ISPE Singapore 2014

22 - 24 June 2014 • Suntec Singapore

CONFERENCE AND EXHIBITIONContinuous Improvement in the Life Science Industry

NEW! ISPE Singapore’s dedicated Exhibitionintegrated with the Conference

Take your pick from Keynote plenary sessions,technical workshops and tracks

Learn from international and regionalexperiences, process and technologyinnovations

Gather latest techniques and solutions fromtechnology providers and experts

Meet your peers and expand your networkof manufacturing professionals

Continuous Improvement in the LifeScience Industry

ISPE Singapore Conference is YOUR industryevent. Developed by your industry peers,

the programme and educational platformaddresses the region’s pressing

pharmaceutical manufacturing issues,relevant to both multinational

and regional manufacturers.

MAXIMISE YOUR TIME @ISPE SINGAPORE90% 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

PLUSISPE Exhibition of Latest technology & innovations

www.ispesingapore.org

YOUR industry’sannual meeting for

pharma &biomanufacturing

WELCOME!The ‘New-look’ ISPE

Singapore

Co-organised by

Scan this QR Code withyour smartphone toview online and register

Operational Excellence & Lean ManufacturingThrough Single-Use TechnologiesMinh Tran, Technology Specialist Group Manager (AsiaPacific), Single Use Processing, Merck Millipore

ISPE Singapore Conference 2014Continuous 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 WorkshopJohn Hyde, Chairman & Founder, Hyde Engineering+ Consulting, USA

Value Stream Mapping in an Engineering ContextJohn Guerin, General Manager, Zenith Technologies,Singapore & Bryan McSwiney, Global ChiefTechnology Officer, Zenith Technologies, Ireland

Cross Industry Expertise in Filtration, RO, PurifiedWater and Water for InjectionMike Gaunt, Technology Manager – PharmaceuticalProcess Water, Veolia Water Solutions &Technologies, UK

MONDAY • 23 JUNE

PLENARY KEYNOTE SESSIONS

0900 – 0915 Welcome AddressPierre Winnepenninckx, President, ISPE Singapore Affiliate

0915 – 1000 Update on “Office of Pharmaceutical Quality,” What’s New in CDER and How it Affects Your ProcessJanet Woodcock, Director, FDA/DHHS/Accounting Operations, USA, Video Presentation

1000 – 1045 Developments in Asia Pacific – GMP Update and OutlookBob 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 AsiaJagmohan 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, PwCChristopher Langwallner, CEO, NamzChris McNamara, Executive Director, MERCK

1245 – 1400 Conference Networking Lunch

Workshop D: Tech Transfer / Process Validation Workshop E: QBD / PAT Workshop F: Sterile Operations

1400 – 1445Analytical Validation in the Context of aTechnology TransferDr Ludwig Huber, Director and Editor,Labcompliance, Germany

Mitigating Risk and Implementing QbD with RealTime Process Monitoring of Pharma, Bio-PharmaProcessesSaby Goswami, Asia Sales Manager, Umetrics

Retrofitting/Upgrading Containment Equipmentto Eliminate PPEXL Lin, Market Development Director / General Manager– Pharma/Containment – Singapore, Esco Group

1445 – 1530

Scale Up & Tech Transfer for Single UseTechnologiesSuyamburam Sathasivam, Head of TechnicalOperations, Stelis Biopharma, Malaysia

Learnings for Quality-by-Design (QbD) from a TotalQuality Management (TQM) PerspectiveDr Chew Wee, Research Scientist, Institute of Chemical& Engineering Sciences, A*STAR, Singapore

Methods and Application Examples of RoomPressure Control in CleanroomsMitsuru Saito, Okaya Seiritsu EngineeringCo Ltd, Japan

1530 – 1615 Afternoon Networking Refreshments in Exhibit Hall

1615 – 1700

The Use of Integrated Mass Spectrometer as PATTool – In-line Process Monitoring and Detection ofSilicon Oil LeakagesUwe Meissner, Business Development and ApplicationsManager, MKS Instruments Analytical SolutionGroup, Germany

Single Use Technology: A Customer ViewpointJagmohan Satischandra, VP, Engineering & Projects,Stelis Biopharma, Malaysia

1700 – 1745

Retroactive Design Space CharacterizationThrough CPP/CQA Relationships and ControlStrategy (Considerations for Transferring LegacyProducts)John Wass, Project Manager, Commissioning AgentsInternational, Inc., USA

QbD – Overview on Principle and Regulatory andIndustry ActivitiesDr 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 / RegulatoryWorkshop H: Operational Excellence / LeanManufacturing Workshop J: Biologics

0900 – 0945

Conducting A Remote AuditDanny Tan, Global GMP Compliance Audit Manager,F. Hoffmann-La Roche, Singapore

Designing – Lean Manufacturing Facility:Manufacturers' PerspectiveSujit Kinge, Associate Director (Operations) &Srinivas Yedavalli, Project Quality Lead,Merck Sharp & Dohme GmbH Ltd, Singapore

The Application of Good Project ManagementSkills to the C&Q Phase of ProjectsPeter Roche, Projects Manager, Singapore & DeclanO’Shea, Senior Commissioning & Qualification Engineer,PM Group

0945 – 1030

Cleanroom HVAC Turndown – Experimental Dataand Regulatory ChallengesAshley Isbel, Lead Consultant, PharmOut, Australia

Paperless Manufacturing, a Lean Opportunity forBatch RecordingDavid 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 & itsImplications for Manufacturers in Asia PacificDr Vee Revithim, Head of External Relations Europe,F. Hoffmann-La Roche, Switzerland

Dispensing and Blending of High Potency ActivePharmaceutical Ingredients (HPAPIs) for TabletPress FeedingFrédéric Dietrich, Managing Director,Dietrich Engineering Consultants, Switzerland

High Containment Powder Handling –Considerations for Reducing Risk and IncreasingPerformanceMichael Avraam, Global Product Manager,ChargePoint Technology Ltd, UK

1230 – 1330 Workshops Lunch

Latest Trends in Data Integrity ObservationsDuring Regulatory Inspection: A Multi Regionaland International PerspectiveAshley Hankinson, Managing Director, GlobalCompliance International, Singapore

1145 – 1230

1330 – 1500

TPM Implementation WorkshopSamuel Ong, TMP Program Manager, NovartisSingapore

1500 – 1530 End of Workshops followed by Afternoon Networking Refreshments in Exhibit Hall

Tank Design for Pharma – What You Need to KnowPierre Winnepenninckx, Managing Director,No deviation Pte Ltd / President, ISPE SingaporeAffiliate

Handling Regulatory GMP InspectionsBob Tribe, Former Chairman of PIC/S & Asia PacificRegulatory Affairs Advisor, ISPE


ISPE Singapore is for YOU!Vice Presidents, Directors, General Managers, PlantManagers, Heads of Departments, Managers, Group / Team/ Project Leaders, Senior Scientists, Engineers, Developmentand Technical / Application, Specialists, Site and ProjectDirectors, Quality Control / Quality Assurance, Professorsinvolved 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: [email protected] t: +65-6508 2489

DISCOVER the LATESTINNOVATIONS at the EXHIBITION:

What’s Included?

*registration fees apply; refreshments/catering according to the sessions attended.

Lunch is catered for delegates attending the full day on 23 &/or 24 Jun

Build Your AgendaSelect your workshops to see which package suits you best:

Sunday 22 June (afternoon) Pre-workshopA: Quality / ValidationB: Operational ExcellenceC: Bio / Sterile / Clean Utilities

Monday 23 June (afternoon)D: Tech Transfer / Process ValidationE: QBD / PATF: Sterile Operations

Tuesday 24 June (full day)G: Quality / Audit / RegulatoryH: Operational Excellence / Lean ManufacturingJ: Biologics

*Workshop Only does not include access to Opening Plenary on 23 June

All other packages include access to Opening Plenary on 23 June

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:[email protected]

+65 6508 2401 / +86 21 2326 3680

22 June 23 June 24 June Package Type

Choose 1 Choose 1 Choose 1from A, B, C from D, E, F from G, H, J

✔ Workshop Only*

✔ Workshop Only*

✔ Workshop Plus

✔ Workshop Plus

✔ Bronze

✔ ✔ Bronze

✔ ✔ Silver

✔ ✔ Silver

✔ ✔ ✔ Gold


e [email protected] t +65 6508 2401 / +86 21 2326 3680 f +65 6508 2407

VENUE

ISPE Singapore Conference & Exhibition

Summit 1, Level 3Suntec Singapore Convention & Exhibition Centre

1 Raffles Boulevard, Suntec CitySingapore 039593t: +65 6337 2888www.suntecsingapore.com

HOTEL ACCOMMODATION

Marina Mandarin Singapore

6 Raffles Boulevard, Marina SquareSingapore 039594t: +65 6845 1188f: +65 6845 1199https://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 ExtensionWed 25 June, 0900 – 1200

LIMITEDPLACES!

A new tableting facility extension built as an expansion tothe existing multi product manufacturing facility using aconnection zone for transition of materials, products, peoplesand waste. All production suites are on the ground floor witha mezzanine area for HVAC and utilities distribution above.This is a single product family designed facility with fourprocess trains (one of which is for future), each process trainconsists of fluid bed granulation, blending, compression andcoating modules. All these trains are supported by acentralized dispensing, milling, solution/suspensionpreparation area, pack off and washing area.

Depart Arrive

Tuas Biomedical Park Suntec 11.15am 12.15pm23 & 24 June for exhibits & workshopsTuas Biomedical Park Suntec 1.30pm 2.30pm23 June only for exhibits, workshops & Pharma nightSuntec Convention Tuas 4.30pm 5.30pm23 June only

FREE Shuttle Service:PRE-REGISTER TODAY to secure your seats!



REGISTRATION FORM

Early Bird RateOn or before

April 25, 2014

Special RateOn or before

May 16, 20 14

Standard rateafter

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, addas required and send together to qualify as a group.

Members and non-members may join together in agroup; 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



REGISTRATION FORMPlease type or print clearly. For Group Bookings, addas required and send together to qualify as a group.

Members and non-members may join together in agroup; the relevant rates will be applied.

DELEGATE 2


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) _______________________________________________________________________________


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



Name________________________________________________________________ Job Title_______________________________________________________

Email _________________________________________________________________Tel____________________________________________________________







DELEGATE 4



Name________________________________________________________________ Job Title_______________________________________________________

Email _________________________________________________________________Tel____________________________________________________________







DELEGATE 5



Name________________________________________________________________ Job Title_______________________________________________________

Email _________________________________________________________________Tel____________________________________________________________





