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Austin Lock
Biopharma Technical Specialist
PM Group |
Date: 31 May 2011, Tuesday
Track: Biotechnology
Topic: "The pro's and con's of Modular Installations in Biopharmaceutical Plant Design, Installation and Commissioning/Qualification"
Austin is a chartered chemical engineer with Masters Degrees in both chemical engineering and pharmaceutical engineering. He has 22 years experience in the process engineering of pharmaceutical facilities. His experience covers secondary pharmaceuticals, biotechnology (including vaccines), and bulk API facility design, working for a number of A/E and manufacturing companies.
He has been the lead process consultant for the design of several major biotech and secondary pharmaceutical manufacturing facilities. He is also very experienced in site master planning, feasibility and concept designs.
Austin was recently a European chapter leader (architectural) for the revision upgrade of the ISPE Baseline Guide for Oral Solid Dosage Forms. He has co-chaired several ISPE seminars focussed on novel approaches and innovation in OSD process technology.
Austin is currently a Biopharma Technical Specialist in PM’s International Consultancy Technology Group.
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Bart Moors
Director global business and project development Life Science
Siemens AG
Germany |
Date: 30 May 2011, Monday
Keynote Plenary Session
Topic: “Digital Plant - Synergies between engineering and manufacturing”
Bart Moors is Director global business and project development life Science for the Siemens. He works for the headquarters of Siemens AG for the sector industry in the vertical Pharma and Life sciences department.He has more than 10 year pharma experience and has been worked in close collaboration with Janssen Pharmaceutica, Genzyme, Pfizer, Baxter, Schering & Plough and many more.
He started his profession in the chemical industry and secondly build up experience in the automotive industry before he joined Siemens.Bart has a Masters degree in Electrical-Mechanical Engineering, a specialism in Polymers and a Masters degree in Applied Economics. |
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Case Ferguson
Director of Business Development APC
Camfil Farr Asia |
Date: 30 May 2011, Monday
Track: Operational Excellence
Topic: “Energy reduction in filter systems for pharma applications”
A graduate of The University of Alabama (1998), USA, Case Ferguson is currently the Director of Business Development, Camfil Farr Malaysia Sdn Bhd. As the Director of Sales for APC products Case is responsible for developing sales for Camfil Farr’s Air Pollution Control division that focuses in the pharmaceutical market segment. He, his wife, and four children reside in Kuala Lumpur, Malaysia.
Camfil Farr Malaysia Sdn Bhd is part of Camfil AB based in Stockholm, Sweden. With sales approaching one billion USD, twenty-three production plants and R&D centers in the Americas, Europe and Asia-Pacific region Camfil is focused on providing superior clean air solutions for the Bio-Pharmaceutical, Hospital, Commercial, Food & Beverage, Microelectronic and Power System market segments. |
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Darren Freestone
Senior Consultant
SeerPharma |
Date: 29 May 2011, Sunday
Workshop 1
Topic: “Behavioural GMP – Breaking the Fire-Fighting Cycle”
Over 23 years experience in the Pharmaceutical industry in multinational companies in Quality Assurance, Sustainable Compliance, Manufacturing, and Laboratory Management holding senior QA positions. Darren has implemented a sustainable compliance initiative for a multinational pharmaceutical company based on best practice FDA standards. Darren has been responsible for co-ordination of technical transfers, including transfer of solid dose, oral liquids and steriles in Thailand and Korea and the integration and start-up of new facility (Vietnam). Darren also has extensive experience in compliance auditing while employed by the Therapeutic Goods Administration (TGA) as a GMP auditor. In this role Darren was responsible for regulatory audits to PIC/S / TGA cGMP both within Australia and in the Asian region. Integral to this role was a risk based compliance assessment program. Darren has a strong background in USFDA quality systems, Australian / PIC/S cGMPs and ASEAN requirements for pharmaceutical production and in his current role has worked with companies to implement these standards in Asian countries such as Singapore, China and Thailand. Darren also regularly conducts GMP training both publically and enterprise-based. |
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David Paspa
Senior Consultant
SeerPharma (Singapore) Pte. Ltd |
Date: 31 May 2011, Tuesday
Track: Operational Excellence
Topic: “Does local productivity really optimise overall business performance?”
David Paspa B.E. (Hons) is a Senior Consultant at SeerPharma (Singapore) Pte Ltd. He has worked in the Pharmaceutical and Biotechnology industries since 1990 on large and small projects for the manufacture of sterile and solid dose products, veterinary products and APIs.
His involvement has been in the areas of process control and IT software specification, design, development and commissioning with an emphasis on validation. David has also been involved in process engineering activities, including plant modelling, throughput optimisation and de-bottlenecking. He has worked as both a client and a supplier.
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Donald Grubb
Senior General Manager
Pharmaniaga LifeScience |
Date: 31 May 2011, Tuesday
Track: Operational Excellence
Topic: "The Road to Commercialisation for a Malaysian Injectables Fill and Finish CMO"
Don joined Pharmaniaga, Malaysia’s number one integrated pharmaceutical company in February 2009. He is the Senior General Manager of Pharmaniaga LifeScience a new Small Volume Injectables Fill and Finish Contract Manufacturing Organisation.
Don is a manufacturing specialist with over 30 years experience in the pharmaceutical industry, he is a specialist in sterile production, solid dose manufacturing and in barrier isolator technology. He has held various positions as general manager, consultant, manufacturing manager, project manager and process engineer and has worked for most of the multinational pharmaceutical companies. At Sanofi Aventis (formerly Rhone Poulenc Rorer) he ran the UK manufacturing facilities for tablets and injectables. At Raytheon Engineers and Constructors he was an international pharmaceutical consultant specializing in hi-tech, materials management, manufacturing excellence, strategic development, performance improvement, facility design and operation and validation based projects. Don has made major contributions to facilities in Europe, Middle East, India, Far East and Africa. He has written various pharmaceutical presentations and publications. He now leads Pharmaniaga LifeScience establishing a ‘state of the art’ contract manufacturing business for the fill and finish of parenterals in Malaysia. |
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Dorai Sridhar
Director of Engineering
Lonza Biologics Singapore |
Date: 31 May 2011, Tuesday
Track: Biotechnology
Topic: Start-up of a large scale biologics facility - Challenges & Strategies
Sridhar Dorai is the Director of Engineering at Lonza's large scale biologics facility in Singapore. A mechanical engineer by training, Dorai has 25 years of experience in engineering, operations and projects in biologics, pharma and other industries.
At Lonza, Dorai was part of the team that was responsible for the build-out, Commissioning, Qualification and Start-up of the first large scale biologics facility in Singapore. After the completion of the project phase, he had been part of the operations team of this facility before its transition to Roche. Subsequently, he was part of the team that was responsible for the build-out, Qualification and Start-up of the second large scale biologics facility in Singapore, which belongs to Lonza. Prior to joining Lonza, Dorai has held similar positions in a CRO as its Director of Engineering and in A-Bio Pharma's first biologics facility in Singapore as its Head of Engineering. |
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Goh Chye Guan
Director (Industry Capability Building)
Workplace Safety and Health Council of Singapore |
Date: 30 May 2011, Monday
Keynote Plenary Session
Topic: “An Overview of the Singapore Workplace Safety and Health Strategy and Its implication to the Pharmaceutical Industry”
Goh Chye Guan is currently the Director (Industry Capability Building) of the Workplace Safety and Health Council of Singapore. Chye Guan is a Mechanical Engineer by training, and has a Master of Science in Industrial Engineering as well as a Master of Business Administration. He has more than 25 years of wide ranging experience in workplace safety and health (WSH) and risk management both locally and regionally, both from the public as well as the private sectors.
He started his career in 1985 with the then Ministry of Labour’s Occupational Safety Department. He subsequently joined the private sector working for a Norwegian consultancy company Det Norske Veritas (DNV) in 1992 and was the General Manager of a subsidiary of the Singapore Contractors Association before he set up his own risk management consultancy company in 1999. In his career, he has trained, consulted and audited companies in the onshore and off-shore sectors, oil and gas, petrochemical, mining, manufacturing, construction, marine and port services. Chye Guan re-joined the Ministry of Manpower in 2005 when the WSH Advisory Committee was first formed. His current portfolio focuses mainly on the building of WSH Capability of people and enterprises. |
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Janson Yap,
Regional Managing Director,
Enterprise Risk Services Life Sciences & Healthcare SEA,
Deloitte & Touche Enterprise Risk Services |
Date: 30 May 2011, Monday
Keynote Plenary Session
Topic: Industry Overview: “Trends of Pharmaceutical Manufacturing in Asia”
Janson heads the Process and Life Sciences industry practice in South East Asia for Deloitte Consulting in addition to his role as Managing Director for the Thailand practice. In his role as Industry Practice Leader, his key responsibilities include developing and expanding Deloitte’s consulting market share, revenue and competitive position in this sector. Over the last few years, Deloitte’s presence in the Life Sciences and Healthcare has grown significantly as demonstrated by revenue growth and eminence contribution to the overall regional practice. The target growth of this sector is above 20%.
His Key clients include AstraZeneca and Novartis where he serves as Lead Client Services Partner for these accounts in South East Asia. Together with his global colleagues, he brings a seamless global cross function capability to serve clients.
He has led many business transformation programs in recent years looking at Go-To-Market strategies, Business Models, CFO Transformation, CIO Transformation and large scale ERP / Human Capital Improvement Programs.
He has over 16 years of corporate experience working in various companies in Asia and Australasia before his return to Asia in 1996. He was recruited by Arthur Andersen (AA) to assist the setup of its technology consulting practice in Malaysia, a model which he then duplicated throughout SEA in AA.
From a consulting experience standpoint, he was recruited to join PwC and subsequently Deloitte to help expand its manufacturing practice in 1999. This team is instrumental in creating a solid regional consulting business presence in this region. He therefore has both strong organizational management skills and has high entrepreneurial business acumen. His strengths are in developing practices and building businesses. |
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Jean-Francois Duliere
Senior Pharmaceutical Process Technologist
Technip Life Sciences
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Date: 29 May 2011, Sunday
Workshop 2
Topic: "Designing and Validating a PIC/S Compliant Manufacturing Facility”
Date: 31 May 2011, Tuesday
Track: Biotechnology
Topic: "Biotechnologies and disposable Equipment: Impact on Facilities Design"
Jean Francois Duliere is a senior pharmaceutical process technologist in TECHNIP Life Sciences Business Unit. He is charge of pharmaceutical processes lay out design and Site Master Plans. He has 10 year experience in Pharmaceutical buildings design. He has been involved in several projects out of France for vaccines, OSD plants, Aseptic Filling.
Prior to joining TECHNIP Jean Francois was Industrial Development manager in Fournier Pharma (France). He has been involved in drug product scale up and validation for OSD and aseptic filling products and has as well to manage industrial scale up QC Lab. Prior these activities he has been responsible for QC Lab and after for 12 years production manager.
He is graduated from Pharmacy University in Marseille and has Master for Drug Products Analytical Control. |
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Jennifer Roodt
Senior Quality Manager
External Supply Integration, Asia Pacific.
Janssen Pharmaceutical Companies of Johnson and Johnson |
Date: 30 May 2011, Monday
Track: Operational Excellence
Topic: “Contract Manufacturing: Opportunities, challenges and trends – a MNC perspective”
Jenny Roodt is a Senior Quality Manager for Johnson & Johnson, responsible for External Manufacture of pharmaceutical products in Asia Pacific. She has been working with external manufacturers in the AP region since 2006.
Jenny first started her career in the pharmaceutical industry in South Africa where she worked as Laboratory Manager and then Quality Assurance Manager at Hoechst Pharmaceuticals. She then immigrated to New Zealand where she worked for Merck Generics, now part of Mylan Laboratories, as Technical Manager responsible for generics product development, validation, new product introduction, technology transfer, Quality Assurance and regulatory compliance for products marketed in Australia, New Zealand, Canada, Europe, Hong Kong, Malaysia, Ireland and United Kingdom.
Jenny joined Johnson & Johnson in Singapore just over 3 years ago. Her expertise covers all small molecule finished product dosage forms. |
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Johann Bonnet
Market Manager
Veolia Water Solutions & Technologies |
Date: 30 May 2011, Monday
Track: Operational Excellence
Topic: “Sustainable manufacturing by reducing, reusing and recycling water”
Johann Bonnet joined Veolia Water Solutions & Technologies in 2001 as Sales Engineer. Johann took over, in 2006, the responsibility of the pharmaceutical market of Veolia Water Solutions & Technologies (VWS) as global Market Manager and joined the corporate Industrial Marketing. Main responsibilities include Marketing and Communication, Key Account Management, sales strategy and support for major international pharmaceutical projects.
He has 14 years of experience in Sales in Food & Beverage and Pharmaceutical industries. Prior to joining Veolia Water Solutions & Technologies, he held the positions of Sales Engineer with Tetra Pak Hoyer and Product Manager with Tetra Pak Processing in France.
Johann has professional membership with ISPE. Recently, he conducted several presentations about Critical Water Utilities, outsourcing and sustainable development for ISPE, Interphex and Achema conferences. |
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Kamalesh Sengothi
Quality Risk Manager
Roche Singapore Technical Operations |
Date: 31 May 2011, Tuesday
Track: Operational Excellence
Topic: “Quality Risk Management: Applications in Regulatory Filing”
Kamalesh Sengothi is the Quality Risk Manager for Roche’s bulk API (E-coli and CHO) facilities in Singapore. He was responsible for the development and deployment of Quality Risk Management (QRM) Program in Singapore that includes business processes, tools, templates and training. He supports all QRM activities for the site inclusive of integrating QRM into routine business processes and the Quality System.
Prior to joining Roche in 2009, Kamalesh has worked for 10+ years at MSD, Singapore with professional experience in the areas of Plant Start up, Commissioning and Qualification, Validation, Technology transfer, Manufacturing and Lean/ Six Sigma.
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Michelle Peake
Chief Operating Officer
Alpha Biologics |
Date: 31 May 2011, Tuesday
Track: Biotechnology
Topic: “Technology Transfer: What does it all mean?”
Michelle is the Chief Operating Officer of the Alpha Biologics Group. She joined Alpha Biologics in November 2003 as the Director of Manufacturing in Penang, and has since been based there being responsible for establishing the company, including overseeing the construction, IQ and OQ of the facility. In 2008 she was promoted to her current position of COO, and is heads up both the Malaysian and UK operations. She holds a Bachelor of Science with Japanese from Griffith University, Queensland, Australia, majoring in Chemistry and Physics.
She has over sixteen years experience in the biotechnology field, specializing in cGMP manufacturing, protein purification and fill/finish. Her operational experience includes laboratory design and build, including the design and construction of the cGMP compliant facility for Alpha Biologics and also obtaining cGMP accreditation for a facility in the UK. Her previous working experience includes holding various positions in the biotechnology field with Xenova PLC, Xenova Limited and Agen Biomedical Limited. |
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Nick Kotlarski
Principal Consultant
Synertec Asia Pte Ltd |
Date: 29 May 2011, Sunday
Workshop 2
Topic: “Designing and Validating a PIC/S Compliant Manufacturing Facility”
Nick is a qualified Biopharmaceutical Engineer with more than 15 years of experience. He is currently Principle Consultant, Biopharmaceutical with Synertec Asia Pte Ltd in Singapore. He has also worked in the development of commercial bioprocesses through to formulation, facility design, drug production registration and leading manufacturing operations in PIC/S- and FDA-regulated organizations located in the Asia-Pacific region, Europe, and North America.
Nick has been an invited guest lecturer at a number of universities for topics on industrial biopharmaceutical manufacturing and presented at many industry meetings on the subject covering optimizing design, operation, and compliance of manufacturing facilities. Nick has a B.E. (Chem.) (Hons.) and a Ph.D. from The University of Adelaide. He has been a member of ISPE since 2003. |
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Niranjan Masurekar (Niri)
EXCO Member
Singapore Institution of Safety Officers |
Date: 30 May 2011, Monday
Track: Keynote Plenary Session
Topic: “An Overview of the Singapore Workplace Safety and Health Strategy and Its implication to the Pharmaceutical Industry”
Niri is an Operational Excellence Director / Team Leader at Pfizer Asia Pacific Pte Ltd’s Singapore Plant. He leads the Operational Excellence (OpEx) initiatives and oversees the implementation and promotion of an OpEx culture.
Niri holds a B.S. from Bangalore University, India, and is a registered Workplace Safety & Health Officer with the Singapore Ministry of Manpower. He has about 26 yrs experience in Root Cause Analysis in Environment Health & Safety related incidents and projects in the Chemical and Pharmaceutical Industry. His experience spans across countries such as the Middle East, India and Singapore in Manufacturing and Construction including off-shore. He is currently an EXCO Member of the Singapore Institute of Safety Officers (SISO) and leads the Government & International Affairs Sub-Committee. |
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Ray Collyer
Senior Consultant
SeerPharma (Singapore) Pte Ltd |
Date: 29 May 2011, Sunday
Workshop 1
Topic: “Behavioural GMP – Breaking the Fire-Fighting Cycle”
Date: 31 May 2011, Tuesday
Track: Biotechnology
Topic: “Bio-Pharmaceutical Cleaning Validation – Where to Start?”
Ray has over 26 years experience in the Pharmaceutical, Medical Device and Biological Industries in Quality Assurance, Production, Validation, Project Management, Training and Consulting. He has held senior positions in multinational pharmaceutical companies in the UK. Ray has worked in the areas of human and veterinary pharmaceutical products and in-vitro human diagnostics. Ray has been in Singapore since October 2008 and is currently a Senior Consultant with SeerPharma, a consultancy specialising in Regulatory Compliance and Quality Management. |
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Sanjay B. Shah
Director, Plant & Process Engineering Biologics Development Center
Dr. Reddy's Laboratories |
Date: 31 May 2011, Tuesday
Track: Biotechnology
Topic: "Process Engineering and Biotech Operations Excellence: Challenges And Opportunities"
Sanjay is the Director of Plant & Process Engineering function at Biologics Center of Dr. Reddys Labs in India. Sanjay has Bachelor’s and Master’s degrees in Chemical Engineering and over 14 years of experience in fields of process engineering, biopharmaceutical projects & operations.
Sanjay has been with Biologics Unit of Dr. Reddys Labs since April 2010 and is responsible for operations support, capital projects, technology transfer & initiatives, quality management systems, short & long term capacity planning. Currently, Sanjay is also supporting the start-up of new cell culture facility. Prior to joining Dr. Reddys, Sanjay worked for over 5 years with ImClone Systems, subsidiary of Eli Lilly, as Associate Director of Process Engineering department, where he supported large-scale commercial and late-stage-clinical mAb manufacturing in New Jersey, USA. Prior to that, Sanjay was the lead downstream process engineer with Amgen & Aker Kvaerner and led the Enbrel® BioNext project (Rhode Island, USA) from conceptual design stage to physical completion. Before that, he worked with Aker Kvaerner in New Jersey as a senior process engineer on large capital projects. Sanjay’s strong background in the engineering and manufacturing functions and exposure to big biopharma business provides him with unique perspective to Indian biopharmaceutical operations. |
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Sia Chong Hock
Division Director
Audit & Licensing Division & Director
Quality Assurance Office
Health Products Regulation Group
Health Sciences Authority (HSA), Singapore |
Date: 30 May 2011, Monday
Track: Regulatory
Topic: “Challenges in Inspection and Regulation of Traditional and Herbal Medicinal Products (T/HMPs)”
Mr Sia Chong Hock holds a Bachelors Degree in Pharmacy from the University of Singapore as well as a Masters Degree in Healthcare Management with distinction from the University of Wales. He has worked close to 30 years in various positions in the pharmaceutical and healthcare sectors of the Singapore Public Service – covering manufacturing and quality assurance of medicinal products, hospital and community pharmacy management, drug product quality review and Good Manufacturing Practice (GMP) inspection.
Currently, Mr Sia is the Division Director of the Audit & Licensing Division and, concurrently, the Director of the Quality Assurance Office of the Health Products Regulations Group of HSA. He is also an Adjunct Associate Professor with the National University of Singapore, where he delivers lectures at its Department of Pharmacy, Faculty of Science.
Outside of his regulatory and academic work, Mr Sia is the Chairman of the ASEAN Mutual Recognition Arrangement (MRA) Taskforce on GMP Inspection, board member of the Singapore Pharmacy Council and its Committees on Pharmacists Code of Ethics and Pre-Registration Training. |
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Syed F. Huda
Global Quality Assurance Manager
Reckitt Benckiser Ltd |
Date: 30 May 2011, Monday
Track: Regulatory
Topic: “Strategy for Success – Surviving GMP Inspection by MHRA”
The presenter is currently responsible for Quality Assurance in the Developing Markets, which includes 4 regions viz. Latin America, Africa & the Middle East, South Asia and East Asia and about 100 countries. It is a complex Supply base in this region with 20 own plants located in 15 countries, over 120 co-packers located in over 40 countries and a Team of 5,800 persons, sourcing over 60 markets.
Mr. Huda is currently working as Global Quality Assurance Manager in Reckitt Benckiser Healthcare Ltd. in Thailand. He is trained and educated in Pakistan and USA, completing his MS in Industrial Pharmacy from The University of Toledo, Ohio, USA. He has more than 20 yrs of working experience in Pharmaceutical industry from different countries.
Mr. Huda holds patents in USA and Europe on developing technique for producing slow release products. He possess diverse experience including manufacturing, QA/QC, regulatory, product development, formulation development, process & method development, process & method validation, R&D, factory administration, operations, HVAC, plant design & maintenance, and risk management and its applications. He has exposure to Quality improvement tools and has completed various KIAZEN & MUDA projects. He is an exfperienced GMP auditor and certified lead auditor for ISO 9001–2000. |
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Timothy P. Howard
Vice President
Commissioning Agents, Inc. |
Date: 31 May 2011, Tuesday
Track: Operational Excellence
Topic: “ISPE C&Q Baseline Guide – An Overview”
Topic: “Quality Risk Management Drives QbD and Process Improvements, a New Facility Case Study”
Mr. Howard is a Vice President at Commissioning Agents, Inc. and leads the regulated Commissioning and Validation services business area. He also provides Commissioning and Validation program consulting and project planning services. Mr. Howard has 16 years of pharmaceutical / biotechnology industry experience. He is the co-chair of the ISPE C&Q COP, and past chair of ISPE’s North American Education Committee. Mr. Howard was a member of the ISPE Task Team that developed the ASTM standard E2500 on science and risk base qualification and a contributing author to draft ISPE Guidance Documents on ASTM E2500 Implementation. Mr. Howard is a qualified trainer for the ISPE training course on C&Q applications, regularly speaks at conference seminars, and is published in Pharmaceutical Engineering. He is a former naval nuclear submarine officer, and was previously licensed as a senior reactor operator on a commercial nuclear power plant. Mr. Howard earned a B.S. degree in Mechanical Engineering from N.C. State University, is a Certified Pharmaceutical Industry Professional (CPIP), and a registered professional engineer in North Carolina. |
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Todd Mabe
Principal Technical Manager, Validations
Roche Singapore Technical Operations |
Date: 31 May 2011, Tuesday
Track: Operational Excellence
Topic: “3 in 1: A non conventional streamlined validation approach”
Todd Mabe is a Principal Technical Manager of Validations for 2 new Roche bulk API (E-coli and CHO) facilities in Singapore. He is the Quality Lead for all Quality, Engineering & Validation efforts. These include commissioning, computer systems, utilities, facilities, equipment, QC methods, technology transfers, cleaning and process validation. He supports all regulatory expectations for licensure. Additionally, He manages the Singapore Risk Management activities.
His past experiences in the Biotech and the Pharmaceutical industry include QC release testing, Quality Management, Validation Manager and was a quality consultant for multinational companies. He has experience in establishment and maintaining Quality systems for validation, document management, change control, discrepancy management, training, validation document strategic development, execution and approval; analytical method validation; engineering of pharma and biotech facilities. His efforts helped Roche Singapore receive the 2010 “Facility of the Year Award”. |