www.ISPE.org/2010BrusselsConference
20–23 September 2010 • Sheraton Hotel • Brussels, Belgium
ISPE
Sponsorship and Table Top Exhibit Opportunities Available
Brussels
Conference
Risk-based Control Strategies
in Pharmaceutical Industries
20-21
September 2010
■
Barrier Isolation Technology Forum:
Innovation, Updates, New Case Studies
■
Dedicated Facilities, Cross
Contamination and the Risk-MaPP
Approach
■
GAMP ® : A Guided Tour of the World
of Good Practice Guides
■
PQLI®: Case Studies in QbD for
Biotechnology and Small Molecule
Product Realisation
22-23
September 2010
■
Containment: The Devil is in the Detail
■
Investigational Products (IP):
Lean and Compliant? Applying Efficient
Tools to a Regulated Clinical Supply Chain
■
Science and Risk-based Commissioning
and Qualification (C&Q):
Transitioning and Transforming
Training
Courses
■
Sterile Drug Manufacturing Facilities:
Applying ISPE Baseline ® Guide and
FDA Guidance Principles to Design
and Operation
■
Practical Application of Computerised
Systems Compliance GAMP ® 5
(includes online course)
r
NEW Semina
on Risk-MaPP
Conference
Highlights:
■
Workshops
■
Case Studies
■
Networking Reception
■
Training
■
Table Top Exhibition
ISPE 2010 Brussels Conference At-A-Glance
ISPE 2010 Brussels Conference and Training Schedule
20-23 September 2010
Sheraton Hotel • Brussels, Belgium
Date
Monday
20 September
Tuesday
21 September
Conference Seminars
Barrier Isolation
Technology Forum:
Innovation,
Updates,
New Case Studies
Wednesday
22 September
Thursday
23 September
Containment:
The Devil is
in the Detail
Dedicated Facilities,
Cross
Contamination
and the Risk-MaPP
Approach
Network
Events
Training Courses
Exhibition
Networking
PQLI®:
Case Studies in
QbD for
Biotechnology
and Small Molecule
Product Realisation
GAMP®:
Guided Tour of
the World
of Good
Practice Guides
Sterile Drug
Manufacturing
Facilities: Applying
ISPE Baseline® Guide
and FDA Guidance
Principles to Design
and Operation
Investigational
Science and
Products (IP):
Risk-based
Lean and Compliant? Commissioning and
Applying Efficient Qualification (C&Q):
Tools to a Regulated
Transitioning and
Clinical Supply Chain
Transforming
Practical
Application of
Computerised
Systems
Compliance
GAMP® 5
Exhibition
Networking
Exhibition Networking Receptions
Monday 20 September
17.45 – 18.45
The mouse symbol indicates that the course includes a
Wednesday 22 September 17.45 – 18.45
Webinar, a pre-recorded, online session that provides
Exhibition networking receptions offer you a chance to engage
a review of the basics prior to the conference.
with fellow seminar delegates and exhibitors. Catch up with
colleagues, meet like-minded professionals, make new business
contacts, and relax after the first day’s seminar sessions.
ISPE Communities of Practice (COPs)
Many ISPE courses and seminars are developed by ISPE COPs.
These interactive online communities provide access to specific
bodies of knowledge, and allow professionals around the world
to engage in electronic discussions on topics of interest; to
collaborate on documents, important resources, and content
relevant to the discipline; and to solve everyday problems with
pragmatic approaches. Learn more about the current COPs and
join groups of interest at www.ISPE.org/COPs. Current COPs
with abbreviations:
• Critical Utilities (CU)
• Disposables
• Engineering Standards Benchmarking (ESB)
• Good Automated Manufacturing Practice (GAMP)
• Good Control Laboratory Practices (GCLP)
• Heating, Ventilation, and Air Conditioning (HVAC)
• Investigational Products (IP)
• Operations Management
• Oral Solid Dosage (OSD)
• Packaging
• Process Analytical Technology (PAT)
• Active Pharmaceutical Ingredients (API)
• Process/Product Development (PPD)
• Biotechnology (Biotech)
• Project Management (PM)
• Commissioning and Qualification (C&Q)
• Sterile Products Processing (SPP)
• Containment
• Sustainable Facilities
ISPE Membership has its Benefits
Whether you are new to the industry or a seasoned professional, a long-time Member or new to the Society, ISPE has something for you.
Knowledge - Increase your understanding, keep yourself current, and make yourself marketable
Community - Meet like-minded professionals, share ideas about real world problems, and build a network upon which you can rely
Profession - Advance your career, become part of changing the industry, and help others grow professionally
Now, more than ever, we look forward to showing you why ISPE deserves to be your Society of Choice!
www.ISPE.org/Membership
2
ISPE 2010 Brussels Conference on Risk-based Control Strategies in Pharmaceutical Industries
www.ISPE.org/2010BrusselsConference
Certified Pharmaceutical Industry Professional™
Knowledge Elements Reference Chart
Brussels conference seminars and training courses contain knowledge related to the seven technical knowledge
competency areas for the Certified Pharmaceutical Industry Professional (CPIP™) certification programme, an
international credential made available through the ISPE Professional Certification Commission. Although completion of
any of these seminars does not guarantee successful completion of the CPIP™ certification programme certification
exam, they would be an excellent part of your preparation. Visit www.ISPE-PCC.org to find out more about CPIP™.
1
2
CPIP™
Certification Programme
Technical Knowledge
Competency Areas
Product Development
Facilities and Equipment
A
Formulation, clinical phases, and manufacture
B
Technology transfer
C
A
Production scale-up and optimisation
B
Commissioning and qualification as a risk management strategy
C
D
Operation and maintenance
Design and construction/installation
Controls and automation
3
Information Systems
A
Information Systems
4
Supply Chain Management
A
Materials management
B
Operational economics
C
Warehouse and distribution management
A
B
Production unit operations – drug (small molecule) and biologics
C
Production control
5
Production Systems
Production management
6
Regulatory Compliance
(Drugs, Env, Health, Safety)
A
B
Government regulations
7
Quality Systems
A
Risk management and Quality Management System (QMS)
B
Systems validation
Standards, practices, and guides
Technical Knowledge Competency Areas
1
2
3
4
5
6
7
2010 Brussels Conference
Seminars
A B C A B C D A A B C A B C A B A B
Barrier Isolation Technology Forum: Innovation, Updates,
New Case Studies
Dedicated Facilities, Cross Contamination and the RiskMaPP Approach
GAMP®: A Guided Tour of the World of Good Practice
Guides
®
PQLI : Case Studies in QbD for Biotechnology
and Small Molecule Product Realisation
Containment: The Devil is in the Detail
Investigational Products (IP): Lean and Compliant?
Applying Efficient Tools to a Regulated Clinical Supply Chain
Science and Risk-based Commissioning and Qualification
(C&Q): Transitioning and Transforming
Sterile Drug Manufacturing Facilities: Applying ISPE Baseline®
Guide and FDA Guidance Principles to Design and Operation
Practical Application of Computerised Systems Compliance
GAMP® 5
CPIP™ Certification Programme “How-to” Workshops
These workshops will take place on Monday 20 September 12.30 – 13.15 and Thursday 23 September 13.00 – 13.30
Interested in becoming a Certified Pharmaceutical Industry Professional™? Anders Brummerstedt, CPIP, and member of the ISPE
Professional Certification Commission, will lead these complimentary workshops, and provide guidance on how to submit a CPIP
certification programme eligibility application and prepare for the CPIP certification programme examination. Topics include: obtaining a
University transcript, completing the professional experience forms, utilising the CPIP certification programme Study Guide resources,
and organising CPIP certification programme study groups. Visit www.ISPE-PCC.org for more information.
ISPE 2010 Brussels Conference on Risk-based Control Strategies in Pharmaceutical Industries
www.ISPE.org/2010BrusselsConference
3
Barrier Isolation Technology Forum:
Innovation, Updates, New Case Studies
Seminar Leaders:
Charlotte Enghave Fruergaard, NNE Pharmaplan
(Denmark);
Jack Lysfjord, Lysfjord Consulting, LLC (USA)
This seminar presents developing technology and
regulatory perspectives for barrier isolation,
20-21 September
Take Back to Your Job:
• Describe updated technologies applicable to advanced aseptic processing
using BFS, RABS, and barrier isolation
• Describe how robotics can improve clinical manufacturing
• Understand protein sensitivity to hydrogen peroxide
• Interpret regulatory agency perspectives to streamline your regulatory
submission and approval process
especially in regard to advanced aseptic
• Participate in peer discussion groups on advanced aseptic processing issues
processing, restricted access barrier systems
• Understand what to do and what not to do from those who have done it
(RABS), and isolators.
It will feature a variety of topics including
robotics, E-beam sterilisation of syringe tubs,
measurement of hydrogen peroxide, biological
before
• Apply best practices from case studies
Who Should Attend:
sensitivity to hydrogen peroxide, clinical trial
materials produced in an isolator, a biotech facility
• Engineering, operations, validation, regulatory, and project management
using isolators, and several contract
personnel from companies in operations as well as equipment vendors that
manufacturing examples using these techniques.
supply the industry with process equipment.
Content includes multiple case studies and
interactive workshops on topics of global
importance. Hear speakers from Europe and
North America, and participate in a regulatory
question and answer session.
Communities of Practice
(COPs):
Related Technical Documents:
• ISPE Baseline® Guide: Volume 3 - Sterile Manufacturing Facilities
Technical Knowledge and Competency
Elements:
A chart of the CPIPTM certification programme categories addressed by this
seminar is shown on page 3.
Biotech, Commissioning and Qualification,
Containment, Disposables, Engineering Standards
Benchmarking, HVAC, Investigational Products,
Product Process Development, Sterile Products
Processing, Sustainable Facilities
4
Seminar Content Level:
Fundamental
●
Intermediate
ISPE 2010 Brussels Conference on Risk-based Control Strategies in Pharmaceutical Industries
www.ISPE.org/2010BrusselsConference
●
Advanced
17.10 – 17.40
Day 1
10.00 – 10.10
Carmine Stropoli, Parsons (USA)
• Phasing-in isolation technology
• Intervention and components transfer
• Operational flow and area classification
• Facility, process and mechanical spatial requirements
• Determing whether the approach is viable for
specific filling projects
Welcome and Introduction
Charlotte Enghave Fruergaard, NNE Pharmaplan
(Denmark); Jack Lysfjord, Lysfjord Consulting LLC
(USA)
10.10 – 10.50
10.50 – 11.35
Isolator History and Trends 2010 Preliminary
Data
Jack Lysfjord, Lysfjord Consulting LLC (US)
• Global numbers for fill finish isolators
• Regional differences: Asia, Europe and North
America
• Compare both to prior data and look at trends
with isolator usage
17.40 – 17.45
Clinical Aseptic Processing Fill Finish Line
for Liquid or Freeze-dry Products
Day 2
Dieter Bandtel and Mathias Kreher, Bosch (Germany)
• Flexibility for various filling systems
• Minimised product loss
• Modular barrier concept
• Easy to use barriers
11.35 – 12.15
Pharmaceutical Industry Trends and Their
Influence on Isolator Technology
Thomas Huber, Skan (Switzerland)
• Fast H2O2 decontamination
• Safe filter change
• H2O2 low ppm impact on product
• E-Beam technology
• Further future developments
12.15 – 13.45
Lunch and Networking Break
13.45 – 14.25
In-situ Characterisation of Vapor Phase H2O2
Case Study – Effects of Residual Vapor Phase
Hydrogen Peroxide and In-line Measurement
of Residual VPHP
17.45 – 18.45
09.00 – 09.10
Break
15.40 – 16.25
VPHP Absorption/Desorption and Its Impact
with the Use in Barrier Systems
09.10 – 10.15
Breakout Discussion Groups
10.15 – 10.45
Break
10.45 – 11.15
Discussion Group Summaries
11.15 – 12.00
Case Study – A New Biotech Production
Facility for Aseptic Processing of Vials with
Dual Fill Finish Lines
Barry Starkman, Genentech (US)
• Facility overview, product and people flow, cost
and schedule
• Isolator decision vs. cleanroom, RABS rationale
and cost analysis
• Overview of the isolator filling processes,
equipment selection and difference between
liquid and lyo
• The validation process and the use of “design of
experiments”
• Surprises and learnings
12.00 – 12.45
Contract Production, Multi Product Fill Finish
Facility for Vials and Syringes
Ryan Hawkins, Cook Pharmica (US)
• Facility and line overviews including isolator decision
• Process design and coordination effort
• Product path options including disposables
• Material and component transfer considerations
• Qualification and validation overview
• Lessons learned
12.45 – 14.15
Lunch and Networking Break
14.15 – 15.00
Campaign Filling of Biotech Products in
Isolator Setup
Wolfgang Epple, Johnson & Johnson (Switzerland)
• SCF process cycle time reduction for biotech
products resulting in production efficiency and
capacity increase
• Reduction of changeover time during campaign
filling in isolator setup
• Reduction of the average product loss rate by
means of process optimisation resulting in
significant API cost savings
Placebo To Potent - Experiences of a Clinical
Barrier Isolator Facility
Brant Bulgarelli, BMS (US)
• Learn how clinical trial demands differ from full
scale production
• Debunk the myth that isolators are too rigid for
clinical supply manufacturing needs
• Case studies of clinical product manufacture
including highly potent and solvent-containing
formulations
• Review lessons learned across design, fabrication,
validation, and 24 months of GMP operations
Review of Day 1, Introduction of Day 2
Visit www.ISPE.org/2010BrusselsConference for
updated session information.
Mike Walsh, Lilly (US)
• VPHP measurement technologies
• Absorption/desorption of H2O2 in different materials
• Aeration studies
16.25 – 17.10
Exhibition Networking Reception
Charlotte Enghave Fruergaard, NNE Pharmaplan
(Denmark); Jack Lysfjord, Lysfjord Consulting LLC
(USA)
Sokhorn Yim, Genentech (US)
• New technology to measure low level residual
vapor phase hydrogen peroxides (VPHP)
• Protein sensitivity to H2O2
• VPHP cycle development at the new Genentech
filling facility
• In depth knowledge of the aeration cycle
15.10 – 15.40
Summation and Close of Day 1
Charlotte Enghave Fruergaard, NNE Pharmaplan
(Denmark); Jack Lysfjord, Lysfjord Consulting LLC
(USA)
Ron Chiorello, Jetalon Solutions (US)
• Key physical properties of VHP processes for
monitor and control
• Current methods for monitoring VHP processes
• Novel method for simultaneous and real-time
monitoring of VHP processes
• Comparison of the current methods and
recommendation for a best known method (BKM)
for monitor and control of VHP processes
14.25 – 15.10
A Phased Approach to Applying Barrier
Isolation Technology to Cartridge Filling
15.00 – 15.45
Regulatory Comments, Questions and Answers
Ian Thrussell, MHRA (UK)
Visit www.ISPE.org/2010BrusselsConference for
updated session information.
15.45 – 16.00
Questions and Answers, Close of Seminar
Charlotte Enghave Fruergaard, NNE Pharmaplan
(Denmark); Jack Lysfjord, Lysfjord Consulting LLC
(USA)
ISPE 2010 Brussels Conference on Risk-based Control Strategies in Pharmaceutical Industries
www.ISPE.org/2010BrusselsConference
5
Dedicated Facilities, Cross Contamination and
the Risk-MaPP Approach
20-21 September
Seminar Leaders:
Take Back to Your Job:
Stephanie A. Wilkins, PharmaConsult US, Inc
• Determine when multi-product facilities can be used
(USA);
• Use the logic diagramme to guide a team through the process of determining
Nigel Hamilton, Sanofi Aventis (UK)
As manufacturers are looking to reduce cost and
increase efficiency, more multi-product facilities
are being utilised either directly by the
manufacturers or through partnerships with
contract manufacturing organisations (CMOs).
With the use of multi-product facilities, the risk of
cross contamination increases. By properly
how to manage the risk of cross contamination
• Understand where to get health-based data for use in risk assessments
• Develop scientific risk-based cleaning validation limits
• Understand how others have implemented Risk-MaPP principles into their
operations
• Prepare a quality risk management plan for cross contamination
Who Should Attend:
managing the risk of cross contamination
manufacturers can reap the benefit of lower cost
• Anyone dealing with multi-product facilities especially QA, toxicologists,
and higher efficiency while maintaining product
EH&S professionals, engineers, operations, cleaning validation, project
quality and patient safety.
managers, regulators/ inspectors
The much anticipated release of ISPE’s new RiskMaPP Baseline® Guide provides a scientific
risk-based methodology based on ICH Q9 to
manage the risk of cross contamination.
A series of workshops and case studies led by the
Related Technical Documents:
• Risk-based Manufacture of Pharmaceutical Products (Risk-MaPP); A Guide
to Managing the Risks Associated with Cross-Contamination
• Knowledge Brief: Risk-based Approaches to Cross Contamination
Guide authors will focus on use of the logic
diagramme, how health based limits are developed,
setting cleaning validation limits, risk assessments for
cross contamination and formulating a Quality Risk
Management Plan as part of a Quality System.
Basic and background information will be provided
Technical Knowledge and Competency
Elements:
A chart of the CPIP™ certification programme categories addressed by this
seminar is shown on page 3.
via webinar prior to the conference so that more
time can be spent on workshops and case studies.
Seminar Content Level:
Upon registration, a copy of the guide will be
sent to you (after anticipated publication during
Fundamental
●
Intermediate
third quarter 2010) so that you can get familiar
with the document prior to the workshops; please
bring your copy to the seminar. Note that if you
cancel your attendance, you will be charged for
the document plus shipping.
Community of Practice
(COP):
API, Biotech, C&Q, Containment, HVAC,
Investigational Products, OSD, Product Process
Development, Project Management, Sterile
Products Processing
6
ISPE 2010 Brussels Conference on Risk-based Control Strategies in Pharmaceutical Industries
www.ISPE.org/2010BrusselsConference
●
Advanced
Day 2
Day 1
10.00 – 10.20
Welcome, Introduction and Set Up
Workshops
Stephanie Wilkins, PharmaConsult Us, Inc (USA)
Nigel Hamilton, Sanofi-Aventis (UK)
10.20 – 11.40
12:50– 13.35
13.35 – 14.35
Break
15.50 – 16.35
Using Risk-MAPP Through the Product
Lifecycle
Nigel Hamilton, Sanofi-aventis (UK)
• Risk management for product and process
development
• Risk management for tech transfer
• Risk management for qualification, validation and
continuous verification
• Risk management for continuous improvement
and end of lifecycle
10.30 – 11.15
How to Incorporate Risk-MaPP into Quality
Systems
Jeff Campie (USA)
• How Risk-MaPP fits into the quality system?
• Workshop on incorporating Risk-MaPP principles
into the quality system (developing/ enhancing
governance documents)
11.15 – 12.45
Pulling it All Together
Stephanie Wilkins, PharmaConsult Us, Inc (USA)
• Structuring the QRMP document
• Preparation of a Quality Risk Management Plan
summarizing the tasks from all the workshops
• Presentation of “QRMPs” to the group
12.45 – 13.30
Lunch
13.30 – 14.30
élan Case Study
Mark O’Reilly, Aisling Horan élan (Ireland)
Integration of Risk-MaPP principles into elan’s
• Integration of Risk-MaPP principles into elan’s
operations
• The impact of Risk-MaPP on operations
• The regulator reaction to the QRMP based on
Risk-MaPP principles
14.30 – 15.15
How FDA will Incorporate Risk-MaPP into
Inspections
Edwin Melendez (Invited) FDA (USA)
• Using Risk-MaPP to help identify high risk
manufacturing
• Fitting Risk-MaPP into cleaning validation
• Risk assessment/ management model addressing
controls to comply with 21CFR 211.42c
15.15 – 16.00
EMA Status on Dedicated Facilities and
Risk-MaPP
Catherine Lefebvre (Invited) Afssaps (France)
• Update on status of EMA dedicated facilities
revisions
• Lessons from the field
• The best way to apply Risk-MaPP from a
regulatory point of view
OsoBio Case Study
Kim Ray, Oso Biopharmaceuticals (USA)
• Incorporation of Risk-MaPP principles into Oso’s
operation
• Effect of Risk-MaPP on Oso’s interactions with
clients
• Reaction of global regulatory bodies to the QRMP
17.30 – 17.45
Break
Logic Diagram and Balancing IH/GMP Needs
15.35 – 15.50
16.35. – 17.30
10.15 – 10.30
Risk Analysis/ Control
Paul Wreglesworth, Independent Consultant,
formerly AstraZeneca (UK)
• Introduction to the logic diagram and how
to use it
• Workshop on the logic diagram and balancing IH
and GMP needs
How Formulations Can Affect Risk
Tom Brennan, Eirgen (Ireland)
• How formulation can affect the risk of cross
contamination or operator exposure
• Workshop to assess risk with different
formulations and see the impact
Lunch and Networking Break
Julian Wilkins, PharmaConsult Us, Inc (USA)
• Review of risk analysis and risk management tools
• Workshop on use of risk management tools to
analyse risk of cross contamination
• Review of methods to reduce/ control risk
• Workshop on risk control
14.35 – 15.35
09.15 – 10.15
Cleaning
Andrew Walshn Clean6Sigma, Stevens Institute of
Technology (USA)
• Workshop on design of experiments to assist with
cleaning validation
• Workshop on setting STVs for cleaning
• Workshop on the apparent safety margin and
how to set cleaning validation limits
Review of Day 1, Introduction of Day 2
Stephanie Wilkins, PharmaConsult Us, Inc (USA)
Setting Limits
Bruce Naumann, Merck (USA)
• Risk identification with workshop on reviewing
MSDS (Material Safety Data Sheets), package
inserts and internet resources
• Derivation of Acceptable Daily Exposures (ADEs)
• Addressing compounds with difficult endpoints
• Workshop on setting ADEs
11.40 – 12:50
09.00 – 09.15
16.00 – 16.15
Questions and Answers, Close of Seminar
Stephanie Wilkins, PharmaConsult Us, Inc (USA)
Questions and Answers, Close of Day 1
Stephanie Wilkins, PharmaConsult Us, Inc (USA)
Nigel Hamilton, Sanofi-aventis (UK)
17.45 – 18.45
Exhibition Networking Reception
ISPE 2010 Brussels Conference on Risk-based Control Strategies in Pharmaceutical Industries
www.ISPE.org/2010BrusselsConference
7
GAMP ®: Guided Tour of the World of Good Practice Guides
20 - 21 September
Seminar Leaders:
Take Back to Your Job:
Jens Seest, Leo Pharma (Denmark);
• Identify which GPGs are relevant for your job
Tim Goossens, MSD (Belgium)
• Understand how each GPG provides benefit in your job
The seminar will focus on GAMP Good Practice.
It will provide the delegates with an overview of
the guides, together with case studies and
• Be aware of applications of best practice via case studies
• Understand the regulatory viewpoint on the GPGs
workshops.
Who Should Attend:
The objective is to help the delegates to identify
• Practitioners operating computerised systems e.g. automated systems,
which particular good practice guide is relevant
for their job. The presentations will not be in-
laboratory computerised systems, information systems and IT infrastructure
• Site engineers, system supporters, IT department
depth technical by nature, but more from an
application perspective.
Community of Practice
(COP):
Related Technical Documents:
GAMP® Good Practice Guides:
• Manufactering Execution Systems – A Strategic and Program Management
Approach
• Electronic Data Archiving
GAMP
• IT Infrastructure Control and Compliance
• Global Information Systems Control and Compliance
Technical Knowledge and Competency
Elements:
A chart of the CPIPTM certification programme categories addressed by this
seminar is shown on page 3.
Seminar Content Level:
Fundamental
8
●
Intermediate
ISPE 2010 Brussels Conference on Risk-based Control Strategies in Pharmaceutical Industries
www.ISPE.org/2010BrusselsConference
●
Advanced
Day 2
Day 1
10.00 – 10.15
Welcome and Introduction
09.00 – 09.15
Jens Seest, Leo Pharma (Denmark);
Tim Goossens, MSD (Belgium)
10.15 – 11.30
Jens Seest, Leo Pharma (Denmark);
Tim Goossens, MSD (Belgium)
Introduction to and Overview of the Good
Practice Guides
09.15 – 10.15
MES - Case Study
Paul Irving, Aptitude (UK);
Anders Brummerstedt, NNE Pharmaplan (Denmark)
• Overview of the MES Guidance: strategic
planning, a domain of functionality, describe
electronic production records, review by exception
• MES implementation: complexity and
organisation, business process analysis, master
data, systems interfaces, key people and key
knowledge, governance issues
Chris Reid, Integrity Solutions (UK)
• Introduction to main documents referenced in this
seminar: MES; Data Archiving; Infrastructure;
Global Information Systems
• Overview of other available guidance documents
11.30 – 12.15
Review of Day 1, Introduction to Day 2
Regulatory Overview
Speaker to be confirmed
Visit www.ISPE.org/2010BrusselsConference for
updated session information.
10.15 – 10.45
Break
12.15 – 13.45
Lunch and Networking Break
10.45 – 12.30
Data Archiving - Case Study and Workshop
13.45 – 15.15
Infrastructure Compliance Lifecycle
Presentation and Workshop
Kofi Frimpong, Merial (USA)
Tom Meulders, Dataflow Consultancy (Belgium)
The consequences of IT Infrastructure being of
effective compliance can be significant since it has a
direct impact on the validation status of the GxP
applications hosted on them. This session discusses
a scalable, cost-effective IT infrastructure
compliance and control process which focuses on:
• The paradigm shift from manual infrastructure
qualification to using scalable prequalified
infrastructure components (building blocks)
• Using scripted verification reports to provide
verifiable assurance of compliance with
predefined standards
• Ongoing maintenance of the qualified state,
including incident, change and configuration
management
• Piloting a new IT infrastructure qualification
methodology in an international organisation,
project challenges and lessons learned
• Scalable prequalified infrastructure components
(building blocks)
• Using scripted verification reports to provide
verifiable assurance of compliance with
predefined standards
• Ongoing maintenance of the qualified state,
including incident, change and configuration
management
• Piloting a new IT infrastructure qualification
methodology in an international organisation,
project challenges and lessons learned
15.15 – 15.45
Break
15.45 – 17.30
Infrastructure Compliance Lifecycle
Case Study and Workshop (continued)
Peter Werner Christensen and Niels Andersen, NNE
Pharmaplan (Denmark)
Issues around the long term preservation of
electronic data.
• Regulatory view on electronic records
• Archiving concepts - electronic versus paper
archiving
• Considerations when archiving electronically
• Developing an archiving strategy
12.30 – 13.30
Lunch and Networking Break
13.30 – 16.00
Global Information Systems – Case Study
and Workshop
Winnie Cappucci, Bayer (USA);
Randy Perez, Novartis (USA)
Validation and compliance can be tricky issues to
manage for computer systems that are deployed at
multiple sites, whether internationally or intranationally. This session addresses a variety of issues
unique to managing the development and support
of validated global computer systems such as:
• The affect of system architecture on validation
strategy
• Minimising duplicated effort: leveraging
centralised testing
• Data management for global systems
• Global system management, including managing
change, configuration, and security
16.00 – 16.15
Questions and Answers, Close of Seminar
Jens Seest, Leo Pharma (Denmark);
Tim Goossens, MSD (Belgium)
Kofi Frimpong, Merial (USA);
Jo De Troy, Johnson & Johnson (Belgium);
Tom Meulders, Dataflow Consultancy (Belgium)
• Differences between manual infrastructure
qualification and scripted infrastructure
qualification
• Advantages and disadvantages of the new process
• Future deployment strategies
• Workshop – hands-on exercise
17.30 – 17.45
Questions and Answers, Close of Day 1
Jens Seest, Leo Pharma (Denmark);
Tim Goossens, MSD (Belgium)
17.45 – 18.45
Exhibition Networking Reception
18.45 – 20.30
Infrastructure: Round Table Discussion in
Cooperation with GAMP Benelux Cop
Tim Goossens, MSD (Belgium)
ISPE 2010 Brussels Conference on Risk-based Control Strategies in Pharmaceutical Industries
www.ISPE.org/2010BrusselsConference
9
PQLI®: Case Studies in QbD for Biotechnology and
Small Molecule Product Realisation
20-21 September
Seminar Leaders:
Take Back to Your Job:
Ranjit R. Deshmukh, MedImmune (USA)
• Understand the application of both simple and advanced Quality by Design
Is Quality by Design (QbD) applicable to
biotechnology? Yes, and by participating in this
two-day Product Quality Lifecycle
Implementation® (PQLI®) workshop you will
understand and discuss the A-Mab case study,
which is the latest thinking in the application of
QbD to biotechnology.
This workshop provides the ideal forum to
understand and take away practical examples of
how principles of QbD can be applied to
principles and their application, for example in manufacturing
• Apply tools and processes to identify critical quality attributes and process
parameters
• Explain how integrated control strategies can be developed
• Discuss regulatory implications of application of QbD
• Input to PQLI’s programme to implement a modern pharmaceutical quality
system
Who Should Attend:
• Development, manufacturing, operations, technical services, quality
biotechnology, product development, and
assurance, quality control, process engineers, regulatory affairs, senior
manufacturing. To complement the biotech
management, and life sciences professionals
approach and for comparison, a second case
study developed by a PQLI team (a core
component of a forthcoming ISPE Good Practice
Guide on Product Realisation) will be presented
that explains QbD principles for a small molecule
drug substance and drug product.
Through these case studies and discussion you
will better understand tools and processes to
identify critical quality attributes and process
parameters, as well as how an integrated control
strategy can be developed and implemented in
manufacturing. Additionally, the regulatory
implications of what has been proposed can be
Related Technical Documents:
• A-Mab Case Study accessible on the PQLI® Web site, www.ISPE.org/PQLI
Technical Knowledge and Competency
Elements:
A chart of the CPIPTM certification programme categories addressed by this
seminar is shown on page 3.
Seminar Content Level:
discussed. PQLI’s early thoughts will be discussed
on implementation of a modern pharmaceutical
quality system, for example a company change
Fundamental
●
Intermediate
management process.
Communities of Practice
(COPs):
Sponsoring COPs: Biotech, PAT, Product Process
Development
Related COPs: API, OSD, Sterile Products
Processing
10
ISPE 2010 Brussels Conference on Risk-based Control Strategies in Pharmaceutical Industries
www.ISPE.org/2010BrusselsConference
●
Advanced
Day 1
10.00 – 10.10
Day 2
Welcome and Introduction
09.00 – 09.15
Ranjit R. Deshmukh, MedImmune (USA)
10.10 – 10.50
EU Regulatory Feedback on QbD
Applications in Biotechnology
Ranjit R. Deshmukh, MedImmune (USA)
09.15 – 10.30
Matts Welin, Medical Product Agency (Sweden)
(invited)
• Regulatory perspective on number of QbD related
submissions in biotechnology products
• Key emergent issues in these submissions
• What are the implementation areas EMA
regulators would like to see developed more
10.50 – 11.30
11.30 – 12.10
Tom Garcia, Pfizer (USA)
• Examples on use of models
• How do you maintain models?
• Implementation challenges for small molecules
and biologics
10.30 – 11.00
Break
Patrick Swann, USFDA (USA)
• Current status of the pilot programme
• Consensus element sponsors are implementing
well
• Opportunities for more dialogue and more
industry data
11.00 – 12.30
Workshop 4 - How Much QbD for Raw
Materials and Excepients: Small Molecules
and Biologics Issue
William Whitford, Thermo Fisher Scientific (USA)
John Donabauer, Abbott (USA) (TBC)
• What is the starting material?
• What data is sufficient?
• What are the QbD strategies being implemented
to complement current practices?
• What do you need to add to Q11?
Update on EFPIA Mock Submissions
Introduction to Workshops
12.30 – 13.30
Lunch and Networking Break
13.30 – 14.15
PQLI® Roadmap: Product Design,
Development, and Realisation, a Scienceand Risk-based Approach to Implementation
on Product Realisation
Ranjit R. Deshmukh, MedImmune (USA)
12.30 – 13.30
Lunch and Networking Break
13.30 – 15.15
Workshop 1 - Case Studies and Discussions
on Successfully Implementing ICH Q10 and
Topics in PQS
Joe Famulare, Genentech (USA); Rob Hughes,
Astra Zeneca (USA) (TBC)
• Key issues and solutions in implementing Q10
15.15 – 15.45
Break
15.45 – 17.30
Workshop 2 - A-Mab Case Study and Further
Developments in Applying QbD for
Biologicals
Beth Junker, Merk (USA) (TBC)
Sam Venugopal, PRTM (USA) (TBC)
• Key learnings from the case study
• Updates on implementing QbD
• What are the next steps?
17.30
Workshop 3 - Discussions on Using First
Principle Models, Multivariate Analysis to
Build, Describe Design Space and Manage
Control Strategies
Update on FDA Pilot Programme on QbD
Applications in Biotechnology
Speaker to be confirmed
• Update on small molecule case study
• Update on large molecule case study
• Key issues/ challenged from European team
members on QbD submissions
12.10 – 12.30
Review of Day 1, Introduction to Day 2
Steve Tyler, Abbot (USA)
• Introduction to the new guide
• PQLI progress and new initiatives
• Small molecule illustrative example and further
development work on AMAb large molecule case
study
14.15 – 15.00
Current Status of ICH Q11 Working Group
Pierette Zorzi, AFSSAPS (France) (invited)
• Progress with ICH Q11 draft
• What are the key issues?
• Implications that reflect back on how Q8,9,10 are
applied for API, biological drug substance
15.00 – 16.00
Panel Discussion, Questions and Answers,
Next Steps, Close of Seminar
Ranjit R. Deshmukh, MedImmune (USA)
Close of Day 1
Ranjit R. Deshmukh, MedImmune (USA)
17.45 – 18.45
Exhibition Networking Reception
ISPE 2010 Brussels Conference on Risk-based Control Strategies in Pharmaceutical Industries
www.ISPE.org/2010BrusselsConference
11
Containment: The Devil is in the Detail
22-23 September
Seminar Leaders:
Take Back to Your Job:
Richard Denk, Hecht Technologie (Germany),
• Understand that different toxicology limits are set for worker, product, and
Lisa Cardo, GSK (Italy)
The devil is in the detail. There is no more
appropriate expression in relation to containment.
During this two-day seminar, we will review the
critical points when planning a new containment
facility or modernising an already existing
manufacturing plant.
Topics covered during the seminar will include:
maintenance of containment transfer systems,
containment process systems, waste handling,
environmental protection
• Identify the critical areas for waste handling, maintenance, cleaning, and
interfaces on containment transfer systems
• Be aware of latest trends in containment
• Describe how other industry professionals solve containment challenges
• Understand the new technologies available and their impact on containment
and cross-contamination
Who Should Attend:
• Project, process or manufacturing engineers, environment and health and
and cross contamination and cleaning.
safety professionals, quality assurance, professionals from production or
Interfaces to other systems, such as filters and
manufacturing operations, professionals from process development, owners
quick couplings such as Tri Clamps round off
or operators, consultants, CMOs
the programme.
The seminar will also include a workshop allowing
Technical Documents:
participants to discuss various topics in small
groups. A specially-developed case study
• ISPE Baseline® Guide: Volume 1 – Active Pharmaceutical Ingredients
covering problems occurring frequently in
• ISPE Baseline® Guide: Volume 2 – Oral Solid Dosage Forms
industry will be used to focus the discussion.
• ISPE Good Practice Guide: Assessing the Particulate Containment
Afterwards, there will be a panel discussion with
subject-matter experts.
Performance of Pharmaceutical Equipment
• ISPE Knowledge Briefs
o Risk-based Approaches to Cross-contamination
Participants can expect an interactive seminar
o Containment Hierarchy of Controls
with a comprehensive insight into the world of
o Dry-powder Sampling and the Containment of Hazardous
containment.
Compounds
This seminar will provide an overview of powder
containment concepts as well as state of the art
engineering solutions.
Communities of Practice
(COPs):
API, Containment, Disposables, OSD, Product
Technical Knowledge and Competency
Elements:
A chart of the CPIPTM certification programme categories addressed by this
seminar is shown on page 3.
Seminar Content Level:
Process Development
Fundamental
12
●
Intermediate
ISPE 2010 Brussels Conference on Risk-based Control Strategies in Pharmaceutical Industries
www.ISPE.org/2010BrusselsConference
●
Advanced
Day 1
10.00 – 10.15
17.15 – 17.30
Lisa Cardo, GSK (Italy); Richard Denk, HECHT
Technologie GmbH (Germany)
Welcome and Introduction
Lisa Cardo, GSK (Italy); Richard Denk, HECHT
Technologie GmbH (Germany)
10.15 – 11.00
11.00 – 11.45
Day 2
Leonie Zimmermann, ZLG Bonn (Germany), invited
Visit www.ISPE.org/2010BrusselsConference for
updated session information.
09.00 – 09.15
High Containment for a Multipurpose OSD
Production
13.30 – 14.30
09.15 – 10.00
10.00 – 10.45
Lunch and Networking Break
Workshop on Two Case Studies Part I
Reduction of Airborne API, Decontamination
of Protective Clothing, Reducing Crosscontamination
Martin Axon, Safebridge (UK)
• The application of a fogging/misting shower in
production operations
• Differences between a fogging and a misting shower
• The potential for operator exposure and cross
contamination during protective clothing removal
due to presence of API on clothing surface
• The significant effects of the use of a fogging/
misting shower on airborne API and surface
contamination associated with protective clothing
Break
15.45 – 16.30
Containment by Isolators - A User's
Perspective
Abhay Gaitonde, Mylan India Private Limited (India)
• Traditional containment strategies
• Drawbacks and deficiencies
• Isolators in research and developement
• First steps toward real containment
• Isolators in manufacturing
• Setting up a state-of-the-art manufacturing
facility
• Future of containment
16.30 – 17.15
Concept for Efficient Handling of Highly Potent
APIs for the Manufacture of Solid Dosage
Forms – Dedicated Area for Sex Hormones
Hubert Bensmann, Haupt Pharma Münster GmbH
(Germany)
• Consistent high/closed design from dispensing of
API to coating of tablets
• Challenge between investment volume and
EHS/GMP requirements
• Risk-based approach for selection of equipment
• How to keep manufacturing costs under control
Case Study - Small Scale High Containment
API Production
Case Study – Philosophy and Rationale for a
State-of-the-Art Tablet High Containment
Facility
Lisa Cardo, GSK (Italy); Nicola-Maria Trivelli, GSK
(Italy)
• Philosophy and rationale for a state-of-the-art
tablet high containment facility
• Project planning and execution
• Installation and validation
• Challenges/decisions and lessons learned
10.45 – 11.15
Break
11.15 – 12.00
Case Study - Multiproduct Oral Solid Dosage
High Containment Facility (OEL 1µg/m3)
David Swift, CH2MHill (Ireland); John O’Loughlin,
Servier (Ireland)
• Equipment design - dispensing, granulation,
coating
• Containment transfer - split cone technology
• Facility design - architectural features and HVAC
design
12.00 – 13.00
15.15 – 15.45
Review of Day 1, Introduction of Day 2
Per Kronovall, Pharmadule (Sweden)
• Selecting the appropriate containment technology
for handling of potent compounds based on risk
assessment to avoid over-designing a facility or
operational procedures
• Impact of facility design, capital cost, lead time,
validation
• Comparison between barrier and isolator
technology
• Case study of a filling operation
• Regulatory view
Pam Davison, PJD Process (UK)
• Case study 1 - API multi-product
• Case study 2 - OSD multi-product
• Delegates form initial views based on knowledge
brought to seminar
14.30 – 15.15
Exhibition Networking Reception
Lisa Cardo, GSK (Italy); Richard Denk, HECHT
Technologie GmbH (Germany)
Production with Safe Handling of Highly
Active Compounds (OEL 40ng/m3)
Friederike Hermann, Lonza (Switzerland)
• How to develop a containment process in the
laboratory
• What it means to provide safe quality control in
the laboratory
• Surrogate testing and occupational hygiene
monitoring
12.30 – 13.30
17.45 – 18.45
Keynote - Regulatory View on Containment
Issues in Europe
Bernd Mümmler, Excella Pharma Source (Germany)
• Process and equipment design
• Product handling and operating procedures
• Personal protective equipment
11.45 – 12.30
Questions and Answers, Close of Day 1
Round Table Discussions
Richard Denk, HECHT Technologie GmbH
(Germany)
• Waste handling
• Product sampling
• Cleaning
• Containment transfer systems
13.00 – 14.00
Lunch and Networking Break
14.00 – 16.00
Workshop on Two Case Studies Part II
Pam Davison, Company (UK)
• Case study 1 - API multiproduct
• Case study 2 - OSD multiproduct
• Delegates reach conclusions based on knowledge
gained during the seminar
• Presentation of conclusions in plenary session
16.00 – 16.15
Questions and Answers, Close of Seminar
Lisa Cardo, GSK (Italy); Richard Denk, HECHT
Technologie GmbH (Germany)
ISPE 2010 Brussels Conference on Risk-based Control Strategies in Pharmaceutical Industries
www.ISPE.org/2010BrusselsConference
13
Investigational Products (IP): Lean and Compliant? Applying Efficient
Tools to a Regulated Clinical Supply Chain
22-23 September
Seminar Leaders:
Take Back to Your Job:
Bernd Steffens, Boehringer Ingelheim (Germany),
• Shared and developed experiences through workshops, networking and
Massimo Eli, MSD (Italy)
This seminar helps delegates understand and
develop new, lean and efficient ways along the
supply chain for IMPs while being compliant with
clinical trials regulations globally. Using case
development of best practice solutions to real problems
• State-of-the-art knowledge and understanding of issues facing IP
professionals
Who Should Attend:
studies and real examples the focus will be on
sharing experiences from the wide range of
• Those working in the fields of investigational products or clinical trials
companies involved in all supply chain activities
for investigational medicinal products.
Through a networking event, interactive
Technical Knowledge and Competency
Elements:
workshops and seminar presentations lead by key
opinion leaders within the industry, the seminar
A chart of the CPIPTM certification programme categories addressed by this
provides a valuable forum to challenge existing
seminar is shown on page 3.
preconceptions, demonstrate usage of new tools
and technology, explore alternative approaches
Seminar Content Level:
and to share “best practice” ideas.
The following topics will be amongst many
Fundamental
●
Intermediate
covered during this highly interactive two-day
seminar:
• Regulatory speakers from EMA focusing on the
GMP/GCP-interface
• Unique opportunity to provide direct feedback
to EMA on approaches agreed in one of the
interactive workshops to discuss GCP/GMP
interface
• VOC ‘Voice of the Customer’; Views and
perceptions from a clinical site
• Application of lean management tools
• IVR – technology and validation
• Using an ERP system to drive the clinical supply
process
• Managing and motivating clinical supply
personnel
Community of Practice
(COP):
Investigational Products
14
ISPE 2010 Brussels Conference on Risk-based Control Strategies in Pharmaceutical Industries
www.ISPE.org/2010BrusselsConference
●
Advanced
Day 1
10.00 – 10.15
Day 2
Welcome and Introduction
08.45 – 09.00
Bernd Steffens, Boehringer Ingelheim (Germany);
Massimo Eli, MSD (Italy)
10.15 – 11.00
11.00 – 11.45
11.45 – 13.00
Bernd Steffens, Boehringer Ingelheim (Germany);
Massimo Eli, MSD (Italy)
Keynote Speech Part 1 GMP/GCP Interface
Rebecca Harrison, MHRA (UK)
Visit www.ISPE.org/2010BrusselsConference for
updated session information.
09.00 – 09.15
Keynote Speech Part 2 GMP/GCP Interface
09.15 – 10.00
Philip Lange Møller, DKMA (Denmark)
Visit www.ISPE.org/2010BrusselsConference for
updated session information.
10.00 – 10.45
14.00 – 14.15
Summary Feedback from Interactive
Regulatory Forum
Clinical Supply at the Sharp End!
Views and Perceptions from a Clinical Site
Catherine Verbist, Brugmann Hospital Brussels
(Belgium)
• How do hospital pharmacy departments manage
clinical trials medication?
• What are the current challenges for clinical trials
pharmacists with trial medication?
• What strategies can be employed to create –
‘an ideal clinical trial pack’ for the site and the
patient?
15.00 – 15.45
10.45 – 11.15
Break
11.15 – 12.30
Workshops - Group 2
(delegates choose only one workshop out of three)
• Application of LSS in a Pharma and Contractor
Environment
Dianne McLaughlin, Aptuit (UK);
Nicolas Omdahl, Novo Nordisk (Denmark)
• A Toolbox for Virtual Clinical Supply Organisation
Marianne Oth, Eli Lilly (Belgium)
• Distribution Topic
Massimo Eli, MSD (Italy);
Karen Gram, Novo Nordisk (Denmark)
Approach to Validation for IVR Systems
Robert Smith, Genzyme (UK)
• Regulatory requirements for validation
• Processes to follow
• Case study/experience
15.45 – 16.15
16.15 – 17.30
Break
Introduction to Workshops
Bernd Steffens, Boehringer Ingelheim (Germany);
Massimo Eli, MSD (Italy)
12.30 – 13.30
Lunch and Networking Break
Workshops - Group 1
13.30 – 14.45
Workshops - Group 3
(delegates choose only one workshop out of three)
• Discussions on current regulatory topics including
Annex 13
Robert Smith, Genzyme (UK);
Sarbari Roy, Astra Zeneca (Sweden)
• Comparator medication/ non IMPs – Task Team
Esther Sadler-Williams, Aptuit (UK)
• Supply options for investigator sponsored studies
Peter Orosz, Boehringer Ingelheim (Germany)
17.30 – 17.45
• Choice of topics based on top three topics chosen
by delegates at beginning of Day 2
14.45 – 15.30
Case Study - An ERP (SAP) Based Fully
Integrated Solution to Plan, Control and
Execute the Corporate Clinical Supply Chain
Frank Altznauer, Roche (Switzerland)
• Enrolment driven material demand forecasting
• Regulatory and enrolment driven supply planning
and distribution execution
• Consolidated and fully integrated drug product
manufacturing planning
• Fully integrated patient kit production scheduling
and execution including capacity planning and
control
Questions and Answers, Close of Day 1
Bernd Steffens, Boehringer Ingelheim (Germany);
Massimo Eli, MSD (Italy)
17.45 – 18.45
How to Establish a Demand and Operations
Planning Process in the Clinical Supply Chain
Ann Dufton, GlaxoSmithKline (UK)
• Comparing and contrasting the benefits of D&OP
in a commercial supply chain with the needs of
the clinical trial supply chain
• The impact upon business processes, information
systems and ways of working
• The cultural change underpinning the introduction
of a D&OP process
• Managing the change process across the R&D
supply chain
• Case study (project example)
Bernd Steffens, Boehringer Ingelheim (Germany)
14.15 – 15.00
Implementing a Lean Mindset in CMC
Clinical Supplies
Nicolas Omdahl, Novo Nordisk (Denmark)
• How to drive the daily operations with a lean
structure
• How to stabilise processes and merge lean tools
with quality systems
• How to manage and improve the long term
business performance
Interactive Regulatory Forum
Lunch and Networking Break
Investigational Products – Communities of
Practice
Christine Milligan, Chair of EU IP COP, Fisher (UK)
• Break out into working groups
• Topic: Feedback for EMA on what IP professionals
should/could do differently tomorrow to better
support GMP/GCP interface
13.00 – 14.00
Introduction to Day 2, Audience Vote On
Workshop Topics for Workshop Session 3
Exhibition Networking Reception
15.30 – 16.15
Wildcard/Panel Discussion
Bernd Steffens, Boehringer Ingelheim (Germany);
Massimo Eli, MSD (Italy)
16.15 – 16.30
Voting Session on Themes for 2011,
Questions and Answers, Close of Seminar
Bernd Steffens, Boehringer Ingelheim (Germany);
Massimo Eli, MSD (Italy)
ISPE 2010 Brussels Conference on Risk-based Control Strategies in Pharmaceutical Industries
www.ISPE.org/2010BrusselsConference
15
Science and Risk-based Commissioning and Qualification (C&Q):
Transitioning and Transforming
22-23 September
Seminar Leaders:
Communities of Practice (COPs):
Gert Mølgaard, NNE Pharmaplan (Denmark)
C&Q, GAMP, Project Management
Outlining science and risk-based methodologies
for planning and implementing a project through
Take Back to Your Job:
the entire lifecycle, this seminar includes case
studies and workshops to help you gain a
• Understand and apply QRM principles to C&Q
working knowledge of the ISPE Baseline® Guide:
• Deliver projects more efficiently using lean risk-based applications
Science and Risk-based Approach for the
• Understand how to apply risk-based principles within your organisation
Delivery of Facilities, Systems, and Equipment.
based on knowledge obtained through case studies and workshops
• Understand regulatory perspectives and expectations
The two-day seminar will outline science and riskbased methodologies for planning and
implementing a project through the entire life
• Analyse applications through case studies and how this knowledge can
be applied to your company
• Gain insights into problem solving by applying concepts in the Guide
cycle. It will feature the newest concepts and
exemplify their applications in a way that you can
use in your company.
Who Should Attend:
• How to incorporate Quality Risk Management
C&Q crosses over most pharma manufacturing professionals but will be
(QRM) principles (e.g., QbD, risk assessments,
especially important for Commissioning and Qualification (Validation)
control strategies, product/ process knowledge,
professionals as well as design GAMP practitioners, engineers, project
etc.) into C&Q activities and deliverables (e.g.,
managers, construction managers, and quality managers who need to
requirements definition, design review, C&Q
understand and follow GEPs in order to design and deliver projects utilising
planning, verification, test and release)
risk-based approaches.
• Real-world implementation of risk-based
approaches to fit your company’s needs (efficient
use of GEP commissioning data and vendor
documentation based on identified risk factors)
• Managing and documenting engineering/project
change
• Verification processes for demonstrating
fit-for-intended use
• Understanding, defining, and assigning roles
Related Technical Documents:
• ISPE Baseline® Guide: Volume 5 – Commissioning and Qualification
• ISPE Baseline® Guide: Volume 12 – Science and Risk-based Approach for the
Delivery of Facilities, Systems, and Equipment
• ICH Q9
• EU GMP Guide, Annex 15
• ASTM E2500-07
and responsibilities for a risk-based project,
and building confidence in the process
Come and participate in discussions with the
Guide writers, case study presenters, and your
Technical Knowledge and Competency
Elements:
colleagues who also intend to implement this
A chart of the CPIPTM certification programme categories addressed by this
new approach. For those less experienced, an
seminar is shown on page 3.
introductory webinar will be available in advance
of the seminar at no additional charge, so that
you can better take advantage of this
intermediate to advanced seminar.
16
Seminar Content Level:
Fundamental
●
Intermediate
ISPE 2010 Brussels Conference on Risk-based Control Strategies in Pharmaceutical Industries
www.ISPE.org/2010BrusselsConference
●
Advanced
Day 1
10.00 – 10.15
Day 2
Welcome and Introduction
09.00 – 09.15
Gert Mølgaard, NNE Pharmaplan (Denmark);
Joerg Block, Bayer Healthcare (Germany)
10.15 – 11.15
Introduction to ISPE Baseline® Guide: Volume
12 – Science and Risk-based Approach for
the Delivery of Facilities, Systems, and
Equipment
Steve Wisniewski, IPS (USA)
• Background
• Overview of the process
• Content of the Guide
11.15 – 12.45
Gert Mølgaard, NNE Pharmaplan (Denmark);
Joerg Block, Bayer Healthcare (Germany)
09.15 – 10.00
Lunch and Networking Break
13.45 – 15.15
Application of Quality Risk Management
(QRM) Principles to Assure Equipment
Fitness for Use and Process Sustainability
for Manufacturing Operations
10.45 – 11.15
Break
11.15 – 12.00
Application of ASTM E2500 to a Coating Pan
Verification Study
Speaker to be confirmed, Pfizer (Belgium)
• Pfizer’s ASTM E2500 implementation project
• Case study - saving paper, time and money by
applying ASTM E2500-based verification
• Challenges and lessons learned
12.00 – 12.45
Petter Gallon, AstraZeneca (Sweden)
• Practical application of quality risk management
• Quality by design principles
• Case example
15.15 – 15.45
Break
15.45 – 16.30
Construction Quality, Commissioning and
Qualification - The Keys to Time-to-Market
Jay Lad, SPGL Ltd (Formerly Skanska
Pharmaceutical Group) (UK);
Stig Bochman-Perdersen, GSK Biologicals
(Belgium)
• Why does it take the pharmaceutical industry
longer to deliver capital projects?
• What are the challenges from a construction/field
execution perspective?
• What can a clear C&Q/Verification strategy,
underpinned with a good Construction Quality
Management Programme accomplish?
16.30 – 17.45
Johnson & Johnson Packaging Line - Case
Study and Workshop
Michael O’Neal, Johnson&Johnson (USA);
Machteld Deconinck, Johnson&Johnson (Ireland)
• Implementation of Science and Risk-based
Qualification (ASTM E2500)
• Case study
• Evaluation of benefit and challenges
17.45 – 18.45
EU Regulatory Perspective on Risk-based
C&Q
Ian Thrussell, MHRA (UK)
• European regulatory requirements
• Verification in an Quality by Design environment
• Update on European trends
Risk Assessment Methodologies and
Workshop
12.45 – 13.45
FDA Regulatory Perspective on Risk-based
C&Q
Speaker to be confirmed
Visit www.ISPE.org/2010BrusselsConference for
updated session information.
10.00 – 10.45
Tim Howard, Commissioning Agents Inc (USA)
• Application of risk management from conceptual
design development to final design review
• RA tools best suited to each step in the process
• Leveraging output of RA for verification
• Workshop on the application of tools and design
high-risk areas
Review of Day 1, Introduction to Day 2
Partnering with Vendors: Bayer Health Care
Global 2-D Matrix Programme - Standard
Equipment Qualification Case
Joerg Block, Bayer Schering (Germany)
• Coordinated equipment qualification approach for
a global programme
• Implementation of ASTM 2500 and GAMP® 5
concepts
• Cooperation with vendor and integration of
vendor documentation
12.45 – 13.45
Lunch and Networking Break
13.45 – 15.45
Workshop: Applying a Top Down Approach
to Verification via Critical Aspects
Armen Nahabedian, Pfizer (USA)
• The new science and risk-based approach to
verification relies on identification of critical
aspects for manufacturing systems. Via small
group interactive exercises, this workshop will
show how to develop critical aspects by starting
from process and product requirements. A
standard CIP system will be used to illustrate and
apply the concepts.
15.45 – 16.15
Questions and Answers, Close of Seminar
Gert Mølgaard, NNE Pharmaplan (Denmark);
Joerg Block, Bayer Healthcare (Germany)
Exhibition Networking Reception
ISPE 2010 Brussels Conference on Risk-based Control Strategies in Pharmaceutical Industries
www.ISPE.org/2010BrusselsConference
17
Sterile Drug Manufacturing Facilities:
Applying ISPE Baseline® Guide and USFDA Guidance Principles
to Design and Operation
This course references ISPE's Sterile Manufacturing
Facilities Baseline® Guide and the USFDA's newly
published Guidance for Industry: Sterile Drug Products
Produced by Aseptic Processing - Current Good
Manufacturing Practice. Both of these documents help
provide an understanding of the key requirements
and GMPs for sterile manufacturing facilities. The
Baseline Guide provides valuable information on
design, construction, and commissioning and
qualification while the FDA's new Guidance helps
professionals understand the regulatory context and
expectations for sterile drug manufacturing.
Using the referenced documents, this course will
cover regulatory philosophy, aseptic process and
equipment considerations, aseptic clean room design
and operation, differential pressure requirements,
airlocks, basic utility systems, European HVAC
considerations, basic commissioning and qualification
issues, and a brief introduction to barrier isolation
technology. (Note: parts of Guidance for Industry:
Sterile Drug Products Produced by Aseptic
Processing - Current Good Manufacturing Practice
that do not focus on facilities and equipment will
not be discussed in detail.)
In addition, the course will include an exercise in the
layout of an aseptic filling facility. In many cases,
when a new facility is required within an existing or
new building, the designer will begin by sketching a
floor plan. This exercise will demonstrate how to use
process flow diagrammes and an accommodation
schedule to thoroughly define facility requirements
before advancing to the floor plan layout stage.
Participants will receive a complimentary copy of the
Sterile Manufacturing Facilities Baseline® Guide.
Who Should Attend:
• Engineers, validation scientists, quality assurance
specialists, and manufacturing managers
• Professionals who want a fundamental
understanding of sterile manufacturing facilities
and their design, renovation, and operation
• Engineering firm professionals and other
consultants who work with the pharmaceutical
industry
Community of Practice
(COP):
22-23 September • CEUs: 1.3
Take Back to Your Job:
• Identify sources of contamination in aseptic
operations
• Explain methods for contamination control
• Describe the major requirements for design, renovation, and operation of a
sterile manufacturing facility
• Discuss the fundamentals of aseptic clean room design
• Understand the importance of monitoring critical parameters: temperature,
humidity, air velocity, differential pressure, airflow patterns, non-viable particle
counts, and microbial counts
• Design a systematic process for aseptic facility layout
• Apply ISO 14644, Clean Rooms and Associated Controlled Environments Part 1: Classification of Air Cleanliness to Aseptic Processing Clean Rooms
• Discuss the difference between U.S. and European clean room HVAC standards
• Distinguish between the 2004 and 1987 versions of the FDA's Guidance for
Industry, Sterile Drug Products Produced by Aseptic Processing - Current Good
Manufacturing Practice as applied to the design, operation, maintenance, and
modification of facilities
Instructor Biography:
Gordon Farquharson, BSc (Hons), CEng is a Chartered Consulting Engineer with
more than 30 years of experience in quality and safety critical processes and
facilities used by industries such as healthcare, life science, micro-electronics, etc.
He is Principal of Critical Systems Ltd, an international consultancy business.
Farquharson has been responsible for the development of technical solutions in
discovery, research, product/process development, primary manufacturing, and
device and dosage form manufacturing. Standards and regulatory compliance in
the sector are a significant interest and responsibility. He is Chairman of UK BSI
and CEN Technical Committees for cleanroom standards, Convenor of the ISO
working group that is revising ISO 14644-1 and 2. He has recently represented
ISPE and CEN, working on the EMEA’s revision of Annex 1 of the EU GMP. He
has also supported ISPE by writing WHO’s new Pharmaceutical Water GMP
Guidance, and has been active developing and revising ISPE Baseline® Guides.
Farquharson is a past chair of the ISPE European Education Committee and
current member, a founder of the Sterile Products Processing COP, and was
voted ISPE International Member of the Year in 2001, UK Affiliate Member of
the Year 2008, and received the Richard B. Purdy Distinguished Achievement
Award in 2009. He is a frequent speaker and trainer for ISPE worldwide.
Technical Knowledge and Competency
Elements:
Please see explanation of CPIP on page 3 along with a chart of the categories
addressed by this course.
Course Content Level:
Fundamental
●
Sterile Products Processing
18
ISPE 2010 Brussels Conference on Risk-based Control Strategies in Pharmaceutical Industries
www.ISPE.org/2010BrusselsConference
Intermediate
●
Advanced
Practical Application of Computerised Systems Compliance
Applying the GAMP® 5 Guide: A Risk-based Approach
to Compliant GxP Computerised Systems
This highly interactive workshop gives participants
hands-on experience in applying practical
22-23 September • CEUs: 1.5
Who Should Attend:
techniques and solutions to solve computerised
• Quality assurance and quality control specialists, validation specialists,
systems compliance challenges. Participants will
manufacturing supervisors, technical support personnel, engineers,
discuss and analyse case studies, apply newly
MIS professionals, and all levels of management who need a practical
acquired knowledge to hypothetical case-study
systems, and have the opportunity to discuss their
own real-life challenges with other participants
and an expert trainer. Participants should come
understanding of computerised systems compliance
• Computer systems vendors or consultants, engineering contractors,
and validation service companies
• Those who have previously attended a GAMP Basic Principles training
prepared to work in groups to devise workable
course or those whose practical experience has provided the equivalent
and creative solutions to realistic problems and
level of knowledge
case study scenarios, facilitated by the instructor.
Participants will receive a complimentary copy of
the GAMP® 5 Guide: A Risk-based Approach to
Compliant GxP Computerised Systems.
Take Back to Your Job:
• This training course is of particular interest to existing and future members
of the ISPE GAMP Community of Practice (COP)
Instructor Biography:
Sion Wyn, Director, Conformity Ltd., is an acknowledged expert in computer
system validation and compliance and international regulations in this field.
He is currently assisting the FDA with its re-examination of 21 CFR Part 11,
• Overview of key themes and concepts in
GAMP® 5
• Understanding the process and overall GxP Risk
• Effective planning for compliance
• Supplier assessment and leveraging supplier
knowledge and documentation
• The key role of clear and complete user
requirement specifications
• Choosing a suitable specification and
verification approach
• GAMP 5 Quality Risk Management approach
(based on ICH Q9)
and is a member of the team that produced the FDA Guidance on 21 CFR
Part 11 Scope and Application. He is the technical content expert for the
FDA’s ORA Virtual University online training modules on computerised systems
validation and compliance. He has received the FDA Group Recognition Award
for work on Part 11. Wyn is the editor of ISPE’s GAMP® 5 Guide - A Risk-based
Approach to Compliant GxP Computerised Systems, and is a member
of the ISPE GAMP Council, GAMP Editorial Board, and the GAMP Europe
Steering Committee. At Conformity Ltd., Wyn provides computer validation
and compliance consultancy to the pharmaceutical and other regulated
healthcare industries. Wyn received the 2006 ISPE Professional Achievement
Award, which honours an ISPE Member who has made a significant
contribution to the pharmaceutical manufacturing industry.
• Specific risk assessment tools for computerised
systems
• Selecting a suitable lifecycle and scaling the
lifecycle based on risk, complexity, and novelty
• Developing a strategy and writing a
computerised system validation plan
• Writing high-quality test scripts
• Maintaining the control in operation –
a scaleable approach
• Regulatory hot topics
Technical Knowledge and Competency
Elements:
Please see explanation of CPIP on page 3 along with a chart of the categories
addressed by this course.
Course Content Level:
Fundamental
●
Intermediate
●
Advanced
Community of Practice
(COP):
Good Automated Manufacturing Practice
(GAMP)
ISPE 2010 Brussels Conference on Risk-based Control Strategies in Pharmaceutical Industries
www.ISPE.org/2010BrusselsConference
19
General Information
Registration Fees include conference or training materials,
refreshment breaks listed in the programme, lunches, exhibition
networking receptions and exhibition access.
Always keeping our global impact in mind, ISPE finds ways to
conserve resources at its Conferences. Instead of printing education
session handouts, ISPE now makes them available online for
convenient, 24/7 access. Not applicable for the training courses.
If you wish to become a Member of ISPE and benefit from lower
registration fees, please select New Member registration fees.
€200 (VAT exempt) for your one-year membership is included in
the New Member fees. If you do not wish to become a Member of
ISPE, please select the Non Member fees. Your application must be
returned within 30 days in order to activate your membership.
ISPE membership is individual, and must be paid in full to qualify for
the Member fee. If you have questions regarding your membership
status, please contact ISPE by telephone: +32 2 743 44 22 or by
fax: +32 2 743 1584.
Payment: Payment must accompany the registration form.
Registration will not be processed nor confirmed without payment
in Euro (€). All registrations sent by fax must include the necessary
payment information – please complete the relevant spaces and
sign the registration form. American Express, Visa and MasterCard
are accepted.
Early Registration Deadline: To benefit from the early registration
fee, payment must be received on or before 13 August 2010. After
this date the standard registration fee will be applied.
Confirmation: Upon receipt of payment, a proof of payment will be
sent to you, along with your confirmation letter (time permitting).
Hotel accommodation is not included in the registration fee. You will
need to present your registration confirmation letter at the ISPE
Registration Desk at the Sheraton Brussels Hotel. You will receive
your conference name badge at that point.
If you do not receive a registration confirmation letter, please
contact: ISPE Registration Services, Avenue de Tervueren, 300,
B-1150 Brussels, Belgium. Email: europeregistrations@ISPE.org,
Fax:+322743 1584
In order to be listed in the official delegate roster, you must have
registered for the conference and paid by 3 September 2010.
Cancellation Policies: Full refunds, less a handling fee of €100 per
registrant, will be granted to requests received in writing before or
on 3 September 2010. No refunds will be granted for requests
received after 3 September 2010. Telephone cancellations are not
accepted.
Liability: ISPE reserves the right to cancel or reschedule any
conference and/or to change speakers or instructors. Please be
advised that ISPE is not responsible for any airfare/hotel penalties
or other travel charges you incur. In case of government
intervention or regulation, military activity, strikes or other
circumstances that make it impossible for the conference to go
ahead at the time and place provided, the participant shall waive
any claim for damages or compensation except the amount paid
for registration after deduction of actual expenses incurred in
connection with the conference. There shall be no future liability on
the part of either party.
Substitutions: If a delegate is unable to attend, substitutions will
be accepted; however Nonmembers substituting for Members must
pay the difference if fees prior to the start of the event. ISPE cannot
be held responsible for loss of airfare or other travel costs due to
cancellation.
ISPE Speakers: The speakers invited to present ISPE programmes
are leading professionals within their respective fields. Should it be
necessary, we will make substitutions. Every precaution is taken to
ensure accuracy, but ISPE cannot accept responsibility for the
accuracy of information distributed or contained in these
programmes, or for any other opinion expressed.
Group Discounts: Group discounts apply; see the registration form
for details. Discounts cannot be combined and Member and
Nonmember pricing applies. Group registrations must be submitted
at the same time. Substitutions will be accepted. To benefit from a
group discount, please fill in a group registration form, available
from www.ISPE.org/2010BrusselsConference.
Emerging Economy Countries Discount: ISPE offers a 50%
discount on the normal early/late registration fees to Members
from Emerging Economy countries. Visit
www.ISPE.org/EmergingEconomyList to find out more. The
discount will automatically apply when your registration is
processed.
Student Discount: To qualify for the student registration rate for
training courses, you must be a Student Member of ISPE. This rate
applies to individuals enrolled full-time at a college, university or
other educational institution.
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considerations – please attach a written description of your needs
with your registration form. If you have any questions, email:
europeregistrations@ISPE.org.
About the Conference Hotel
Sheraton Brussels Hotel
Place Rogier 3, B-1210 Brussels, Belgium
Tel: + 32 2 224311
Fax: +32 2 2243456
www.starwoodhotels.com/sheraton
Room rates
Single room: 185 €
Double room: 210 €
Rates include 6% VAT, 10% city tax, 16% service charge
and buffet breakfast.
ISPE has secured a number of bedrooms at this fixed group rate for your convenience. All accommodation bookings must
be made directly with the hotel and are subject to availability. To benefit from the ISPE group rate, reservations must be
received before 1 September 2010 through the booking link at www.ISPE.org/2010BrusselsConference/hotel.
20
ISPE 2010 Brussels Conference on Risk-based Control Strategies in Pharmaceutical Industries
www.ISPE.org/2010BrusselsConference
Please return to: ISPE Registration Services
Avenue de Tervueren, 300 • B-1150 Brussels, Belgium
Tel: + 32 2 743 44 22 Fax: + 32 2 743 15 84
Email: europeregistrations@ispe.org
Registration Form
Blabla
SAVE TIME – REGISTER ONLINE: www.ISPE.org/2010BrusselsConference
I. Delegate Information
Prefix: ___________ First Name:______________________________________________ Last Name:______________________________________________________________________
Job Title: _________________________________________________________________ Company: ______________________________________________________________________
Address:__________________________________________________________________________________________________________________________________________________
City: _____________________________________________________________________ Postal Code: _______________ Country: _____________________________________________
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Mobile: __________________________________________________________________ Email: __________________________________________________________________________
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❑ 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 – 21% Belgian VAT is applicable on registration and networking evening fees only.
Are you an ISPE Member? ❑ Yes , membership number: ______________________ ❑ No
If you wish to become a Member of ISPE and benefit from lower registration fees, please select New Member registration fees. €200 (VAT exempt) for your one-year membership
is included in the New Member fees indicated below. If you do not wish
to become a Member of ISPE, please select the Non Member fees.
❑ Tick here if you are a first time attendee
Payment received on
or before 13 August 2010
Payment received after
13 August 2010
Member
New
Member
Non
Member
Member
New
Member
Non
Member
❑ Full conference package: select two seminars below –
one per two-day series - and save 20% on the second seminar.
€1.935
€2.135
€2.245
€2.235
€2.435
€2.560
❑ Seminar package: select one seminar below.
€1.075
€1.275
€1.340
€1.375
€1.575
€1.655
Seminars: Monday 20 – Tuesday 21 September
Seminars: Wednesday 22 – Thursday 23 September
❑ Barrier Isolation Technology Forum:
Innovation, Updates, New Case Studies
❑ Containment: The Devil is in the Detail
❑ Dedicated Facilities, Cross Contamination and the Risk-MaPP
Approach
❑ Investigational Products (IP): Lean and Compliant? Applying
Efficient Tools to a Regulated Clinical Supply Chain
❑ GAMP®: A Guided Tour of the World
of Good Practice Guides
❑ Science and Risk-based Commissioning and Qualification:
Transitioning and Transforming
Please note that academia,
emerging economy,
government and student
Members benefit from
discounts on the
registration fees.
For further details
please contact
ISPE Registration
Services at
Tel: + 32 2 743 44 22
or email:
europeregistrations@ispe.org
❑ PQLI®: Case Studies in QbD for Biotechnology and
Small Molecule Product Realisation
Payment received on or
before 13 August 2010
Payment received after
13 August 2010
Member
New
Member
Non
Member
Member
New
Member
Non
Member
❑ Sterile Drug Manufacturing Facilities: Applying ISPE Baseline®
Guide and FDA Guidance Principles to Design and Operation
€1.510
€1.710
€1.795
€1.810
€2.010
€2.110
❑ Practical Application of Computerised Systems Compliance GAMP® 5
€1.610
€1.810
€1.900
€1.910
€2.110
€2.215
Training courses
€65 / person. Accompanying partners are welcome to attend this
event (same fee applies).
Networking Evening, Wednesday 22 September
III. Method of Payment
(21% Belgian VAT must be included in the total payment,
excluding €200 membership fee on New Member registrations)
Seminar Fees
Subtotal
21% VAT
€ _________________
€ _________________
€ _________________
Total Due:
€ _________________
❑ Credit Card
❑ AMEX
❑ Visa
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Credit Card Number: ______________________________________________________________ Expiry Date: ________________________
Cardholder’s Name: ____________________________________________________________________________________
Signature:
IV. Special Needs (dietary or other): _______________________________________________________________
V. Hotel Information
A block of rooms has been reserved at the venue:
Sheraton Brussels Hotel, Place Rogier, 3 - 1210 Brussels, Belgium
http://www.starwoodhotels.com/sheraton/ — Tel: +32 2 22 43 11 — Fax: +32 2 22 43 456
Single Room (€185) Double Room (€210)
(Rates include 6% VAT, 10% city tax, 16% service charge and buffet breakfast.)
ISPE has secured a number of bedrooms at this fixed group rate for your
convenience. All accommodation bookings must be made directly with the hotel
and are subject to availability. To benefit from the ISPE group rate, reservations
must be received before 1 September 2010 through the dedicated booking link
available at www.ISPE.org/2010BrusselsConference/hotel
VI. Signature By signing I agree with the ISPE Registration and Cancellation Policies (see www.ISPE.org/2010BrusselsConference)
Date: ___________________________________
Signature:
2010 Brussels Conference • 20-23 September 2010
Blabla
Risk-based Control Strategies in Pharmaceutical Industries
PROGRAMME AT-A-GLANCE
Date
Conference Seminars
Monday
20 September
Tuesday
Barrier Isolation
Technology Forum:
Innovation, Updates,
New Case Studies
Dedicated Facilities,
Cross Contamination
and the Risk-MaPP
Approach
21 September
Wednesday
22 September
Thursday
Containment:
The Devil is
in the Detail
23 September
GAMP:
Guided Tour
of the World of
Good Practice
Guides
Investigational
Science and
Products (IP):
Risk-based
Lean and Compliant? Commissioning and
Applying Efficient Qualification (C&Q):
Tools to a Regulated Transitioning and
Clinical Supply Chain
Transforming
Training Courses
Network
Events
Exhibition
Networking
PQLI®:
Case Studies
in QbD for
Biotechnology
and
Small Molecule
Product Realisation
Sterile Drug
Manufacturing
Facilities: Applying
ISPE Baseline® Guide
and FDA Guidance
Principles to Design
and Operation
Practical
Application of
Computerised
Systems
Compliance
GAMP® 5
Exhibition
Networking
Mark your Calendars
for 2010-2011
Training Workshops for ICH Q8, Q9 and Q106
8 October 2010 • Washington, DC
ISPE Annual Meeting
Sponsorship and Table Top
Exhibit Opportunities
avaible now!
7-10 November 2010 • Orlando, Florida • USA
ISPE Tampa Conference
22-25 February 2011 • Tampa, Florida • USA
For more information on ISPE education offerings, including
conferences, training, webinars, publications and more,
Visit the Conference Web site
for more information.
www.ISPE.org/2010BrusselsConference
visit www.ISPE.org
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