/barcelonaconference
16.00 – 16.45 Parameter Characterisation of a
Lyophilisation CycleEnric Jo Cardoso, Reig Jofré Group (Spain)
• Thermal principles and the thermal fingerprint in
lyophilisation
• Lyophilisation recipe: Application of the thermal
outcomes
• Procedure to define the process set points: From
the formulation knowledge to the industrial plant,
and the security zone
• Different case studies: Shortening of cycles – how
to avoid the bottom from breaking; how to face
formulations with very low critical temperatures;
comparison of different cycles
16.45 – 17.15 Questions and Answers, Close of Day 1Miquel Galan, Telstar (Spain); Pierre J. Le Meur,
SPEC Conseils (France)
17.30 – 18.30 Networking Reception
Thursday, 4 December
09.00 – 09.15 Review of Day 1, Introduction to Day 2Miquel Galan, Telstar (Spain); Pierre J. Le Meur,
SPEC Conseils (France)
09.15 – 10.00 Vials Class A Capping in the Lyophilisation
ChamberAlain Fontaine, BIOCORP (France)
• Crimp sealing: Regulatory compliance
• Crimping options: Operational, quality, regulatory
and marketing perspectives
• Several packaging concepts provide means to
crimp-seal vials in the freeze dryer meeting the
regulation without a need for new equipment or
clean rooms
• Their design criteria, characteristics,
implementation in a pharmaceutical operation and
performance profile will be discussed and
compared
10.00 – 10.30 Coffee and Networking Break
10.30 – 11.15 GMP Manufacturing of Highly Potent
Freeze-dried Parenterals for Clinical Studies
Phases I and II. The Feedback of a
Pharmaceutical Contract ManufacturerMaxime Laugier, MP5 Laboratory (France)
• Manufacture of investigational medicinal
products: Follow the lead of GMP Annex 13
• A flexible and reliable manufacturing organisation
to meet a wide range of process and highly potent
products
• Manufacturing of highly potent freeze-dried
products: Presentation of some case studies
• Some advice prior to clinical manufacturing of
a highly potent parenteral freeze-dried product
11.15 – 12.00 Non Invasive Data Acquisition During the
Freeze-drying ProcessPierre Chouvenic, Sanofi Pasteur (France)
• Why the need for non invasive data acquisition
during the freeze-drying process?
• Critical parameters during the process
• What are the limitations of invasive data
acquisition?
• Non invasive data acquisition
• Non exhaustive list of techniques available for
R&D and industrial equipment
• Pros and cons from an industrial point of view
• Focus on manometric temperature
measurement
• Non invasive data acquisition to ensure freeze-
drying process robustness
12.00 – 13.30 Lunch and Networking Break
13.30 – 15.00 Workshop 2: Risk AssessmentPierre J. Le Meur, SPEC Conseils (France)
• Audience being divided in several groups, each
group will perform the risk assessment of part of
typical lyophilisation equipment and will present
the result to the other groups. Documentation
about the equipment will be presented and
assessed
15.00 – 15.45 Modern Freeze-drying Production Facility.
Description and Technical ChallengesErnesto Renzi, IMA EDWARDS (USA)
• Project definition
• Aseptic room classification
• Equipment layout and material flow
• Freeze-drying equipment main characteristics
• Loading - unloading configuration
• Project technical challenges
15.45 – 16.15 Questions and Answers, Close of SeminarMiquel Galan, Telstar (Spain); Pierre J. Le Meur,
SPEC Conseils (France)
16www.ISPE.org/barcelonaconference
Conference Social and Networking Evening
Monday 1 December
ISPE’s social networking events offer you the chance to join
fellow professionals including regulators, seminar leaders,
speakers, fellow delegates, colleagues and ISPE staff and
volunteers from Europe and the Unites States.
Join us in Barcelona to
• Meet like-minded professionals
• Catch-up with colleagues
• Reflect on the seminar you attended
• Discuss hot topics in pharmaceutical engineering
• Make new business contacts
• Follow up on questions and comments about Society
business
• Feed your mind – and your body!
Accompanying partners are welcome to join us at the Social
and Networking Evening.
For more details about this event, visit
www.ISPE.org/barcelonaconference
AgendaThe reception will start at 19.00
Networking Receptions
Monday, 1 December 17.30 – 18.30
Wednesday, 3 December 17.30 – 18.30
Enjoy an informal chat with colleagues at the
Hotel Rey Juan Carlos 1.
ISPE networking receptions provide the perfect
forum for debate and discussion, while also
offering you the chance to catch up with
colleagues and develop new contacts. This is
also an excellent chance to meet exhibitors at
the event and learn about the products,
services and new technologies that can help
your company excel.
Lunches and Coffee Breaks
Well-deserved breaks in your busy seminar
schedule, coffee and lunch breaks also offer
you the chance to discuss the days learning
with fellow delegates, visit with exhibitors and
network.
Barcelona Networking Events Barcelona Networking Events
17
VenueHotel Rey Juan Carlos I
Avda. Diagonal, 661-671
08028 Barcelona – Spain
Tel: +34 933 644 040
Fax: +34 933 644 264
www.hrjuancarlos.com
Accommodation
A block of rooms has been reserved at the venue for the ISPE
delegates at the preferential rate of €186 for a single or double
room (including breakfast and excluding 7% tax). This offer is
limited and we encourage you to register as early as possible.
All bedrooms are equipped with Wi-Fi Internet access, a port
for high-speed Internet access, fax (optional), direct dial
telephone, private safety deposit box, satellite colour TV,
individual temperature control, mini bar, luxury toilet
amenities, and a small kitchen.
Located on Barcelona´s main avenue, the Diagonal, the hotel
offers splendid panoramic views of the city and the sea and
offers easy access to the airport and the motorways to Madrid,
France and the Mediterranean coastline.
To book your accommodation at the Hotel Rey Juan Carlos I,
Barcelona, 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 checkout. Changes in
bookings or cancellations are only accepted in writing when
sent directly to ISPE Registration Services prior to the event
and no later than 14 November 2008. After this date, hotel
policies will apply (reservations cancelled between 14 days and
three days prior to the event will incur a charge of two nights
accommodation, after this time the hotel is entitled to charge
the entire value of the reservation). Other hotel options are
available at your own arrangements.
AccessFrom the airport Aeropuerto Barcelona El Prat
• Taxi – A taxi will take around 15 minutes, road conditions
dependent, and will cost around €25-€30.
• Train/Metro – The railway station is next to the airport.
Travel to station Sants Estació. Change to Metro line 3
(Green) and get out at the stop Zona Universitaria which is
a two-minutes walking distance from the hotel. The journey
will take around 40 minutes and cost around €2,50.
• Shuttle Bus/Metro - The Aerobus is a shuttle bus service that
links the Barcelona airport to the city centre. You can catch
the aerobus directly in front of the airport in all three
terminals. Get out at the first stop, Plaça Espanya. Take the
metro line 3 (Green) and get out at the stop Zona
Universitaria which is a two-minutes walking distance from
the hotel. Travel time is about 40 minutes, with an
approximate cost of €5.
ISPE Registration DeskThe ISPE Registration desk will be open at the following times:
Dates Times
• Sunday, 30 November 17.00 - 19.00
• Monday, 1 December 08.00 - 17.00
• Tuesday, 2 December 08.00 - 18.00
• Wednesday, 3 December 08.00 - 17.00
• Thursday, 4 December 08.00 - 10.00
Recommended DressThe recommended dress code is business casual.
Badges Name badges must be worn at all times. Delegates not wearing
their badges will be denied entrance to the conference.
Make the Most of Your StayIf you are able to take a few moments to enjoy Barcelona
before or after the conference, you may find it helpful to visit
www.barcelonatoursime.com to find out more about the
sights and sounds of the city.
www.ISPE.org/barcelonaconference
General Conference Information General Conference Information
18www.ISPE.org/barcelonaconference
Exhibition and Sponsorship Opportunities Exhibition and Sponsorship Opportunities
Table Top Exhibitions
European Table Top Exhibit packages include:
• Delegate access during three coffee breaks,
lunch, and a networking reception organised
in the exhibitor area of the conference
• Your company name featured on event pages
of ISPE Web site prior to the event
• 15% discount for two table top personnel
to attend the conference
Packages available for this conference include:
• 1-4 December (4 days)
• 1-2 December (2 days)
• 3-4 December (2 days)
Sponsorship Opportunities
ISPE offers your company unique opportunities to
build and reinforce your brand profile. Cost-effective
sponsorship opportunities enable you to further
engage with existing customers, target new audiences,
develop new business contacts and profile your
products and services to an audience of active industry
professionals.
Top Tier Sponsorships include:
• A literature display table near the conference
Registration/Welcome area
• Full-page advertisement in the final conference
programme (subject to deadlines)
• Company logo on event pages of ISPE Web site,
up to three months prior to the event
• Plus more
Additional sponsorship opportunities include:
• Vendor Sessions
• Networking Events
To learn more about sponsorship and table top opportunities and benefits, contact Christine Sainvil Tel : +32 2 740 2251 • Fax : + 32 2 743 1578 • Email: [email protected]
Host Sponsor:
Registration FeesConference Registration includes: • Conference Materials• Refreshment Breaks• Lunches• Networking Reception• Exhibition Access
If you register as a nonmember, you are entitled to acomplimentary one-year ISPE membership. To receive anapplication form, please tick the box on your conferenceregistration form. Your membership application must bereturned 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 telephone: +32 2 743 44 22 or fax: + 32 2 743 1584.
PaymentPayment must accompany the registration form. Registrationwill not be processed nor confirmed without payment in Euro (€). All registrations sent by fax must include the necessary payment information. American Express, Visa andMasterCard are accepted. Please complete the appropriatespaces and sign the registration form.
Early Registration DeadlineTo benefit from the early registration fee, payment must bereceived on or before 24 October 2008. After this date, thestandard registration fee will be applied.
ConfirmationUpon receipt of payment, a proof of payment will be sent toyou, along with your confirmation letter (time permitting).Hotel accommodation is not included in the registration fee.
Please present your registration confirmation letter at the ISPERegistration Desk at the Hotel Rey Juan Carlos I, Barcelona,Spain. You will receive your conference materials and personalname badge.
If you do not receive your confirmation letter, please contact:
ISPE Registration ServicesAvenue de Tervueren, 300B-1150 Brussels - BelgiumTel: +32 2 743 4422Fax: +32 2 743 1584Email: [email protected]
In order to be listed in the official delegate roster, you must beregistered and paid by 24 November 2008.
Cancellation PoliciesFull refunds, less a handling fee of €100 per registrant, will begranted to requests received in writing before or on 14 November 2008. No refunds will be granted for requestsreceived after 14 November 2008. Telephone cancellations arenot accepted.
LiabilityISPE reserves the right to cancel or reschedule any conferenceand/or to change speakers or instructors. Please be advisedthat ISPE is not responsible for any airfare/hotel penalties orother travel charges you incur.
In case of government intervention or regulation, militaryactivity, strikes or any other circumstances that make itimpossible or inadvisable for the ISPE Barcelona Conference togo ahead at the time and place provided, the participant shallwaive any claim for damages or compensation except theamount paid for registration after deduction of actual expensesincurred in connection with the conference. There shall be nofuture liability on the part of either party.
SubstitutionsIf a delegate is unable to attend, substitutions will be accepted;however nonmembers substituting for Members must pay thedifference in fees prior to the start of the event. ISPE cannot beheld responsible for lost airfare due to cancellation.
ISPE NoticeThe speakers invited to present ISPE’s programmes are leadingprofessionals in their respective fields. Should it be necessary,substitutions will be made. Every precaution is taken to ensureaccuracy, but ISPE cannot accept responsibility for the accuracyof information distributed or contained in these programmes,or for any other opinion expressed.
Group DiscountsSave 10%: Three to five participants from the same companylocation attending the conference at a single venue save 10%on registration fees.
Save 20%: Six to ten participants from the same companylocation attending the conference at a single venue save 20%on registration fees.
Discounts cannot be combined and Member and nonmemberpricing applies. Group registrations must be submitted at thesame time. Substitutions will be accepted. To benefit from agroup discount, you must fill in a group registration form. Theform is available at www.ISPE.org/barcelonaconference.
Emerging Economy Countries DiscountISPE offers a 50% discount off the normal early/lateregistration fees to Members from Emerging Economycountries. To review the list of eligible countries, visit: www.ISPE.org/EmergingEconomyList.
The discount will apply automatically when registration isprocessed.
www.ISPE.org/barcelonaconference19
Registration and Cancellation PoliciesRegistration and Cancellation Policies
www.ISPE.org/barcelonaconference
Please return to: ISPE Registration Services
Avenue de Tervueren, 300 • B-1150 Brussels, BelgiumEmail: [email protected] • Fax: + 32 2 743 1584
Registration FormRegistration Form
I. Delegate Information
ISPE Member: ❑ Yes, membership number______________________ ❑ No
Company VAT number (mandatory):____________________________________________________________________________
Prefix: ___________ First Name:_______________________________________ Last Name: ______________________________
Job Title: __________________________________________________________ Company: _______________________________
Address:____________________________________________________________________________________________________
City: _______________________________________________ Postal Code: ____________ Country: _______________________
Telephone:__________________________________________ Fax: ___________________________________________________
Mobile:_____________________________________________ Email:__________________________________________________
❑ I wish to keep my data confidential (only for use by ISPE and its local Affiliates and Chapters)
❑ I do not wish for my details to be printed in ISPE’s Membership Directory or on Conference Attendance Listings
II. Conference Registration Prices below do not include VAT – 16% Spanish VAT is applicable
GROUP DISCOUNT NOW AVAILABLEGROUP REGISTRATION FORM AVAILABLE ONLINE: www.ISPE.org/barcelonaconference
SAVE TIME – REGISTER ONLINE: www.ISPE.org/barcelonaconference
Payment received on Payment received Academia and or before after 24 October 2008 Emerging Government Student
24 October 2008 Economy MembersEarly Bird
Member Non Member Non Early Late One Onemember* member* Member Member Price Price
■■ Full Conference
Book two seminars - one per two-day series - and save 20% on the second seminar. €1.935 €2.275 €2.475 €2.815 €972 €1.242 €1.242 €270Please mark your seminars below:
1 – 2 December
❑ Successful Management of Sterile €1.075 €1.265 €1.375 €1.565 €540 €690 €690 €150❑ Products Quality ❑ Applied Risk Management €1.075 €1.265 €1.375 €1.565 €540 €690 €690 €150❑ Achieving Operational Excellence in €1.075 €1.265 €1.375 €1.565 €540 €690 €690 €150
Biomanufacturing: Trends and Case Studies
3 – 4 December
❑ Containment Technology Forum €1.075 €1.265 €1.375 €1.565 €540 €690 €690 €150❑ VPCS – Major GAMP Revision €1.075 €1.265 €1.375 €1.565 €540 €690 €690 €150❑ Lyophilisation: Scientific Issues of the Process €1.075 €1.265 €1.375 €1.565 €540 €690 €690 €150
and Introduction to Risk-based Approach
Networking Evening
❑ Monday 1 December €65 Accompanying partners are welcome to attend this event.
ISPE Members from Emerging Economy Countries benefit from a 50% discount on the regular registration fee.
Visit www.ISPE.org/EmergingEconomyList to review the full list of eligible countries.
❑ *Tick this box if you wish to become a member of ISPE for one year at no additional charge. An ISPE membership application form will be sent to you and must be returned to ISPE within 30 days in order to activate your membership.Offer available to nonmember conference delegates
❑ Tick here if you are a first time ISPE Conference attendee
III. Method of Payment – Conference 16% Spanish VAT should be included in the total payment
Seminar Fees € ––––––––––––––Networking Evening (Places ____ x €65) € ––––––––––––––Subtotal: € ––––––––––––––16% VAT: € ––––––––––––––Total Due: € ––––––––––––––
❑ Credit Card ❑ AMEX ❑ Visa ❑ Mastercard
Credit Card Number: _______________________________________________________ Expiry Date: _____________
Cardholder’s Name: ______________________________________________ Signature:
IV. Special Needs (dietary or other): _________________________________________________________________
V. Hotel ReservationPlease make the following reservation for me atHotel Rey Juan Carlos I, Avda. Diagonal, 661 – 671 – 08028 Barcelona, Spain
❑ Single Room (€186) ❑ Double Room (€186) Prices exclude 7% VAT. ❑ Smoking ❑ Non Smoking
(subject to availability)
Arrival Date : ___ /___/2008 Departure Date : ___ /12/2008
VI. SignatureBy signing I agree with the ISPE Registration and Cancellation Policies (see www.ISPE.org/barcelonaconference)
Date:_________________________________ Signature:
Please guarantee my reservation with the followingcredit card (mandatory):
❑ AMEX ❑ VISA ❑ MasterCard
Credit Card Number: ____________________________
Expiry Date:____________________________________
Cardholder’s Name _____________________________
Signature: