ISPE Singapore 2014

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We’re pleased to announce that the Conference and Workshop programme for ISPE Singapore is ready to view on www.ispesingapore.org

FINAL BROCHURE NOW AVAILABLE FOR DOWNLOAD HERE!

This year, you’ll find:
• 90% NEW & 50% MORE Speakers than in 2013
• Over 34 presenters sharing their case studies and experience
• Choose from 36 hours of Learning, 6 hours of Networking Across the Plenary Conference & 9 practical workshops
• The latest solutions at the ISPE Singapore Exhibition on 23-24 June
• And don’t forget to sign up for the Site Visit to MSD Singapore Plant Extension!
Build your own agenda from 3 concurrent sessions:

Sunday 22 June (1.30-5.30pm):
A: Quality / Validation
B: Operational Excellence
C: Bio / Sterile / Clean Utilities
Monday 23 June (2.00-5.45pm):
D: Tech Transfer / Process Validation
E: QBD / PAT
F: Sterile Operations
Tuesday 23 June (9.00-3.30pm):
G: Quality / Audit / Regulatory
H: Operational Excellence / Lean Manufacturing
J: Biologics

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ISPE Singapore 2014

  1. 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. 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. 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. 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. 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. 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

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