Programme

6 June 2010, Sunday

Workshop 1

Workshop 2

Effective Cleaning Validation Programme for Biologics Facility

Leader: David Vincent, CEO, Validation Technologies Inc.

Leader: Gordon Farquharson, Managing Director, Critical Systems

*Programme subject to change

Welcome Message - Stephen Slater, President, ISPE Singapore Affiliate
Opening Address - Robert Best, President/CEO, ISPE
FDA Regulatory Keynote – Edwin Rivera-Martinez, Head of International Compliance Branch, CDER, FDA ~ “Effective Enforcement Benefits to Public Health” or FDA speaker from India or China regional office
Dr. Kowid Ho, EMEA
“Effective Regulation through International Cooperation”, Michel Lok, Head of Office, Office of Manufacturing Quality, Therapeutic Goods Administration
Industry Overview Keynote - Jan Willem Eleveld, Vice President Consulting & Services, APAC, IMS Health

REGULATORY	API	AUTOMATION
FDA US or India/China regional office Dr. Kowid Ho, EMEA “Aseptic and Sterile Manufacture - Regulatory Challenges”, Andrew Lattimore, Senior Auditor, Office of Manufacturing Quality, Therapeutic Goods Administration "Towards A Quality Assurance System for Drug Regulatory Authorities", Sia Chong Hock, Division Director, Manufacturing & Quality Audit Division, Health Sciences Authority	“Design considerations for Optimal Cleanability in API Equipment”, Dr. Bassel Iskandarani, Director of Pharmaceutical Technology, MSD Singapore "Application of NIR as real time monitoring tool in API manufacturing”, Mohammad Nazrin Abdul Samat, Senior Chemical Engineer, Technical Development, GlaxoSmithKline GSK or Merck	“The role of Automation in Global Pharmaceutical anti-counterfeiting”, Bryan McSwiney, Director, Asia & Middle East, Zenith Technologies "Implementation of an Electronic Batch Record system in a Biologics Production Facility”, Mike Pelletier, Associate Director of Engineering, Lonza Biologics Singapore “PAT, the enabler for continuous manufacturing processes - An innovative way of developing and producing drugs”, Bart Moors, Senior Business and Project Manager Pharmaceutical Industry SEA, Siemens AG

*Programme subject to change

Concurrent	Breakout Tracks	Full Day Track
Biologics	Validation	Innovation
“The Advantages of Leveraging Manufacturing Plant Designs Globally”, John Machulski, Senior Project Director, Lonza Biologics Singapore “Multi-Product Strategies in a Biologics Facility”, Dan Hagewiesche, Director of CHO Production, Roche Singapore Technical Operations “ Quality Management in Biologics Manufacturing”, Dr. Praveen Kumar, Director, Quality Assurance & Regulatory Affairs, Alpha Biologics Sdn Bhd	ISPE Article of the Year 2009 “The FDA’s Draft Process Validation Guidance – A Perspective from Industry”, Dr. Alice Redmond, CQ Technical Director, PM Group “Current Industry and Regulatory Requirements for Biological Process Validation”, David Vincent, CEO, Validation Technologies Inc. “Validation Strategies for a Fast track API Facility”, Todd Mabe, Principal Technical Manager, Validations, Roche Singapore Technical Operations	ISPE Facility of the Year Award 2009 (Sustainability) – Centocor Case Study, Con Leddy “Achieving effective containment facilities”, Gordon Farquharson, Managing Director, Critical Systems Carla Boragno, Roche Singapore Technical Operations

Concurrent	Breakout Tracks	Full Day Track
Secondary Pharma Mfg	Supply Chain	Innovation
" The basics of Aseptic Processing, and trends in Aseptic techniques", Martin R. Dyxenbourg, Senior Production Manager, Insulin Filling Plant, Tianjin, China, Novo Nordisk A/S “Use of RABS in Sterile Manufacturing”, Anuj Sharda, Production Manager, Biotechnology Plant, MSD Singapore “Automation for Aseptic Manufacturing”, Gaurav Mehta, Principal Project Automation Engineer, Alcon Singapore Manufacturing	“The changing focus of Regulators” – Senior Staff of TGA “Ensuring Quality in the Supply Chain”, Tony Uhe, Senior Director Quality Operations, External Manufacturing, Asia Pacific, GPSG, Johnson & Johnson “Proactive Strategies for Managing Your Distribution Network”, Darren Freestone, Senior Consultant, SeerPharma	“Containment – Is an isolator just an expensive box?” , Simon White, Sales Director, Pharmaceutical Services Corporation Ltd “Green Pharmaceutical Manufacturing”, Dr. Paul Sharratt, Programme Manager, Process Science & Modelling Institute, Institute of Chemical & Engineering Sciences, ASTAR ISPE Facility of the Year Award 2010 for Project Execution (Case Study of Genentech Singapore facility)*

*Programme subject to change

9 June 2010, Wednesday

09:00 AM - 12:00 PM | Facility Visits

Facility visits are open to conference delegates who register for a minimum of a 2 Day Conference Pass, for one facility selection per registration. Each facility visit will have limited seats allocated, and each seat will be allocated on a space available basis.