This document provides information about the ISPE Singapore Conference and Exhibition on Continuous Improvement in the Life Science Industry taking place from June 22-24, 2014 at the Suntec Singapore Convention & Exhibition Centre. The conference will feature keynote speeches, workshops, and an exhibition on various topics related to pharmaceutical manufacturing. Attendees can choose from various packages including access to workshops, presentations, networking events, and plant tours. The conference is aimed at professionals working in areas such as biomanufacturing, facilities, quality assurance, and more.

1. 22 - 24 June 2014 • Suntec Singapore
CONFERENCE AND EXHIBITION
Continuous Improvement in the Life Science Industry
NEW! ISPE Singapore’s dedicated Exhibition
integrated with the Conference
Take your pick from Keynote plenary sessions,
technical workshops and tracks
Learn from international and regional
experiences, process and technology
innovations
Gather latest techniques and solutions from
technology providers and experts
Meet your peers and expand your network
of manufacturing professionals
Continuous Improvement in the Life
Science Industry
ISPE Singapore Conference isYOUR industry
event. Developed by your industry peers,
the programme and educational platform
addresses the region’s pressing
pharmaceutical manufacturing issues,
relevant to both multinational
and regional manufacturers.
MAXIMISE YOUR TIME @
ISPE SINGAPORE
90% NEW & 50% MORE speakers
36 hours of LEARNING
Over 34 presenters from 10 countries
9 PRACTICAL WORKSHOPS
At least 6 NETWORKING hours
1 PLENARY Keynote session
PLUS
ISPE Exhibition of Latest technology & innovations
www.ispesingapore.org
YOUR industry’s
annual meeting for
pharma &
biomanufacturing
WELCOME!
The ‘New-look’ ISPE
Singapore
Co-organised by
Scan this QR Code with
your smartphone to
view online and register

2. Operational Excellence & Lean Manufacturing
Through Single-Use Technologies
MinhTran, TechnologySpecialistGroupManager(Asia
Pacific), Single Use Processing, Merck Millipore
ISPE Singapore Conference 2014
Continuous Improvement in the Life Science Industry
Session Times SUNDAY • 22 JUNE
1330 – 1730
CONCURRENT WORKSHOPS
Workshop A: Quality / Validation Workshop B: Operational Excellence Workshop C: Bio / Sterile / Clean Utilities
Cleaning Validation Workshop
John Hyde, Chairman & Founder, Hyde Engineering
+ Consulting, USA
Value Stream Mapping in an Engineering Context
John Guerin, GeneralManager, ZenithTechnologies,
Singapore & Bryan McSwiney, Global Chief
Technology Officer, Zenith Technologies, Ireland
Cross Industry Expertise in Filtration, RO, Purified
Water and Water for Injection
Mike Gaunt, Technology Manager – Pharmaceutical
Process Water, Veolia Water Solutions &
Technologies, UK
MONDAY • 23 JUNE
PLENARY KEYNOTE SESSIONS
0900 – 0915 Welcome Address
Pierre Winnepenninckx, President, ISPE Singapore Affiliate
0915 – 1000 Update on“Office of Pharmaceutical Quality,”What’s New in CDER and How it Affects Your Process
Janet Woodcock, Director, FDA/DHHS/Accounting Operations, USA, Video Presentation
1000 – 1045 Developments in Asia Pacific – GMP Update and Outlook
Bob Tribe, Former Chairman of PIC/S & Asia Pacific Regulatory Affairs Advisor, ISPE
1045 – 1130 Opening of ISPE Singapore Exhibition & Plenary Networking Refreshments
1130 – 1210 Planning Considerations for Stelis Biopharma’s First Single Use Manufacturing Facility in Asia
Jagmohan Satischandra, VP, Engineering & Projects, Stelis Biopharma, Malaysia
1210 – 1245 PANEL DISCUSSION: Under the Microscope: The Biomedical Landscape 2014
Moderator: Simranjit Singh, Chairman, BioSingapore
Panelist: Ajay Sangeria, Director, PwC
Christopher Langwallner, CEO, Namz
Chris McNamara, Executive Director, MERCK
1245 – 1400 Conference Networking Lunch
Workshop D: Tech Transfer / Process Validation Workshop E: QBD / PAT Workshop F: Sterile Operations
1400 – 1445
Analytical Validation in the Context of a
Technology Transfer
Dr Ludwig Huber, Director and Editor,
Labcompliance, Germany
Mitigating Risk and Implementing QbD with Real
Time Process Monitoring of Pharma, Bio-Pharma
Processes
Saby Goswami, Asia Sales Manager, Umetrics
Retrofitting/Upgrading Containment Equipment
to Eliminate PPE
XLLin, MarketDevelopmentDirector/GeneralManager
– Pharma/Containment – Singapore, Esco Group
1445 – 1530
Scale Up & Tech Transfer for Single Use
Technologies
Suyamburam Sathasivam, Head of Technical
Operations, Stelis Biopharma, Malaysia
Learnings for Quality-by-Design (QbD) from aTotal
Quality Management (TQM) Perspective
Dr Chew Wee, Research Scientist, Institute of Chemical
& Engineering Sciences, A*STAR, Singapore
Methods and Application Examples of Room
Pressure Control in Cleanrooms
Mitsuru Saito, Okaya Seiritsu Engineering
Co Ltd, Japan
1530 – 1615 Afternoon Networking Refreshments in Exhibit Hall
1615 – 1700
The Use of Integrated Mass Spectrometer as PAT
Tool – In-line Process Monitoring and Detection of
Silicon Oil Leakages
Uwe Meissner, BusinessDevelopmentandApplications
Manager, MKS Instruments Analytical Solution
Group, Germany
Single Use Technology: A Customer Viewpoint
Jagmohan Satischandra, VP, Engineering & Projects,
Stelis Biopharma, Malaysia
1700 – 1745
Retroactive Design Space Characterization
Through CPP/CQA Relationships and Control
Strategy (Considerations for Transferring Legacy
Products)
JohnWass, ProjectManager, Commissioning Agents
International, Inc., USA
QbD – Overview on Principle and Regulatory and
Industry Activities
Dr Ludwig Huber, Director and Editor,
Labcompliance, Germany
Rouge – Is it an Acceptable Surface Condition?
Dr Lorenz Egli, Director, Life Sciences Division,
Borer Chemie AG, Switzerland
1745 – 1900 PharmaNite Networking
TUESDAY 24 JUNE
Workshop G: Quality / Audit / Regulatory
Workshop H: Operational Excellence / Lean
Manufacturing Workshop J: Biologics
0900 – 0945
Conducting A Remote Audit
Danny Tan, Global GMP Compliance Audit Manager,
F. Hoffmann-La Roche, Singapore
Designing – Lean Manufacturing Facility:
Manufacturers' Perspective
Sujit Kinge, Associate Director (Operations) &
Srinivas Yedavalli, Project Quality Lead,
Merck Sharp & Dohme GmbH Ltd, Singapore
The Application of Good Project Management
Skills to the C&Q Phase of Projects
Peter Roche, Projects Manager, Singapore & Declan
O’Shea, SeniorCommissioning&QualificationEngineer,
PM Group
0945 – 1030
Cleanroom HVAC Turndown – Experimental Data
and Regulatory Challenges
Ashley Isbel, Lead Consultant, PharmOut, Australia
Paperless Manufacturing, a Lean Opportunity for
Batch Recording
David Margetts, Managing Director & Co-Founder &
Teerapong Cheepchol, Deputy Managing Director,
Factorytalk, Thailand
1030 – 1100 Morning Networking Refreshments in Exhibit Hall
1100 – 1145
The European Falsified Medicines Directive & its
Implications for Manufacturers in Asia Pacific
Dr Vee Revithim, Head of External Relations Europe,
F. Hoffmann-La Roche, Switzerland
Dispensing and Blending of High Potency Active
Pharmaceutical Ingredients (HPAPIs) for Tablet
Press Feeding
Frédéric Dietrich, Managing Director,
Dietrich Engineering Consultants, Switzerland
High Containment Powder Handling –
Considerations for Reducing Risk and Increasing
Performance
Michael Avraam, Global Product Manager,
ChargePoint Technology Ltd, UK
1230 – 1330 Workshops Lunch
Latest Trends in Data Integrity Observations
During Regulatory Inspection: A Multi Regional
and International Perspective
Ashley Hankinson, Managing Director, Global
Compliance International, Singapore
1145 – 1230
1330 – 1500
TPM Implementation Workshop
Samuel Ong, TMP Program Manager, Novartis
Singapore
1500 – 1530 End of Workshops followed by Afternoon Networking Refreshments in Exhibit Hall
Tank Design for Pharma –WhatYou Need to Know
Pierre Winnepenninckx, Managing Director,
No deviation Pte Ltd / President, ISPE Singapore
Affiliate
Handling Regulatory GMP Inspections
Bob Tribe, Former Chairman of PIC/S & Asia Pacific
Regulatory Affairs Advisor, ISPE
www.ispesingapore.org

3. ISPE Singapore is for YOU!
Vice Presidents, Directors, General Managers, Plant
Managers, Heads of Departments, Managers, Group /Team
/ Project Leaders, Senior Scientists, Engineers, Development
and Technical / Application, Specialists, Site and Project
Directors, Quality Control / Quality Assurance, Professors
involved in:
• Biomanufacturing
• Facility Development
• Plant Commissioning & Qualification
• Process Validation
• Process Development
• Process Engineering
• Upstream Processing
• Downstream Processing (Purification)
• Technical Operations
• Regulatory Compliance / Affairs
• Quality Assurance / Control
From:
• Biopharma Manufacturers
• Vaccine Companies
• CMOs
• Medical Device / Medtech Manufacturers
• Biotechs
• Research and Academic Institutions
• Technical Service Providers
• Engineering & EPCM Companies
• Equipment and Technology Providers
• Analytical equipment & services
• APIs
• Automation and IT systems
• Bio-solution for Pharma
• Bioinformatics
• Biopharmaceutical / Biotechnology
• Clean Room Equipment & Supplies
• Commissioning & Qualification
• Contract Services & Outsourcing
• Custom Manufacturing
• Environmental services
• Excipients / Formulation
• Fine Chemicals
• Finished Dosage
• Generic APIs
• Instruments and Controls
• Intermediates
• Labeling, Coding, Marking and Packaging
• Laboratory Instrumentation
• Logistics – Warehousing and Distribution
• Pharmaceutical Machinery & Equipment
• Plant Engineering and Maintenance
• QA/QC Systems and Services
• Validation and Compliance Support
It’s not too late to Exihibit or Sponsor!
Contact Yvonne e: yvonne.leong@ibcasia.com.sg t: +65-6508 2489
DISCOVER the LATEST
INNOVATIONSattheEXHIBITION:
What’s Included?
*registrationfeesapply;refreshments/cateringaccordingtothesessionsattended.
Lunchiscateredfordelegatesattendingthefulldayon23&/or24Jun
Build Your Agenda
Select your workshops to see which package suits you best:
Sunday 22 June (afternoon) Pre-workshop
A: Quality / Validation
B: Operational Excellence
C: Bio / Sterile / Clean Utilities
Monday 23 June (afternoon)
D: Tech Transfer / Process Validation
E: QBD / PAT
F: Sterile Operations
Tuesday 24 June (full day)
G: Quality / Audit / Regulatory
H: Operational Excellence / Lean Manufacturing
J: Biologics
*WorkshopOnlydoesnotincludeaccesstoOpeningPlenaryon23June
AllotherpackagesincludeaccesstoOpeningPlenaryon23June
Visitor Delegate* Delegate*
(Free) (Non-ISPE (ISPE Member)
Member)
ISPE Exhibition Access ✔ ✔ ✔
ISPE Exhibition Showguide ✔ ✔ ✔
ISPE Student Poster Viewing ✔ ✔ ✔
ISPE Keynote Plenary Session ✔ ✔ ✔
23 Jun (limited seats)
ISPE‘Pharma Nite’Networking ✔ ✔ ✔
23 Jun
Shuttle Bus from Tuas South ✔ ✔ ✔
23-24 Jun (limited seats)
Saving on Registration Fees S$ 50 Up to 20% Up to 55%
Access to Online Networking ✔ ✔
Workshops 22-24 Jun
Delegate Welcome Pack ✔ ✔
Preview & Download Workshop ✔ ✔
Material
Delegate Lunch ✔ ✔
Networking Refreshment Breaks ✔ ✔
MSD Plant Extension Visit 25 Jun ✔ ✔
For more information contact us:
register@ibcasia.com.sg
+65 6508 2401 / +86 21 2326 3680
22 June 23 June 24 June Package Type
Choose 1 Choose 1 Choose 1
from A, B, C from D, E, F from G, H, J
✔ Workshop Only*
✔ Workshop Only*
✔ Workshop Plus
✔ Workshop Plus
✔ Bronze
✔ ✔ Bronze
✔ ✔ Silver
✔ ✔ Silver
✔ ✔ ✔ Gold
www.ispesingapore.org

4. e register@ibcasia.com.sg t +65 6508 2401 / +86 21 2326 3680 f +65 6508 2407
VENUE
ISPE Singapore Conference & Exhibition
Summit 1, Level 3
Suntec Singapore Convention & Exhibition Centre
1 Raffles Boulevard, Suntec City
Singapore 039593
t: +65 6337 2888
www.suntecsingapore.com
HOTEL ACCOMMODATION
Marina Mandarin Singapore
6 Raffles Boulevard, Marina Square
Singapore 039594
t: +65 6845 1188
f: +65 6845 1199
https://resweb.passkey.com/go/ISPESingapore2014
The Future of Pharma Manufacturing is here...
Achieve:
1 Total QUALITY 2 Operational EXCELLENCE 3 CONTINUOUS Improvement
SPONSORS & EXHIBITORS (as @ 10 April)
Site Visit MSD Singapore Plant Extension
Wed 25 June, 0900 – 1200
LIMITED
PLACES!
A new tableting facility extension built as an expansion to
the existing multi product manufacturing facility using a
connection zone for transition of materials, products, peoples
and waste. All production suites are on the ground floor with
a mezzanine area for HVAC and utilities distribution above.
This is a single product family designed facility with four
process trains (one of which is for future), each process train
consists of fluid bed granulation, blending, compression and
coating modules. All these trains are supported by a
centralized dispensing, milling, solution/suspension
preparation area, pack off and washing area.
Depart Arrive
Tuas Biomedical Park Suntec 11.15am 12.15pm
23 & 24 June for exhibits & workshops
Tuas Biomedical Park Suntec 1.30pm 2.30pm
23 June only for exhibits, workshops & Pharma night
Suntec Convention Tuas 4.30pm 5.30pm
23 June only
FREE Shuttle Service:
PRE-REGISTERTODAY to secure your seats!

5. e register@ibcasia.com.sg t +65 6508 2401 / +86 21 2326 3680 f +65 6508 2407
CONFERENCE AND EXHIBITION
Continuous Improvement in the Life Science Industry
REGISTRATION FORM
Early Bird Rate
On or before
April 25, 2014
Special Rate
On or before
May 16, 20 14
Standard rate
after
May 16, 2014
Group Bonus
(3 or more)
Group Bonus
(5 or more)
Registration Fees per person
(please tick)
ISPE Member in Singapore Dollars
■ Workshop Only* S$ 299 S$ 399 S$ 499 S$ 399 S$ 249
■ Workshop Plus S$ 499 S$ 599 S$ 699 S$ 599 S$ 449
■ Bronze Pass S$ 899 S$ 999 S$ 1,099 S$ 999 S$ 849
■ Silver Pass S$ 1,099 S$ 1,199 S$ 1,299 S$ 1,199 S$ 1,049
■ Gold Pass S$ 1,299 S$ 1,399 S$ 1,499 S$ 1,399 S$ 1,249
■ Optional add-ons: Post Event Site Tour (25 June) S$ 85
■ Workshop Only* S$ 699 S$ 799 S$ 899 S$ 799 S$ 649
■ Workshop Plus S$ 899 S$ 999 S$ 1,099 S$ 999 S$ 849
■ Bronze Pass S$ 1,299 S$ 1,399 S$ 1,499 S$ 1,399 S$ 1,249
■ Silver Pass S$ 1,499 S$ 1,599 S$ 1,699 S$ 1,599 S$ 1,449
■ Gold Pass S$ 1,699 S$ 1,799 S$ 1,899 S$ 1,799 S$ 1,649
■ Optional add-ons: Post Event Site Tour (25 June) S$ 85
Non ISPE Member in Singapore Dollars
*Workshop Only does not include access to Opening Plenary on 23 June; all other packages include access
Please type or print clearly. For Group Bookings, add
as required and send together to qualify as a group.
Members and non-members may join together in a
group; the relevant rates will be applied.
To be eligible for ISPE Member rates, please provide the following updated membership details:
ISPE ID # _______________________________________________ Chapter/Affiliate (if not Singapore)________________________________________________
Tick here ■ if you were previously an ISPE Member and wish to renew / join (ISPE will contact you)
DELEGATE 1 • PLEASE PROVIDE YOUR DETAILS TO REGISTER
YOUR NAME____________________________________________________________________________________________________ PRIORITY/VIP CODE ________________________________________________
JOB TITLE _______________________________________________________________________________ DEPARTMENT____________________________________________________________________________
COMPANY_______________________________________________________________________________________________________________________________________________________________________
BUSINESS ADDRESS _______________________________________________________________________________________________________________________________________________________________
CITY____________________________________________________________________________________POSTAL CODE__________________________COUNTRY _________________________________________
BUSINESS TEL____________________________________________________________________________EMAIL__________________________________________________________________________________
EMERGENCY PHONE (CELL PHONE FOR LAST MINUTE MEETING UPDATES) __________________________________________________________________________________________________________________
Please select the Workshops which you plan to attend:
Wed 25 Jun: Post event (morning)
■ Site Visit to MSD Plant Extension
Sun 22 Jun: Pre-event (afternoon)
(Select 1 from):
■ A: Quality / Validation OR
■ B: Operational Excellence OR
■ C: Bio / Sterile / Clean Utilities
Mon 23 Jun (afternoon)
(Select 1 from):
■ D: Tech Transfer / Process Validation OR
■ E: QBD / PAT OR
■ F: Sterile Operations
Tue 24 Jun (full day)
(Select one workshop from):
■ G: Quality / Audit / Regulatory OR
■ H: Operational Excellence / Lean Manufacturing OR
■ J: Biologics

6. e register@ibcasia.com.sg t +65 6508 2401 / +86 21 2326 3680 f +65 6508 2407
CONFERENCE AND EXHIBITION
Continuous Improvement in the Life Science Industry
REGISTRATION FORM
Please type or print clearly. For Group Bookings, add
as required and send together to qualify as a group.
Members and non-members may join together in a
group; the relevant rates will be applied.
DELEGATE 2
To be eligible for ISPE Member rates, please provide the following updated membership details:
ISPE ID # _____________________________________ Chapter/Affiliate (if not Singapore)______________________________________ ■ I wish to renew/join.
Name________________________________________________________________ Job Title_______________________________________________________
Email _________________________________________________________________Tel____________________________________________________________
Emergency phone (Cell Phone for last minute meeting updates) _______________________________________________________________________________
Please select the Workshops which you plan to attend:
Wed 25 Jun: Post event (morning) ■ Site Visit to MSD Plant Extension
Sun 22 Jun: Pre-event (afternoon)
(Select 1 from):
■ A: Quality / Validation OR
■ B: Operational Excellence OR
■ C: Bio / Sterile / Clean Utilities
Mon 23 Jun (afternoon)
(Select 1 from):
■ D: Tech Transfer / Process Validation OR
■ E: QBD / PAT OR
■ F: Sterile Operations
Tue 24 Jun (full day)
(Select one workshop from):
■ G: Quality / Audit / Regulatory OR
■ H: Operational Excellence / Lean Manufacturing OR
■ J: Biologics
DELEGATE 3
To be eligible for ISPE Member rates, please provide the following updated membership details:
ISPE ID # _____________________________________ Chapter/Affiliate (if not Singapore)______________________________________ ■ I wish to renew/join.
Name________________________________________________________________ Job Title_______________________________________________________
Email _________________________________________________________________Tel____________________________________________________________
Emergency phone (Cell Phone for last minute meeting updates) _______________________________________________________________________________
Please select the Workshops which you plan to attend:
Wed 25 Jun: Post event (morning) ■ Site Visit to MSD Plant Extension
Sun 22 Jun: Pre-event (afternoon)
(Select 1 from):
■ A: Quality / Validation OR
■ B: Operational Excellence OR
■ C: Bio / Sterile / Clean Utilities
Mon 23 Jun (afternoon)
(Select 1 from):
■ D: Tech Transfer / Process Validation OR
■ E: QBD / PAT OR
■ F: Sterile Operations
Tue 24 Jun (full day)
(Select one workshop from):
■ G: Quality / Audit / Regulatory OR
■ H: Operational Excellence / Lean Manufacturing OR
■ J: Biologics
DELEGATE 4
To be eligible for ISPE Member rates, please provide the following updated membership details:
ISPE ID # _____________________________________ Chapter/Affiliate (if not Singapore)______________________________________ ■ I wish to renew/join.
Name________________________________________________________________ Job Title_______________________________________________________
Email _________________________________________________________________Tel____________________________________________________________
Emergency phone (Cell Phone for last minute meeting updates) _______________________________________________________________________________
Please select the Workshops which you plan to attend:
Wed 25 Jun: Post event (morning) ■ Site Visit to MSD Plant Extension
Sun 22 Jun: Pre-event (afternoon)
(Select 1 from):
■ A: Quality / Validation OR
■ B: Operational Excellence OR
■ C: Bio / Sterile / Clean Utilities
Mon 23 Jun (afternoon)
(Select 1 from):
■ D: Tech Transfer / Process Validation OR
■ E: QBD / PAT OR
■ F: Sterile Operations
Tue 24 Jun (full day)
(Select one workshop from):
■ G: Quality / Audit / Regulatory OR
■ H: Operational Excellence / Lean Manufacturing OR
■ J: Biologics
DELEGATE 5
To be eligible for ISPE Member rates, please provide the following updated membership details:
ISPE ID # _____________________________________ Chapter/Affiliate (if not Singapore)______________________________________ ■ I wish to renew/join.
Name________________________________________________________________ Job Title_______________________________________________________
Email _________________________________________________________________Tel____________________________________________________________
Emergency phone (Cell Phone for last minute meeting updates) _______________________________________________________________________________
Please select the Workshops which you plan to attend:
Wed 25 Jun: Post event (morning) ■ Site Visit to MSD Plant Extension
Sun 22 Jun: Pre-event (afternoon)
(Select 1 from):
■ A: Quality / Validation OR
■ B: Operational Excellence OR
■ C: Bio / Sterile / Clean Utilities
Mon 23 Jun (afternoon)
(Select 1 from):
■ D: Tech Transfer / Process Validation OR
■ E: QBD / PAT OR
■ F: Sterile Operations
Tue 24 Jun (full day)
(Select one workshop from):
■ G: Quality / Audit / Regulatory OR
■ H: Operational Excellence / Lean Manufacturing OR
■ J: Biologics