Plant Tours: 16 September 2009

Timetable

Plenary Workshop Forum Compliance Operational Excellence Facilities, Process & Project Management Break Function Poster

Sunday, 13 September 2009
13:00	01GAMP 5 Workshop: David Selby, Selby Hope International Bayside 201	02Applying ICH and ASTM E2500 in Manufacturing - What is critical? RiskMaPP - Determining Operator and Product Risks "Bruce Davis, Global Consulting" Bayside 202
17:00
18:00	33Welcoming Drinks & Networking
19:30

Monday, 14 September 2009
08:30	03Plenary Session Bayside 204 Opening & Welcome Roger Dowding, Merck Sharp & Dohme, Australia ISPE Australasia and ISPE International Update Robert Best, ISPE, Australia Prevention of cervical cancer through vaccination - a case study in translation of basic research Ian Frazer, The University of Queensland, Australia The implications of "Science and risk based" on business and manufacturing. And where does ISPE's PQLI programme fit in to this? Bruce Davis, Global Consulting, Australia
10:00	34Morning Tea Bayside Terrace
10:30	04Plenary Session 2 Bayside 204 Ensuring effective and efficient GMP compliance in challenging times Michel Lok, Office of Manufacturing Quality, TGA, Australia PIC/S : a key partner in the worlwide globalisation of pharmaceutical products Jacques Morenas, PIC/S, France Risk Management: Religion or Remedy? David Selby, Selby Hope International Global Trends and Local Issues - Pharma Industry Challenges in 2009 Chris Proctor, IMS Health
12:50	35Lunch Bayside Terrace
14:20	10Facilities, Process And Project Management Bayside 204 14:00 - 14:20 Introduction Process understanding tools: the major pitfalls of SPC Brad Swarbrick, CAMO, Australia	11Operational Excellence Bayside 201 Developing a sustainable manufacturing plant servicing global markets Justin Daly, HOSPIRA, Australia	12Compliance Bayside 202 A changing world for GMP : a regulator point of view Jacques Morenas, PIC/S, France
15:20	36Afternoon Tea Bayside Terrace
15:40	13Cleanroom Design Forum Bayside 204 'Members of the Facility Design Forum: Darren Green (Zektin) Michael Mason (APC) Doug Crawford (S2F) Michael Cashell (Moore & Cashell) Ross Chester (Polynovo)	14Operational Excellence Bayside 201 17:20 - 17:30 Session Wrap Up Can lean manufacturing save Australasia Pharma? Bernard Kornfeld, Baxter Healthcare How Lean is changing traditional supply & manufacturing practices at AstraZeneca Australia Paul Ives, AstraZeneca	15Compliance Bayside 202 17:20 - 17:30 Session Wrap Up Balancing regulatory compliance and business imperatives Trevor Schoerie, PharmOut Pty Ltd, Australia The 3C’s: how to drive a product through R&D into the global regulatory environment from Australia Adrian Oates, Universal Biosensors
17:30
19:00	37Conference Dinner Cruise & Entertainment
23:00

Tuesday, 15 September 2009
08:30	16Facilities, Process And Project Management Bayside 203 08:30 - 08:40 Introduction PQLI Illustrative Example - ISPE's Product Quality Lifecycle Initiative Bruce Davis, Global Consulting, Australia Current guidelines for environmental monitoring in pharmaceutical cleanrooms Jason Kelly, Kenelec	17Operational Excellence Bayside 201 08:30 - 08:40 Introduction Continuous Improvement at CSL - Genesis to Revelation! Bill Cracknall, CSL Lifecycle Brand Management Adam Ransom, SCHAWK, Australia	18Compliance Bayside 202 08:30 - 08:40 Introduction Good Distribution Practices Mark Hammond, Merck Sharp & Dohme Changes to manufacturing standards, implementation of risk management and other TGA program updates Noel Fraser, TGA
10:20	38Morning Tea Bayside Terrace
10:50	19Project Case Studies Bayside 203 Moderator – Andrew Watson, Wilkore Ross Giblett, Mike Reed – Hooker Cockram Pharmaxis and ANSTO Projects Simon Wrangham - Logistics Bureau Liquids Manufacturing Facility Paul Malouf - Biological Therapies Sterile Manufacturing Facility	20Operational Excellence Bayside 201 Productivity improvements in support areas of Manufacturing Ivy Leung, GSK Boronia, Australia Productivity through Understanding your people Sean Thomas, TIMA Consulting	21Compliance Bayside 202 Process Validation. The FDA's Draft Guideline David Selby, Selby Hope International Balancing regulatory compliance and business imperatives Trevor Schoerie, PharmOut Pty Ltd, Australia
12:40	22CPIP Workshop: Steve Williams, CPIP Chair Bayside 202	39Lunch Bayside Terrace
13:50	24Facilities, Process and Project Management Bayside 203 13:50 - 14:00 Introduction Alternative Project Delivery Strategies John Montalto, Australia Project Finance Helen Wray, Watershed Corporate, Australia	25Operational Excellence Bayside 201 13:50 - 14:00 Introduction Executive Lean Leadership - Learning from the Toyota way Gary Stewart, AISIN	26Compliance Bayside 202 13:50 - 14:00 Introduction GMP - Looking ahead, making the grade, staying there – a Medsafe view Derek Fitzgerald, Medsafe, New Zealand
14:50	32Afternoon Tea Bayside Terrace
15:10	27Facilities, Process And Project Management Bayside 203 Biomanufacturing and single use technologies : driving towards integrated solutions Marty Siwak, Millipore Practical Project Management for Life Science Projects Kylie Brailsford, Synertec, Australia	28Leadership Forum Bayside 201 Moderator - Bob Tribe Members of the Leadership Forum: Tony Broughton, AstraZeneca Rob Douglas, ResMed Noel Fraser, TGA Peter Hartley, Sphere Dig Howitt, Cochlear Ian Finlay, SIGMA Pharmaceuticals Graham Garside, i-Nova Justin Daly, Hospira Derek Fitzgerald, Medsafe Kylie Sproston, BTG Australasia	29Compliance Bayside 202 IT Infrastructure Qualification - How much is enough? Jon Reich, Synertec, Australia Introducing a Validated Data Audit Trail of Historic Databased Changes John Nesbitt, Wayahead Systems, Australia Carbon Pollution Measurement and Control Andrew Gunst, Pharmaceutical Solutions
17:00

Wednesday, 16 September 2009
09:00	30Plant Tours Astra Zeneca Pfizer I-NOVA Resmed GSK Sphere MSD
12:00