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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

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Bir

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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

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• Networking – Meet and greet peers from around the world through

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• 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

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® 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


11.45 – 12.30 Risk Assessment with Regard to Sterile

ProductsRob Walker on behalf of Tim Eaton, AstraZeneca

(UK)



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,


12.30 – 13.45 Lunch and Networking Break

13.45 – 14.30 FDA View on Risk ManagementSpeaker to be confirmed



14.30 – 15.15 MHRA View on Risk ManagementPaul Hargreaves, MHRA (UK)



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,


17.30 – 17.45 Questions and Answers, Close of Day 1Lynn Bryan, Ballygan Consulting (UK); Rob Walker,


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,


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)


10.35 – 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




✓ 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.


• 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


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


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


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


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)


Tuesday, 2 December

09.00 – 09.15 Review of Day 1, Introduction to Day 2Jörg Block, Bayer HealthCare AG (Germany)

Baseline® Guide

Risk-MaPP


• 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


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


which delegates will use to review manufacturing

risks


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


which delegates will use to address the critical

aspects of C&Q


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


✓ 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


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




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


• Summary of SUB implementation case studies

• Future technologies and strategies


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)



17.00 – 17.15 Questions and Answers, Close of Day 1Miriam Monge, Biopharm Services (France);



Tuesday, 2 December

08.30 – 08.45 Review of Day 1, Introduction to Day 2Miriam Monge, Biopharm Services (France);


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


10.35 – 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);



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);



✓ 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.


• 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


13.45 – 14.00 Introduction to Workgroup Tasks/Case

StudiesJohannes Rauschnabel, Robert Bosch GmbH,


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)

▼


14.15 – 14.30 Introduction to ISPE and COP ContainmentKate McCormick, ISPE (UK); Richard Denk, Hecht


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




14.00 – 15.45 WorkgroupsModerators: Johannes Rauschnabel, Robert Bosch

GmbH (Germany); Daniel De Grande, De Grande



• Case study 1: Containment for OSD manufacture

• Case study 2: Containment for sterile cytotoxics

• Case study 3: API manufacture


16.15 – 16.30 Workgroups (continued)Moderators: Johannes Rauschnabel, Robert Bosch

GmbH (Germany); Daniel De Grande, De Grande



• 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




Thursday, 4 December

09.00 – 09.15 Review of Day 1, Introduction to Day 2Johannes Rauschnabel, Robert Bosch GmbH



09.15 – 10.15 Aseptic Containments for Filling of LiquidProductsMathias Kreher, Robert Bosch GmbH (Germany)

• GMP vs. IH

• Containment isolator

• Containment RABS

• Case studies


10.45 – 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)



Risk-MaPP

Agenda


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


✓ 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.


• 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

▼



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


15.15 – 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)



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


11.15 – 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


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)


✓ 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.


• 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


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)



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


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


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)

▼


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,




09.00 – 09.15 Review of Day 1, Introduction to Day 2Miquel Galan, Telstar (Spain); Pierre J. Le Meur,


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


10.30 – 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


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,



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


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.


General Conference Information General Conference Information


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)



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


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:

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