Program / Workshops

Leadership Forum Speakers

Keynote Sessions

Monday 14th September 2009

Speaker: Bruce Davis

The implications of "Science and risk based" on business and manufacturing. And where does ISPE's PQLI programme fit in to this?

Synopsis:
The Keynote will consider the implications of the term "science and risk based", and its implications on business, manufacturing and capital effectiveness. It will discuss whether it enables our industry to make better products and what contributions engineers can make to this.

It will also give background to ISPE's Product Quality Lifecycle Implementation and explain the how this new initiative fits internationally. It will explain what topics are involved, what the outputs will be and how it links to regulatory matters.

Speaker: Michel Lok

Ensuring Effective and Efficient GMP Compliance in Challenging Times

Synopsis:
Ensuring effective and efficient GMP compliance in challenging times. This Keynote will examine the conflicting demands on regulators to meet the expectations of government and the community for high standards of quality and safety in medicinal products and devices whilst minimising unnecessary regulatory burdens on industry.

The presentation will outline approaches being developed by the TGA's Office of Manufacturing Quality to address specific manufacturing risks and build compliance incentives into its processes, and will show how international partnerships are being used to achieve regulatory objectives.

Speaker: David Selby

Risk Management: Religion or Remedy?

Synopsis:
Competition and cost containment is driving the pharmaceutical industry as never before. Every company is focusing on cost reduction but patient health cannot be compromised.
Risk Management is promoted as the tool to focus the efforts and activities of the pharmaceutical development and manufacturing industry to where it adds most value whilst at the same time protecting the patient.

This presentation, will offer an overview of risk management as it is currently practiced and use numerous examples to illustrate how it can be applied to both the advantage and the disadvantage of the patient and the company.

The examples will come mostly from the GMP world as the use of risk management in Quality by Design will be covered by Mr. Bruce Davis in another presentation.

Robert P. Best

Robert P. Best

President/Chief Executive Officer, ISPE

Robert P. (Bob) Best is the President and CEO of ISPE, the International Society for Pharmaceutical Engineering, the Society of choice for 25,000 pharmaceutical manufacturing professionals in 90 countries around the globe.

Best joined ISPE as Executive Director in January 1985 and was named President in November 1998. Under Best's 20-plus years of leadership and guidance, ISPE has grown exponentially to become a global Society with more than 40 Affiliates and Chapters worldwide. The staff has grown from four employees in 1985 to more than 65 in offices in Tampa, Florida, Brussels, Belgium, and Singapore.

Under Best's leadership, ISPE was awarded the U.S. Food and Drug Administration (FDA) Commissioner's Special Citation in 1997 "in appreciation of outstanding cooperation with the Food and Drug Administration in providing vital support to the industry through educational and special projects, nationally and internationally."

In 1997, ISPE was also honored with Vice President Al Gore's Hammer Award, which was presented for its work on the efficient implementation of Scale-Up and Post-Approval Changes (SUPAC) guidance for products in immediate release - solid dosage form.

Again in 2005, ISPE received a Commissioner's Special Citation from the FDA from Dr. Janet Woodcock, in recognition of ISPE's "outstanding commitment and many years of continued support of crucial initiatives."

Initiatives include publishing a new science-based, peer-reviewed journal: the Journal of Pharmaceutical Innovation, launched September 2006. The FDA also called upon ISPE to develop a training program to be utilized by both Industry and Regulators; and establish a competency-based global industry certification program, the Certified Pharmaceutical Industry Professional (CPIPSM) that sets a standard for Pharmaceutical Manufacturing Science and Technology competency. The CPIP was launched in 2006 and is an international certification program for pharmaceutical manufacturing professionals.

Before joining ISPE, Best was Director of Public Relations and Promotions for the Tampa Bay Buccaneers U.S. National Football League team. He earned his Bachelor of Arts and Master degrees in Communications/Marketing from Notre Dame University, and was assistant sports information director for the university from 1973-1978. Prior to this, he was the Assistant Public Relations Director of the Pittsburgh Pirates U.S. Major League Baseball team, and a sports reporter for the Cincinnati Post and Times Star newspapers.

Bruce Davis

Bruce Davis

Bruce Davis is a professional engineer and has many years of experience in the pharmaceutical industry. He has been involved in pharmaceutical engineering projects for API, secondary manufacturing and packaging for AstraZeneca. He led engineering teams in these areas, from early business thinking to concept development to project delivery and managed the global capital programme.

He has a wide international knowledge and has carried out business/engineering studies for new plants and new developments internationally.

He has led cross-functional Quality by Design (QbD)workshops.
For ISPE, he was the 2008 Chairman.

He a major contributor and leader of ISPE's Product Quality Lifecycle Implementation (PQLI) initiative, he also co-leads the Control Strategy team, which has brought new thinking into delivering Control Strategies to meet ICHQ8/Q9/Q10 requirements. He has also had involvement in many other ISPE matters, including chairing the Sterile Baseline® Guide task team.
He is secretary to ASTM E55.03 Committee on General Pharmaceutical Standards.
From beginning of 2009, he will running his own consultancy in Engineering for QbD.

Professor Ian Frazer

Professor Ian Frazer

Ian Frazer is director of the Diamantina Institute of Cancer Immunology and Metabolic Medicine, a research institute of the University of Queensland at the Princess Alexandra Hospital in Brisbane. He was trained as a renal physician and clinical immunologist in Edinburgh, Scotland before emigrating in 1981 to Melbourne, Australia to continue his clinical training and to pursue studies in viral immunology and autoimmunity at the Walter and Eliza Hall institute of Medical Research with Prof Ian Mackay. In 1985 he moved to Brisbane to take up a teaching post with the University of Queensland, and he now holds a personal chair as head of the Diamantina Institute. This institute employs over 200 researchers and trains over 30 postgraduate students. Dr Frazer's current research interests include immunoregulation and immunotherapeutic vaccines, for which he holds research funding from several Australian and US funding bodies. Dr Frazer teaches immunology to undergraduate and graduate students of the University. He is president of the Cancer Council Australia. He has sat on various committees of the National Health and Medical Research Council of Australia continuously over the last 15 years. He advises the WHO on papillomavirus vaccines. He was chosen as the 2006 Queenslander of the Year and the 2006 Australian of the Year.

Michel Lok

Michel Lok

Michel became Head of the TGA's Office of Manufacturing Quality in September 2008 and is responsible for the licensing of Australian therapeutics manufacturers and the assessment of overseas manufacturer's compliance with standards of Good Manufacturing Practice.

Michel previously spent four years as the TGA's Chief Financial Officer, implementing new corporate systems and procedures and aligning budgets to match its regulatory strategies and priorities. He has held a number of Senior Executive positions within the Health and Ageing and the Families and Community Services Portfolio's, including oversight of the nation's billion dollar investment in medical research with the National Health and Medical Research Council; addressing health infrastructure shortages in Indigenous communities; and implementing compliance frameworks across a major government department.

Michel holds a masters degree in Financial Management and is a Certified Practising Accountant.

Jacques Morenas

Jacques Morenas

Assistant Director

French Agency for the Safety of Health Products (AFSSAPS) Chairman, PIC/S Jacques Morénas is civil servant as « pharmacien général de santé publique » and belongs to the pharmacist-inspector profession. He is graduated as a pharmacist from the faculty of pharmacy (1977) [University of Clermont-Ferrand (France)]. He received his pharmacist inspector degree from the National School for Public Health (1980) [Rennes (France)] He had different positions in the French health administration in the Ministry of Health and in the regional inspectorate of Paris.

He joined the French Drug Agency in 1993 and is actually assistant director of the Inspection and Companies department in the French Health Products Safety Agency (AFSSAPS), in Saint Denis (France). He is in charge of international affairs (in the field of good manufacturing practice), quality assurance (for the Inspection and Companies department), including training (for the inspectors of the French Agency). At the European level, he is the AFSSAPS's representative to the GMDP IWG of European Medicines Agency (EMEA-Londres). At the International level, he is the chairman of the Pharmaceutical Inspection Cooperation Scheme (PIC/S). He is also involved, as EU expert, in ICH discussions concerning implementation of Q8, Q9 and Q10 documents and he is participating to the WHO program on pre-qualification of vaccines (assessment of National Regulatory Authorities).

David Selby

David Selby

David Selby, BSc., PhD, MCQI., has spent all his working life in the pharmaceutical industry, mostly in roles requiring knowledge of GMP and the regulatory environment.

After some years in research and development at Glaxo, he moved to international GMP compliance auditing, before becoming responsible for the manufacture of tablets, and then antibiotics at the Glaxo site in Co. Durham, UK. Subsequently he occupied the role of Site Quality Assurance Manager there and latterly, he was the Site Manager.

In 1998 he established his own consultancy, Selby Hope International, Ltd., specialising in the compliance of computerised systems and automated equipment used in pharmaceutical manufacturing. His clients include many of the major pharmaceutical companies, key engineering suppliers and a number of the regulatory agencies.

He also acts as a technical adviser to the Boards of Directors of a number of companies.

He is eligible to act as a Qualified Person under EU Law.

He served for a full term of 9 years as a Director on the International Board of ISPE and in 2003-4 was elected Chairman of the International Society of Pharmaceutical Engineering (ISPE,) the first non-American to be so honoured. He continues to be involved in the many ISPE initiatives and the orgainsation of many courses. He is a founder member and Chairman of the GAMP Forum and is currently the Chairman of ISPE's Product Quality Lifecycle Implementation (PQLI) Executive Committee, responsible for writing guidance to support the priniciples of Quality by Design.

Session Speaker Synopsis

Speaker: Kylie Brailsford

Practical Project Management for Life Science Projects

Synopsis:
Project Managers face a unique set of challenges when managing Life Science projects. Projects in other industries can be complex enough with the various technical, cost and time hurdles to jump, but add to that the intense regulatory impact of a Life Science project and you have some
serious pole vaulting to do!
Project Managers in this environment need to be on top of a lot of different aspects of their project. They need to be tracking costs against budget, delivery against schedule, customer/user expectations, technical delivery of the project and the quality of the outcome, and managing all of these activities within a complex environment of regulatory compliance. This is a lot to think about and Project Manager can be easily distracted from potentially critical issues.
Organisations commissioning these types of projects need to ensure that the Project Managers are not "set up to fail". They need to be provided with the support, systems and tools to enable them to achieve the best possible project outcome. Through our long track record of successful project
deliveries, we have learned that this doesn't have to mean expensive software tools or extensive training, but can be achieved through the effective application of a number of practical concepts and simple solutions.
This presentation explores some proven, practical and effective Project Management concepts and solutions to enable organisations to set their Project Managers up for success!

Speaker: William Cracknell

Continuous Improvement at CSL - Genesis to Revelation!

Synopsis:
A review of the history of the 'Continuous Improvement' journey at CSL

  • Can 'Continuous Improvement' exist in a highly regulated environment?
  • What's worked ....... and what hasn't?
  • The culture and the commitment.
  • Is the latest thing necessarily the best thing?
  • Where are We Now - have we 'seen the light'?

Speaker: Bruce Davis

PQLI Illustrative Example

ISPE's Product Quality Lifecycle Initiative

Synopsis:

This presentation will concentrate on the Illustrative Example from ISPE's PQLI initiative. It will demonstrate a practical and pragmatic approach to interpretation of ICH Q8/Q9/Q10 for a manufactured product covering both Drug Substance and Drug Product.

It will explain how this Example links all the various teams. It will give information on the work done to date on Criticality, Design Space, Control Strategy and Legacy Products. It will provide information on where PAT tools link in to the process.

Speaker: Derek Fitzgerald

GMP - Looking ahead, making the grade, staying there - a Medsafe view

Synopsis:
GMP developments in New Zealand
Medsafe has put in place various changes in the way it manages GMP audit and licensing activities - an updated code of GMP, application for PIC/s membership, a new look for policies and procedures - an update on these new developments.

Making the grade
Achieving and maintaining GMP - some thoughts on the road to GMP, making the grade and maintaining it.

Staying there
Pitfalls and problems - what the GMP auditor and the complaints and recalls officer see - what to avoid, what to encourage - lessons from the audit notebook and the complaints file.

Speaker: Noel Fraser

"What's new in GMP? A TGA perspective"

Synopsis: Synopsis: Since implementing the PIC/S GMP Guide as an Australian Code of GMP in 2002, there have been several revisions of the PIC/S Guide. The current PIC/S GMP Guide is expected to be adopted as a Manufacturing Principle during 2009. The presentation will discuss the implications of the key changes.

Speaker: Andrew Gunst

Carbon Pollution Measurement and Control

Synopsis:
Carbon Reporting and Emissions Trading in Australia have emerged from seeming unlikely in 2007 to mandatory reporting in place on 1 July 2008, with the onus on corporations to determine whether or not they must report, and the possibility of Australia and the USA joining Europe in Carbon Trading in 2010. To date, much of the public discussion in Australia has centred on the financial aspects of a Carbon Tax or Emissions Trading Scheme. But real challenges exist in determining and measuring the emissions that the financial community seek to trade, and understanding of the details at even the highest level of the business community is not strong.

A major life sciences manufacturing operation will be used as an example to explain the challenges of understanding greenhouse gas emissions and their regulation; how the sources of emissions can sometimes surprise; the challenges in emissions measurement; and how those with Pharmaceutical Engineering skills can be key contributors to overcoming these challenges.

Speaker: Mark Hammond

Good Distribution Practices

Synopsis:
Careful temperature control of vaccine shipments has always been a challenge. Now temperature control of all pharmaceuticals has received a growing level of attention over recent years. Regulatory bodies have been further extending their gaze beyond GMP storage locations to the journey in between. This heightened interest is not new but it is becoming more prevalent.

There is an increased awareness of the underlying issues and challenges. With an increased global economy and the greater movement of temperature sensitive products between countries, the opportunity for temperature excursions during shipment is a bigger issue that we need to manage on a day to day basis.

The presentation will outline regulatory requirements and strategies to minimise the risk of product temperature impact. There are three main areas which need addressing: the choice of shipping system, temperature monitoring device to be used and the courier who will handle it.

Speaker: Paul Ives

How Lean is changing traditional supply & manufacturing practices at AstraZeneca Australia

Synopsis:
After several years of implementing a Continuous Improvement / Lean culture at a localised level with some degree of success, AstraZeneca has adopted a standard Lean implementation program that is being rolled out to all supply sites within the global network.
What this has meant for AZ Australia is a focussed approach to the development of 5 key areas - the development of the processes, the information systems, the organisational structure, the people and the capability of its leaders.
The strategy has reinforced the need to continue to make continuous incremental change in the right areas whilst also providing a new framework within which transformational change to these 5 key areas can occur.
This session will describe the core principles underlying the AZ Lean strategy and how this has been applied locally at the North Ryde site.

Speaker: Ivy Leung

Productivity improvments in support areas of Manufacturing

Synopsis:
Indirect areas (non production) have a big contribution to the cost of goods in the pharmaceutical industry. Yet, historically, indirect workload has been less tangible and the processes less visible than in the direct areas. Ivy will present a methodology that she has developed & applied successfully to quantify real indirect workload, streamline indirect processes, generate productivity improvement and making real differences to the business.

Speaker: John Montalto

Alternative Project Delivery Strategies

Synopsis:

  • optimising your processes to reduce waste
  • methods for analysing your most common processes and implementing improvements
  • an overview of '5S'
  • as an industry we are not too often able to construct, build and design a completely new process, so let's maximise efficiencies within our current systems
  • understanding the FDA's draft Process Validation guidance and its application to maximising your current work flows

Speaker: Adrian Oates

The 3C's: how to drive a product through R&D into the global regulatory environment from Australia

Synopsis:
Experience has shown me that there are three key factors ('The Three C's') that when applied will increase the likelihood of success for research products gaining regulatory approval across global markets. The three C's are: Compliance (simple and effective), Culture (capable and committed) and Continuous Improvement (customer focused). Simplification of a Quality System works to align R&D and operational efforts. An emphasis on internal audit serves to maintain a robust foundation. A strong desire to train our people in what is expected of them leads to capable and committed staff. Developing leaders in constructive and collaborative behaviors becomes infectious. Reducing safety risks to patients through design, process or labeling mitigation controls raises confidence that there will be few surprises once the product is in the market. Risk reduction is complemented by CI tools such as LEAN Six Sigma where projects focused on meeting customer delivery targets and reducing process variation lead to meeting customer expectations. This presentation will serve to distill what I have learnt over many years operating from Australia to successfully develop a number of new products launched into local and global markets.

Speaker: Trevor Schoerie

Implementing lean quality management systems

Synopsis:
If you consider that it costs at least $1000 to write an SOP for quality system and that poor documentation is frequently cited during audits, the investment and audit risk is significant. However, a well planned documentation system can be an effective tool in your operations, not only a tool that reduces errors and becomes an invaluable training resource but one that can eliminate your waste using Lean principles. The key is to document best practice, not just standard practice.

A case study will be presented that demonstrates how a company improved the return on investment of their Quality Management System by using value stream mapping as part of their documentation process. Learn how they developed documents that staff actually used and improved their processes to eliminate waste, stream line operations and ensure best practice methodologies are in place.

This presentation will include step-by-step information about how to assess your current business processes, critically review how to improve them and how to demonstrate that it's working.

Speaker: David Selby

Process Validation - The FDA's Draft Guideline

Synopsis:
This presentation will review the recently published draft Guideline on Process Validation from the FDA.

The three stages of Process Design, Process Qualification and Continuous Process Verification will be reviewed in detail.

As well as reviewing the guideline, the comments made by industry bodies and some "personal views will be included to stimulate debate.

Speaker: Marty Siwak

Biomanufacturing and Single Use Technologies : Driving towards Integrated Solutions.

Synopsis:
Single use disposal bags, filters, valves and other components have become enabling technologies for biomanufacturing processes. Currently the ability to fit to a particular process or facility is for the most part a case by case exercise. A review of current usages, economics and trends will serve as a backdrop for a detailed view of several new integrated pre-engineered disposable process unit operations.

Speaker: Gary D. Stewart

ISPE 2009 - Executive Lean Leadership - Learning from the Toyota way

Synopsis:
The desired response to the current Global financial crisis must be to re-invent Manufacturing - and this in turn will require us all to re-invent our companies.

This is a time to breakthrough to new ground - to a new level of manufacturing excellence.

The future must be a decade of Innovation like we have not seen before.

Because, this is not just a recession - this is a new beginning as people change their thinking about how the world works - and the journey to greatness will demand all leaders in turn to change their thinking.

At ISPE 2009 Gary will illustrate how different Executive thinking can drive vastly different outcomes for your business - it is the Toyota Executive way of thinking and behaviours that drives those different outcomes and the spectacular success that Toyota enjoys.

Speaker: Brad Swarbrick

Process Understanding Tools: The Major Pitfalls of SPC

Synopsis:
Process Analytical Technology (PAT) and Quality by Design (QbD) have been buzz words in the pharmaceutical and biopharmaceutical industries for a number of years now and based on the literature and guidance documents available, these initiatives are gaining real momentum. Fundamental to these initiatives are the basics of Multivariate Analysis and Design of Experiments. This seminar outlines some of the practical issues regarding the implementation of PAT/QbD and
looks at the following topics.

  • The pragmatic use of guidance to enable, not hinder, progress
  • The multivariate nature of Design Space as stated in ICH Q8
  • Historical vs. Designed data, challenges and opportunities
  • Variability reduction and the use of Regression Modelling
  • The Concept of Smart Manufacturing and MAFSS
  • Combining information from unit processes to form a process model. The HHL Model
  • Putting it all On-line for real time analysis

Speaker: Sean Thomas

Understanding People Delivers Productivity Improvement

Synopsis:
Understanding the social and emotional needs of people sheds light on the style of leadership and feedback that motivates and engages team members.
This presentation will introduce the human-social factors that determine the degree and style of individual motivation, commitment to the team and willingness to contribute to the success of the team. The topics covered will include sociobiology, control gradients and the characteristics of motivation. Practical guidelines will be provided that will equip attendees with tools that they can put to immediate and effective use.

William Cracknell

William Cracknell

Bill Cracknell graduated from the Victorian College of Pharmacy in 1977.
Bill's career has included included stints in both hospital and retail pharmacy, and operational roles in a number of Australian and multi-national pharmaceutical manufacturers. In 1994, Bill found himself at CSL at a point where that company took the leap from Government owned
authority to publicly listed company.

The ensuing years have seen CSL grow to a position of prominence as a truly global player in the bio-tech industry. As a senior leader in the Australian vaccine business, Bill has a had a unique opportunity to oversee a period of remarkable growth and development.

Justin Daly

Justin Daly

Hospira Australia Pty Ltd.

Justin Daly has over 15 years of experience in the Global Pharmaceutical Industry and is currently the VP Manufacturing Asia Pacific region. He has a degree in Science with Honors and an MBA from Monash University (Melbourne, Australia). He began his career in the early 1990's working with various manufactures joining Faulding Pharmaceuticals in 1993. Faulding was acquired by Mayne and subsequently acquired by Hospira in 2007. During his career the focused has been on manufacturing of small volume injectable products for the US, EMEA, Canadian, Asian and Australian markets. Experience has been gained on a product range which includes oncology, anti-infective and specialty molecules. He has worked with a wide range of presentations including plastic ampoules, bags, syringes and vials. At various times he has work in Australia, Puerto Rico and Europe and had responsibilities for Production, Engineering, Validation, Packaging, Site Operations and Corporate support functions.

Derek Fitzgerald

Derek Fitzgerald

Manager, Compliance Management Branch Medsafe, New Zealand Ministry of Health

Derek Fitzgerald manages the Compliance Management Branch at Medsafe, New Zealand's Medicines and Medical Devices Safety Authority. Compliance Management staff are engaged in diverse areas of therapeutic products regulation including: management of medicines and medical devices complaints and recalls; GMP auditing and licensing; testing programme management; medical device post-market activities and investigation, enforcement and prosecution activities.

He is a pharmacist with further qualifications in business and administration and in industrial production. He joined the then Department of Health as a GMP auditor in 1992 having worked in retail and hospital pharmacy as well as the medicines manufacturing industry and having spent time working in Great Britain and the Middle East. He has a particular interest in manufacturing and GMP auditing.

Tony Gould

Tony Gould

Chief Auditor, Office of Manufacturing Quality

  • Pharmacist
  • Work experience includes hospital pharmacy and community pharmacy, lecturing (pharmaceutics) and Production Manager of a multinational pharma company.
  • Joined the TGA in 1991 and became Chief Auditor in 2003.
  • During 2008 spent 6 months working for the WHO Prequalification Programme in Geneva as Quality Systems Manager and Senior Auditor.

Andrew Gunst

Andrew Gunst

Andrew Gunst is CEO of Carbon Intelligence, who assists organisations to measure and manage their Carbon emissions. Andrew has a decade of experience in pharmaceutical and life science organisations at Managing Director and General Manager level. He has managed operations in several countries to Australian TGA and US FDA regulations including the manufacture of API, pharmaceutical, OTC, medical device and cosmetics products. He has also managed projects, Information Technology and Research & Development in the brewing, chemical, food & logistics industries. Andrew is a Bachelor of Chemical Engineering with Honours, majoring in Environmental Engineering, and is a Master of Business Administration.

Mark Hammond

Mark Hammond

Mark is the Quality Assurance Manager responsible for product quality at Merck Sharp & Dohme, a subsidiary of the pharmaceutical company Merck. With over 20 years experience with Merck, he has gained vast knowledge in pharmaceutical manufacturing and product distribution. With his background in packaging, operations improvement and certification in Six Sigma Lean Black Belt, he has focussed strongly on system optimisation and waste reduction, while maintaining a high level of compliance.

Tony Broughton

Tony Broughton
  • Tony Broughton is currently the Director of Supply & Manufacturing for AstraZeneca, North Ryde, and is also a member of the AstraZeneca Senior Management Team in Australia and the Regional Leadership Team for Asia Pacific & Japan.
  • His responsibilities include leading the manufacturing division, being responsible for all manufacturing functions, and liaison with global supply sites, strengthening AstraZeneca's position in the global market.
  • Tony joined AstraZeneca in 2005. He has extensive pharmaceutical and FMCG experience gained from a career with Schering-Plough, Lion Nathan, and Dairy Farmers in Plant Management and Engineering roles. He holds a Bachelors Degree in Mechanical Engineering.

Dig Howitt

Dig Howitt

Dig Howitt is Senior Vice President, Manufacturing and Logistics for Cochlear Ltd. He has responsibility for Cochlear's supply chain including two manufacturing sites employing over 600 people. Cochlear performs all manufacturing in Australia and exports over 95% of production to over 80 countries. Dig joined Cochlear in 2000. Prior to this he worked with the Boston Consulting Group, Boral and Sunstate Cement. Dig holds a Bachelor of Engineering (Hons) in Electrical Engineering from the University of Sydney and a Masters of Business Administration from Stanford University in the USA.

Paul Ives

Paul Ives

Paul is the Operational Excellence Manager for AstraZeneca Australia. Being relatively new to the Pharmaceutical Industry, Paul has a vast knowledge of Lean and Continuous Improvement from several years working for a major automotive company in the UK. His previous roles have included line engineering, continuous improvement project management and production management.

His team are currently leading a Lean programme within AZ that focuses on the development of the five fundamental areas of systems, processes, leadership, organisation and people.

Bernard Kornfeld

Bernard Kornfeld

Bernard is a seasoned process excellence professional - a Six Sigma Master Black Belt and Lean practitioner with over 14 years experience managing projects, programmes and deployments in Australia and abroad for Merck, the Commonwealth Bank and Baxter Healthcare. His work has spanned across manufacturing operations, insurance, banking, operational risk management, financial services, quality management and logistics. This experience has taught Bernard that most technical issues can be overcome, but the keys to sustaining success lie in leadership, culture and strategy. Bernard has a BSc(Hons), MBA, MBT and MSc. You can find Bernard at http://www.linkedin.com/in/bernardk.

Edward Jones

Edward Jones

Edward Jones has over eight years experience in computer systems validation within the pharmaceutical and medical device manufacturing industry. During this time he has worked directly within pharmaceutical companies and also in a consulting capacity to validate a broad range of business, laboratory, and process automation systems. Edward is currently the Validation Manager at CSL Biotherapies, and is responsible for all validation activities within the company. He has also been Manager of Software and Automation Validation at CSL Biotherapies, responsible for all GxP computerised system validation within the company. CSL's computerised systems are validated to meet requirements defined by a number of regulators including
the TGA and FDA.

Adrian Oates

Adrian Oates

Adrian Oates is the Vice President of Quality and Regulatory of Universal Biosensors, a specialist medical diagnostic company located in Australia focused on the commercialization of a diverse range of point-of-care diagnostic tests. Adrian achieves success by combining his extensive practical R&D experience with an expertise in compliance and regulatory approval processes, project and risk management and quality assurance, all gained from being in the medical device and pharmaceutical industries for over 20 years. Adrian's recent successes include:

  • Building a robust global Quality & Regulatory framework and infrastructure within Universal Biosensors to help grow a research and development company into a commercial organization with operational credibility for a global market;
  • Leading a cross-functional project team to achieve FDA accreditation as CSL Biotherapies Quality Director;
  • Achieving global compliance and registration approvals of a novel sterile implantable medical device as Vice President of Quality & Regulatory at Cochlear Limited.

Adrian holds a BSc (Biochemistry/Microbiology), a Master of Science (Preliminary) and a Doctor of Philosophy (Medicine) from Monash University.

Trevor Schoerie

Trevor Schoerie

Trevor Schoerie has 30 years of experience in the production, engineering and quality processes and facilities used by the pharmaceutical industry. He is a Director of PharmOut, a consultancy specialising in practical, cost effective compliance for the pharmaceutical and medical device industries. Schoerie has been responsible for driving the implementation of practical, simple GMP, Validation and Regulatory solutions in many companies, both as a consultant and as an employee. He has experienced the pain of non-compliance and is passionate about the use of simple, sustainable quality systems that deliver real benefits. Schoerie is a practitioner of process improvement, using Lean principles and believes in using these principles to make the Australian pharmaceutical industry more competitive. He serves on the board of the ISPE in Australia and travels extensively, supporting clients across the Asia Pacific region.

Marty Siwak

Marty Siwak

Marty Siwak is currently WW Director of the Biomanufacturing Science Network .This group of 60 engineers and scientists is responsible for the hands on development, design and implementation of purification and separation processes in the biopharmaceutical industry. Mr. Siwak has been involved in applied separations for 31 years ,the past 26 years at Millipore. He has worked world wide with many biotechnology and pharmaceutical companies implementing industrial scale separation technology. He has degrees in both Chemical Engineering and Biochemistry from the University of Connecticut.

Gary D. Stewart

Gary D. Stewart

Gary Stewart is a 22 year veteran of executive learning and development in the Toyota group.

Gary acquired his vast Lean knowledge under the tutelage of a Master TPS Sensei while working in Denso - a Toyota group Company - for 11 years.
Because of the circumstances at the time he learned the original 'tough" Toyota version of TPS and Lean in the turnaround and transformation of a Toyota business that was failing.
In effect, having to re-start the whole process of TPS and Lean again from scratch - thereby learning the full secrets of proper implementation at the three discrete operational levels from Toyota along the way.

Later this included a Lean transformation of a sales & engineering organisation, and a Lean reorganisation of the total corporate Denso group which is where he was exposed to the high level thinking of the Toyota Executive Leadership mindset which is the "real secret" factor that drives Toyota's unique global success.

Gary then spent 5 years with a local company transforming the business and more recently at a Greenfield Manufacturing transformation for another Toyota Group company.

He is a frequent speaker in Australia and overseas at conferences covering automotive, manufacturing, (via AME & Lean.org) pharmaceutical, sales and banking.

Even today, after 22 years of learning, Gary remains a serious student of the Toyota Way of business leadership.

Gary will show what businesses must do if they want to take the "high road" to a "new manufacturing world", and how to emulate the spectacular success of Toyota within their own businesses, with special emphasis on understanding the role of the "high level Executive mindset" that is responsible for the type of leadership of innovation and human development that is the direct cause of Toyota's global business success

Brad Swarbrick

Brad Swarbrick

Pharmaceutical Business Development Manager CAMO Software.

Brad Swarbrick has over 15 years experience in the use of multivariate data analysis methods in food, agriculture and pharmaceuticals. Prior to CAMO, he worked as part of the Pfizer PAT group, Sigma Pharmaceuticals and was an industry consultant with one of SE asia's largest pharmaceutical
consultancies.

Sean Thomas

Sean Thomas

Sean Thomas has had a long term interest in motivation, particularly motivation in the workplace. He has developed an understanding of the factors that influence motivation and what an organisation can do to ensure that it's staff are optimally motivated and are focused on appropriate outcomes.

Sean spent over ten years in Australia developing and implementing systems to increase motivation in the workplace, particularly in manufacturing organisations. The systems, which included both a consulting and software component, broke new ground in the application of psychology on the factory floor and were widely successful.

Since returning to New Zealand Sean has established Tima Consulting and resumed consulting to organisations in the areas of motivation and communication. Tima Consulting develops productivity feedback and workplace collaboration tools as well as strategies to improve work team performance by leveraging human-social factors.

Sean is also an accomplished public speaker whose topics include: motivation in the workplace, social influence, and an entertaining look at socio-biology and existentialism. Sean is also able to develop presentations and workshops on related topics as requested.

Stephen Williams

Stephen Williams

Steve has over 35 years experience in the Biotechnology, Pharmaceutical and Medical Device industries in Quality Assurance, Manufacturing and Consulting. He has conducted numerous FDA and EU/TGA/PICs compliance audits and gap analysis for many international companies as well as
developed multiple training courses for GMP, GLP, Validation, Risk Management, HACCP and Medical Devices. He regularly presents at conferences and industry seminars on a range of subjects relating to QA, Risk Management and GMP compliance. He also specialise in e-Learning compliance training solutions for the Life Sciences Industry.

Steve has consulted in GMP, QSR/QA, GLP and Validation since 1989 and has prepared many companies for regulatory inspections. Steve is also a registered auditor for the Australian Pesticides and Veterinary Manufacturing Authority (APVMA) and, in this role, conducts GMP licensing audits on behalf of the Australian government.

GAMP 5 Workshop

Sunday 13th September 2009

Speaker: David Selby

Programme

12:00 -12:45 Welcome and Introduction
Notes: It is assumed delegates will be familiar with GAMP 4

12:15 - 13:15 What's new in GAMP 5?
Notes: It is assumed delegates will be familiar with GAMP 4

13:15 - 13:45 Teamwork 1: What to you like/not like?
Notes: Delegates will be asked to record what they like and do not like about GAMP 4 and why. This will be fed back to the chair, recorded and discussion will follow.

13:45 - 14:30 Validation Planning and Scaleability

14:30 - 15:00 Break

15:00 - 15:45 Teamwork 2: Scaling Validation
Notes: Delegates will plan the validation of a PAT application for the manufacture of an API and plan in more detail the validation of one of the computer or control systems involved.

15:45 - 16:30 GAMP "Hot Topic" Appendices"

16:30 - 17:00 Does GAMP 5 save money - a Case Study

Workshops

1. Verification - the new way using E2500
2. RiskMaPP - Determining operator and product risks

Sunday 13th September 2009

Speaker: Bruce Davis

Programme

12:00 - 12:15 Welcome and Introduction

12:15 - 12:45 Verification - the new approach to verification, based on E2500

12.45 - 14.30 Teamwork1: Assess the differences between traditional qualification and this new approach. Prepare a product based user requirement for a unit manufacturing operation.

14:30 - 15:00 Break

15.00 - 15.30 RiskMaPP - balancing health/hygiene and GMP requirements

15:30 - 16.45 Teamwork 2: Assess the risks for potential operator and product cross-contamination in a multi-product plant. How are these risks mitigated?

16:45 - 17:00 Wrap-up

Notes:

The workshop will:-

1. Explain the major changes brought about by E2500 and the way in which these new principles can be used in practice, thus giving major savings and clarity on verification
2. Explain a logical approach to balancing health and hygiene requirements and give an exercise on how these can be applied in a multi-product plant

Certified Pharmaceutical Industry Professional Introduction Workshops

Speaker: Stephen Williams

A workshop will provide an overview of the CPIP - an exciting, internationally recognized credential made available through the ISPE Professional Certification Commission. Topics include: a CPIP introduction and eligibility criteria, Also, guidance on "how to" submit a CPIP eligibility application and prepare for the CPIP examination. Topics include: obtaining a University transcript, completing the professional experience forms, utilizing the CPIP Study Guide resources CD ROM, and organizing CPIP study groups. Visit http://www.ISPE-PCC.org for more information.

ISPE Student Poster Competition

Student poster competition is a regular event at our conferences. We expect submissions from University Students from Australia and New Zealand universities. They will showcase visual displays of their research or program highlights and these talented Student Members present their work before a panel of industry judges and attendees are able to view the posters throughout the meeting. ISPE will announce the winner of the poster competition during the conference.

Winners receive a monetary prize and recognition in ISPE publications and/or newsletters. Participants have the opportunity to publish an article based on their poster presentation in ISPE's Pharmaceutical Engineering magazine or the Journal of Pharmaceutical Innovation.

Leadership Forum

Tuesday 15th September 2009

Chair: Robert W Tribe

15:10 - 16:50
Leadership Forum

Introduction: At the 2007 Australasia Conference on the Gold Coast the events committee introduced an innovative one hour session called the "Leadership Forum". This forum was scheduled under Stream 2 - Manufacturing Excellence and was chaired by Malcolm Holmes, Director of Quality Assurance, GSK (UK). The panel included a number of site operations leaders from Pharmaceutical, Biotech and Medical Device manufacturing companies and included Tony Gould, Head Auditor,TGA. Malcolm asked a number of interesting questions centred around; innovation, opportunities, threats, operational excellence initiatives facing their businesses and the relationship with regulatory authorities. The questioning was then opened up to the audience. The overall feedback from delegates at the conference was extremely positive but the feedback was the one hour session was too short.

ISPE Australasia has recognised a need for this type of forum going forward and based on feedback is pleased to announce that the "Leadership Forum" will be a two hour session at the 2009 ISPE conference.

Purpose: The purpose of continuing these leadership forums is to bring the site operations leaders of Pharmaceutical, Biotech and Medical Device manufacturing companies in Australia / NZ and Regulatory bodies together to discuss issues associated with continual pursuit of operational excellence. These forums will allow for debate but are expected to be orientated in
support of the goal.

Goal: To support and continuously improve the Pharmaceutical, Biotech and Medical Device manufacturing industry in Australia and New Zealand.

The Chair for 2009 will be:

Senior Leaders confirmed are:

GMP - Looking ahead, making the grade, staying there - a Medsafe view

GMP developments in New Zealand

Medsafe has put in place various changes in the way it manages GMP audit and licensing activities - an updated code of GMP, application for PIC/s membership, a new look for policies and procedures - an update on these new developments.

Making the grade

Achieving and maintaining GMP - some thoughts on the road to GMP, making the grade and maintaining it.

Staying there

Pitfalls and problems - what the GMP auditor and the complaints and recalls officer see - what to avoid, what to encourage - lessons from the audit notebook and the complaints file.

Robert W Tribe

Robert W Tribe

Regulatory Affairs Advisor, Asia Pacific ISPE

Robert Tribe has been a GMP Consultant to regulatory authorities since August 2004. He retired from the Therapeutic Goods Administration (TGA), Australia in July 2004 after holding the position of Chief GMP Auditor at TGA for 24 years. He joined the TGA in 1971 as a GMP inspector, after working in the pharmaceutical industry for six years in a Quality Assurance position.

He was the recipient of the 1999 Australia Day Achievement medallion for contributing to the successful negotiation of the MRA (mutual recognition agreement) for medicinal products between Australia and European Union. In 2004 he was the recipient of the FDA Commissioner's special citation Award as a member of the ICH Q7A Expert Working Group ("for outstanding cooperation and achievement in developing internationally harmonised good manufacturing practice guidance for active pharmaceutical ingredients used in human drug products"). In 2005 he was the recipient of the John Martin Memorial Award issued by the NSW Pharmaceutical Science Group of The Royal
Australian Chemical Institute ("For exceptional leadership and service to the Australian Pharmaceutical industry").

He has been involved with PIC/S since 1986 and was Deputy Chairman of PIC/S during 1998-1999 and the Chairman of PIC/S during 2000-2001. He currently consults to regulatory authorities around the world providing advice on their readiness for PIC/S membership, as well as conducting GMP training for the GMP inspectors and industry personnel in those countries. He also provides GMP consultancy to manufacturers of medicines.

He is currently a member of the WHO Expert Committee on Specifications for Pharmaceutical Preparations and was Rapporteur for the Committee in 2001 and 2004. He also participates as an expert GMP inspector under the WHO prequalification programme.

He became ISPE's Asia-Pacific Regulatory Affairs Advisor in July 2004. Robert will be the moderator for the Leadership Forum on Tuesday, 15 September, 2009

Ivy Leung

Ivy Leung

Ms Ivy Leung holds a BSc and a Master of Chemistry degree. She has worked in GlaxoSmithKline for over 17 years, having held management roles including Compliance, QC, Quality Systems, Tablets Manufacturing & Dispensary. Over the last 5 years, Ivy has been working as an Operational Excellence Expert, leading & influencing continuous improvement, generating insights, managing change, coaching & mentoring. Ivy is a certified Lean Blackbelt.

Ivy was awarded the Glaxo Manufacturing Services Site Director Award in 2008 for her productivity improvement work in QA. The QC Laboratories in Boronia was certified as "Class A Laboratories" in May 2008, 2nd in the GMS network and the 1st including a Microbiology Laboratory.

Kylie Brailsford

Kylie Brailsford

Kylie has over 15 years experience in the life sciences industries, working both directly for a large manufacturing organisation as well as with consultancies in Australia, Singapore and Ireland. Kylie is currently the manager of the Project Management Office of Synertec, an Australian owned engineering & GMP consultancy with operations in Melbourne, Sydney, Queensland, Singapore and Malaysia. Kylie has managed a variety of projects, specialising in automation projects and including all phases from project initialisation through to construction and handover. Kylie currently has key responsibilities within Synertec for streamlining project management systems and providing mentoring for other project managers.

Chris Proctor

Chris Proctor

Chris Proctor is Director of Sales, Marketing and Client Services for IMS Health ANZ. He has particular expertise in business strategy, sales, and marketing and is also a trained facilitator. Chris has worked with clients at all levels in the Asian region, managing projects in a variety of markets including Australia, China, India and Korea, where he was Consulting Practice Leader in the Asia Pacific region.

Chris’s background includes extensive experience in business strategy, product and portfolio development, sales and marketing effectiveness, targeting and segmentation, sales training and change management. He has in-depth knowledge of pharmaceutical business management gained in over 16 years at Merck Sharp and Dohme in positions spanning sales, business analysis and health economics.

In 1999, Chris was appointed manager of New Business Development at Battaerd Mansley where he played a key role in the successful launch of several new products in Australia. He joined IMS in 2002 following the company’s acquisition of Battaerd Mansley, and is a regular speaker at major conferences in the Asia Pacific region.

Chris holds a Master of Science degree in Physiology, and an MBA from the University of Technology in Sydney with a major in business strategy. He also has a graduate diploma in Marketing and an undergraduate degree in Applied Science.

Jason Kelly

Jason Kelly

Jason Kelly is an Electronic Engineer with over 14 years experience in the design and installation of Environmental Monitoring Systems (EMS) to comply with regulatory guidelines.

As Director of Optical Sciences Ireland in 2003 he has installed multiple EMS across Europe with many leading Pharmaceutical Companies such as Pfizer, Wyeth, Baxter, GSK, ELAN, Eli Lilly, Boston Scientific using leading technologies such as wireless environmental sensors and combining monitoring of viable and non viable particles using innovative design and technologies.

Currently at Kenelec Scientific Jason is Project Manager on a number of on-going EMS projects in Australia. Jason has also presented at many Industry Seminars including the recent Australian Cleanroom Technology Seminar focusing on Environmental Monitoring recently held in April 09 he also has written many technical articles dealing with viable and non viable monitoring which have been published in Industry Journals Worldwide.

Noel Fraser

Noel Fraser
  • GMP Auditor with Therapeutic Goods Administration since 1998
  • Prior to TGA 13 years in industry, in the manufacture of non-sterile and sterile finished dosage forms, and APIs. Range of roles including QA, Production and Regulatory compliance.
  • BSc (Hons)

Ross Chester

Ross is a Senior Engineer with 20 years experience in leading pharmaceutical organisations including validation and internal audit with CSL and quality systems, regulatory compliance, project management, equipment qualification and process validation with Mayne Pharma Ltd (formerly F. H. Faulding).Currently he is preparing PolyNovo Biomaterials' quality system for certification at their new facility.

He has a track record of successful project management for both change to business processes and the introduction of new capital equipment. This has been coupled with the development of teams to achieve completion often with tight time frames and limited resources.

John Montalto

John Montalto is a training manager with PharmOut Pty Ltd, one of the largest GMP and regulatory consultancies in the Asia-Pacific region. John routinely trains and consults to multinationals, regulatory agencies and small business in pharmaceutical validation, project management, quality management systems and risk management.
John has had extensive 'in the trenches' experience and line responsibility for the delivery of several 'turn-key' projects within vaccine, device and anti-viral manufacturing facilities. John has also served a valuable apprenticeship outside of the life sciences industry enabling him to 'cross pollinate' his experiences.
During his time at Kodak, John was able to implement and develop lean manufacturing projects, including 5S upgrades, Kaizen events, lean manufacturing and 'just-in-time' chemical delivery processes. Additionally, John spent several years in pharmaceutical production management roles implementing and maintaining quality management systems, and leading major scale validation projects.
John now focuses on transferring his experience through training and improving the skills of regulated industry personnel throughout Australia, New Zealand, Asia and South Africa. John has developed a reputation for his 'active' style of presentation and has delivered an array of training presentations in many topics including:

  • good manufacturing practices
  • quality risk management
  • computerised systems validation
  • process and equipment validation
  • lean manufacturing.

Over many years, PharmOut have developed a series of professional development training programs. These range from on-site and off-site training courses, and e-learning modules. John has played an instrumental role in developing these with Bob Tribe, ex TGA, Head of the GMP compliance.
John is a current Director of the Australian affiliate of the International Society of Pharmaceutical Engineering and a consultant to the Food and Agriculture Organisation of the United Nations.

Kylie Sproston

MEng(Hons) MSc CEng MIMechE General Manager, BTG Australasia P/L

Kylie joined BTG/Protherics as General Manager in January 2007 from previous roles within AstraZeneca in the UK. She is responsible for all Australasian operations and sits on the BTG Global Operations Executive Team.

A Chartered Mechanical Engineer by profession, Kylie brings experience of various manufacturing environments, and specialist knowledge of the blue chip pharmaceutical industry in Europe. Her experience covers the full life-cycle of the pharmaceutical business covering facility specification, design and construction, operational management and support functions such as maintenance, quality, validation and project management functions.

Kylie has a passion for the pharmaceutical industry, and an excitement for both the products and the teams involved. She has a strong track record in project delivery, and solid experience in the various operational aspects required once in operation.

Darren Green

Darren Green - Director Zektingroup.

23 Years experience in a wide range of Pharmaceutical, Biotechnology, Laboratory and Containment facilities in the areas of design, construction supervision and commissioning.

Experience with facilities in Australia, Puerto Rico, Ireland, Germany, Singapore, Thailand, Indonesia, Malaysia, South Korea, UAE & China

15 Years on the Board of ISPE Australasia Affiliate (member of the start up committee)

Accredited Third Party Assessor for Quarantine Approved Premises for AQIS QC2, QC3 & QC4 facilities.

Client base includes CSL, GSK, Sigma, Pfizer, ARCBS, Herron, MSD, Wyeth, Parke Davis, Biological Therapies, MCRI, VIDRL, Acrux, Agen, CSIRO, DPI and many others.