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Ray Collyer
Senior Consultant
SeerPharma Singapore
Singapore |
Presentation: "API Manufacture and Cost Effective Compliance"
Date: 7 June 2010
Track: API
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 Oct 2008 and is currently working for SeerPharma, a consultancy firm specialising in Compliance. |
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Martin R Dyxenburg
Senior Production Manager
Novo Nordisk A/S
People's Republic of China |
Presentation: "The basics of Aseptic Processing, and trends in Aseptic techniques"
Date: 8 June 2010
Track: Secondary Pharma Mfg
Martin R Dyxenburg is currently Senior Production Manager in Novo Nordisk A/S, for the Insulin Filling plant in Tianjin, China. He has more than 15 years of pharmaceutical manufacturing experience in the areas of aseptic sterile manufacturing and from packaging. He has experience from production and quality departments, in the processes of API, semi-finished and finished products. Lately he has been assigned to the construction of Novo Nordisk A/S facilities for insulin filling in China, based on his experience from facilities in operation. |
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Jan-Willem Eleveld
Vice President, Consulting & Services, Asia Pacific
IMS Health
Singapore |
Presentation: Industry Overview Keynote
Date: 7 June 2010
Plenary Keynotes Session
Jan-Willem Eleveld is Vice President for Asia Pacific at IMS Consulting & Services based out of Singapore. He has 16 years of extensive experience in the pharmaceutical industry in Asia Pacific, USA and Europe. As a strategy consultant Jan-Willem has assisted many International, Regional and Local companies and other institutions with advise, focusing in particular on growth strategies, market entry, new commercial models and licensing/M&A assignments as well as organizational and market access projects in emerging markets. |
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Gordon Farquharson
Managing Director
Critical Systems Ltd
United Kingdom |
Workshop 2: Environmental Control & HVAC - Is sustainability and GMP compliance compatible?
Date: 6 June 2010
Presentation: "Achieving effective containment facilities - primary and secondary containment for chemical & bio-safety applications”
Date: 7 June 2010
Track: Innovation - Day 1
Gordon is a chartered consulting engineer with more than 30 years experience of quality & safety critical processes and facilities used by industries such as healthcare, life science, etc. He has focused on technologies such as isolators, barrier technology, mini-environments, and critical utility systems. More recently he has been working in the area of sustainability, from an energy and resource perspective, as well as in a broader business sense. He has been involved in the development of new regulatory standards, e.g. CEN/ISO cleanroom and contamination control standards, WHO GMP guidance and ISPE Baseline® Guides. He has recently worked with the EMEA in London to help update and improve the cleanroom classification and monitoring requirements in Annex 1 of the EU and PIC/S GMPs. Gordon is Managing Director at Critical Systems Ltd www.critical-systems.co.uk , and Senior Consultant with PharmOut Pty Ltd www.pharmout.com.au |
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 Darren Freestone
Senior Consultant
SeerPharma
Australia
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Presentation: “Proactive Strategies for Managing Your Distribution Network”
Date: 8 June 2010
Track: Supply Chain
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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 Dan Hagewiesche
Director of Manufacturing
Roche Singapore Technical
Operations
Singapore
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Presentation: “Multi-Product Strategies in a Biologics Facility”
Date: 8 June 2010
Track: Biologics
Dan Hagewiesche is the Director of Manufacturing at Roche Singapore Technical Operations. He has over 20 years experience in Manufacturing, Technical Support, and Process Research & Development. He previously headed clinical production, and managed the Manufacturing Science and Technology Department in Roche’s facilities in USA. Dan has led numerous Biologics technology transfers and participated in several plant startups. |
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Jenny Hantzinikolas
GMP Auditor
Therapeutic Goods Administration
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Presentation: “Aseptic and Sterile Manufacture - Regulatory Challenges”
Date: 7 June 2010
Track: Regulatory
Jenny has been employed as a GMP auditor with the TGA since 2004. In this time she has conducted audits of a broad range of manufacturers of therapeutic goods including Sterile and Non-sterile Medicines, Biologicals, Active Pharmaceutical Ingredients both in Australia and internationally.
Jenny has a Science degree (Majoring in Biochemistry and Microbiology) and also has a Master's degree in Engineering (Majoring in Quality Management and Technology). She has extensive experience in working in GMP environments including bacterial and viral vaccine manufacturing including veterinary medicines manufacturing.
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Dr. Kowid Ho
Biologicals/Biotechnology Unit
AFSSaPS |
Presentation: EMA Regulatory Keynote: “A regulator's perspective on ‘Quality by Design’ - Application & Perspectives for Biologicals”
Date: 7 June 2010
Plenary Kenotes Session
Presentation: “European regulatory guidelines for similar biological medicinal products”
Date: 7 June 2010
Track: Regulatory
Kowid Ho has been reviewing the quality of biological medicinal products at AFSSaPS (Agence Française de Sécurité Sanitaire des Produits de Santé) for the last 10 years. He has authored many assessment reports and scientific advices, and regularly participates to European Medicines Agency (EMA) Biologics Working Party (BWP), Biosimilar Working Party (BMWP), PAT team and other BWP ad'hoc groups.
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 Bassel Iskandarani
Director of Pharmaceutical Technology
MSD Singapore
Singapore
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Presentation: "Design considerations for Optimal Cleanability in API Equipment"
Date: 7 June 2010
Track: API
Bassel Iskandarani is Director of Pharmaceutical Technology at MSD, Singapore. He has over eighteen years of experience in the pharmaceutical industry in the areas of product development, manufacturing, and quality engineering. His current responsibilities include technology transfer of new products, process improvement, process validation, and facility design and qualification. |
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 Dr. L. Praveen Kumar
Director of Quality Assurance & Regulatory Affairs
Alpha Biologics Sdn Bhd
Malaysia
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Presentation: “Quality Management in Biologics Manufacturing”
Date: 8 June 2010
Track: Biologics
Dr. L. Praveen Kumar is Director of Quality Assurance and Regulatory Affairs at Alpha Biologics. He is responsible for overall administration of the Quality Unit which comprises of QA, QC and Regulatory functions and is currently responsible for developing and implementing Quality Management systems complying with USFDA, EMEA and Malaysian FDA (NPCB) standards. Dr. Praveen has 10+ years of professional & academic experience in the areas of research, quality assurance and regulatory compliance of biopharmaceuticals and related areas.
Prior to joining Alpha Biologics in 2008, he has worked in Biotech & Biopharma industry in India. He has undergone extensive training in International Drug Regulatory Affairs, Biosafety and Regulatory Policies, Good Laboratory Practices and other related topics. |
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Con Leddy
Associate Director
PM Group
Ireland |
Presentation: ISPE Facility of the Year Award 2009 (Sustainability) – Centocor Case Study
Date: 7 June 2010
Track: Innovation - Day 1
Con Leddy is an Associate Director and leader of PM Group’s Sustainable Energy Engineering team. He has 20 years experience in the design of mechanical services for the biopharmaceutical, electronics and medical technology sectors in Ireland and internationally. Most recently he was project leader of the SEI EED Special Working Group to develop an Energy Efficient Design Methodology guideline. Con was a key part of the design team involved in the Centocor Biologics Ireland facility which won the ISPE facility of the year award for sustainable design solutions. |
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Michel Lok
Head, Office of Manufacturing Quality
Therapeutic Goods Administration
Australia |
Presentation: “Effective Regulation through International Cooperation”
Date: 7 June 2010
Plenary Keynotes Session
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 and has held a number of Senior Executive positions within the Health 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; establishing health infrastructure in rural and remote 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. |
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 Todd Mabe
Principal Technical Manager, Validations
Roche Singapore Technical
Operations
Singapore
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Presentation: “Validation Strategies for a Fast track API Facility”
Date: 8 June 2010
Track: Validation
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.
Prior to his new assignment, he was a Validation Quality Manager in Corporate Quality Systems & Support for Genentech supporting the development and establishment of Validation policies/standards and Quality System process improvements. He revised the Genentech validation quality policy. He has been involved in process validation efforts (licensure of Lucentis and Rituxan v1.2), Quality Policy revisions and quality approval of Genentech validation documents.
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. |
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 John Machulski
Senior Project Director
Lonza Biologics Singapore
Singapore
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Presentation: “The Advantages of Leveraging Manufacturing Plant Designs Globally”
Date: 8 June 2010
Track: Biologics
John Machulski is currently Senior Project Director at Lonza Biologics Singapore Pte Ltd. Lonza is a Swiss based custom manufacturing company which specializes in contract development and manufacturing services for the pharmaceutical and biotech industries. In this role, John has engineering, construction and startup responsibility for Lonza’s US$600M capital investment program for their two planned biopharmaceutical production facilities at Tuas. John has been with Lonza for 10 years and served in several capital project and operational functions in their US business prior to coming to Singapore in 2007.
Prior to joining Lonza, John was with Wyeth Pharmaceuticals and Johnson & Johnson in a variety of engineering and operations roles in the US and Puerto Rico. John holds a BS in Mechanical Engineering from Lehigh University and an MBA from LaSalle University, both in the United States. |
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William McNamara
Project Manager
Bovis Lend Lease Pharmaceutical
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Presentation: ISPE Facility of the Year Award 2010 for Project Execution (Genentech Singapore facility) – A case study
Date: 8 June 2010
Track: Innovation - Day 2
William McNamara is a Project Manager with Bovis Lend Lease Pharmaceutical Singapore.
His Singapore Projects include Schering Plough Biotech in 2001 / 2002 where he was Commissioning Manager and the recently completed Genentech E-Coli Modular Fermentation Facility, which has been awarded the 2010 ISPE Facility of the Year for Project Execution and BCA Green Mark Gold Certification.
William is currently Project Manager for the Design, Construction and Commissioning of the new Alcon Singapore Facility Ophthalmic Manufacturing Facility in Tuas, Singapore. He has over 20 years experience in the design and execution of Pharma, Industrial and Commercial Projects and has worked in South Africa, Ireland and the U.K. |
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Bryan McSwiney
Director Asia & Middle East
Zenith Technologies Ltd.
Singapore |
Presentation: “The Role of Automation in Global Pharmaceutical anti-counterfeiting”
Date: 8 June 2010
Track: Automation
Bryan possesses more than 15 years experience in the global life sciences sector, having successfully managed technology deployment & roll-out in the areas of automation, process control & MES applications for many major pharma, biotech & vaccine companies globally. With current responsibilities for Asia & Middle East, Bryan also chairs a Zenith Technologies steering group looking at the utilization & application of technology to combat the growing counterfeiting risk in the pharmaceutical industry. |
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 Gaurav Mehta
Principal Project Automation Engr
Alcon Manufacturing Singapore
Singapore
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Presentation: “Automation for Aseptic Manufacturing”
Date: 8 June 2010
Track: Secondary Pharma Mfg
Gaurav Mehta is the Principal Project Automation Engineer of Alcon, Inc., the world’s largest eye care company. Mr. Mehta currently heads the automation design and team for the new Singapore plant.
Mr. Mehta started his career with Alcon, Inc. in March, 2005 as an Automation Engineer for Alcon’s Fort Worth (headquarter) Manufacturing Facility where he grew to hold the positions of Senior Automation Engineer and then Principal Project Automation Engineer. In Fort Worth, Mr. Mehta had successfully carried out schedule and budget driven large size automation projects such as a brand new aseptic compounding and fill line; prototype integrated Pulsed UV system.
Mr. Mehta is part of the pioneer team developing Alcon’s first Asian Pharmaceutical Manufacturing plant in Tuas, Singapore. Although Alcon has various manufacturing facilities around the globe, this plant will be the company’s first to be built from the ground up outside of the United States.
Prior to joining Alcon, Mr. Mehta carried out Project Engineering and Management roles after starting as a Field Engineer with Rockwell Automation. With Rockwell, Mr. Mehta worked on a wide rage of applications such as Biotechnology, Pharmaceutical, Food, Automotive, Paper, Metal, Cement, etc. Prior to being employed with Rockwell, Mr. Mehta was employed with Johnson and Johnson in an Engineering role.
Mr. Mehta holds a Bachelor of Science degree from Boston University, Massachusetts, USA with concentration in Biomedical and Electrical Engineering. |
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Mohammad Nazrin Abdul Samat
Senior Chemical Engineer
Technical Development
GlaxoSmithKline
Singapore |
Presentation: “Application of NIR as real time monitoring tool in API manufacturing”
Date: 7 June 2010
Track: API
Nazrin is a senior chemical engineer with GSK Jurong’s Technical Development for almost 9 years. His responsibility includes developing/implementing Process Analytical Technology and other technology solutions in support of new chemical entities (NCE) introduction, leading NCE technical transfers of NCEs projects, leading/supporting process improvement and sustainable manufacturing initiatives.
Prior to joining GSK he had 5 years of industrial experience working in the petrochemical (MTBE production) and steel industries as production engineer and environmental engineer respectively. He holds B.E. from University of New South Wales, Sydney and MSc from the National University of Singapore. |
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 Bart Moors
Senior Business and Project Manager
Pharmaceutical Industry SEA
Siemens AG
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Presentation: “PAT, the enabler for continuous manufacturing processes - An innovative way of developing and producing drugs”
Date: 8 June 2010
Track: Automation
Bart 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 built 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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 Michael Pelletier
Associate Director of Engineering
Lonza Biologics Singapore
Singapore
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Presentation: “Implementation of an Electronic Batch Record system in a Biologics Production Facility”
Date: 8 June 2010
Track: Automation
Michael Pelletier is Associate Director of Engineering at the Lonza Biologics production facility in Singapore. He has worked in the Biotechnology and Medical Device industries for seventeen years including seven years at Abbott Laboratories as a Research Scientist and Program Manager in their Glucose Products group.
Michael joined Lonza in 2002 as the Automation Project Manager for the Large Scale Build Out project in Portsmouth NH USA, and was later Manager of the Controls and Calibration groups at the site. He is currently responsible for Automation Development and Plant Commissioning activities at the Lonza Biologics Singapore expansion project.
Michael holds a BS in Chemical Engineering from the University of New Hampshire and an MBA from Northeastern University. |
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Dr. Alice Redmond
CQ Technical Director
PM Group
Ireland |
Presentation: ISPE Article of the Year 2009: “The FDA’s Draft Process Validation Guidance – A Perspective from Industry”
Date: 8 June 2010
Track: Validation
Alice Redmond is CQ Technical Director with PM Group, has over 20 years experience in R&D, Pharmaceutical (API, Formulation Fill, Solid dosage) and Biotechnology industry. Alice graduated with a BSc in Biotechnology in 1987, PhD in Biotechnology in 1991 and a MBs in 2001.
Current responsibilities include oversight of regulatory compliance, GEP, quality, commissioning, qualification and validation strategies on a corporate level for PM Group. Alice has led number C&Q projects for numerous multinational clients on a global basis and is currently actively working on Consultancy assignments including ASTM E2500-07 implementation, Technology transfer, process validation, lean C&Q and practical risk assessment strategies. Alice is an active member of the ISPE and PDA, and was recent award winner of 2009 ISPE Article of the Year titled “An industry perspective on the Draft Process Validation guide”.
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 Anuj Sharda
Production Manager
Biotechnology Plant
MSD Singapore
Singapore
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Presentation: “Use of RABS in Sterile Manufacturing”
Date: 8 June 2010
Track: Secondary Pharma Mfg
Anuj Sharda joined Schering-Plough LTD (now MSD Singapore) in 2001 and currently is the Production Manager of Sterile Fill finish plant producing biologically derived products. Anuj was one of the pioneer members of the team involved in setting up the Biotech plant. He was actively involved in setting up the systems in the plant including establishing RABS on line 1 and responsible for designing, retrofitting RABS on line 2.
Prior to Schering-Plough LTD, Anuj had more than 7 years of sterile manufacturing experience mainly in filling Liquid Ampoule and Dry powder vial in GlaxoSmithKline Pharmaceutical manufacturing facility in India. |
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 Dr. Paul Sharratt
Programme Manager
Process Science & Modelling
ICES
Singapore
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Presentation: “Green Pharmaceutical Manufacturing”
Date: 8 June 2010
Track: Innovation - Day 2
Paul Sharratt has been the Programme Manager for Process Science and Modelling at the Institute of Chemical and Engineering Sciences in Singapore since 2008. Following a first degree in Cambridge, Paul was awarded a PhD for work in catalytic reaction engineering (1987) from the University of Manchester. He then spent 4 years working for Imperial Chemical Industries as a process engineer, gaining experience in research, development, design and operation in manufacture of agrochemicals and other low tonnage (batch) products. He returned to UMIST (now the University of Manchester) in 1991 and was promoted to a full Chair in 2001. He was awarded a Royal Academy of Engineering / EPSRC Chair in Innovative Manufacturing for the period 2001-6 and until 2008 he was Professor of Sustainable Processing in the School of Chemical Engineering and Analytical Science (SCEAS) in the University of Manchester.
His research is in chemical, pharmaceutical process development and design, sustainable development and reaction engineering. He has active collaborations with many pharmaceutical and other process companies. He has more than 40 published refereed journal articles, books and book chapters, as well as over 100 conference publications. He is a director of BRITEST Limited – a not-for-profit company that supports innovation in chemicals and pharmaceuticals manufacture.
He also holds an honorary chair in the Universidad Major de San Marcos in Lima, and is a fellow of the Institution of Chemical Engineers. |
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 Sia Chong Hock
Director, Manufacturing and Quality Audit Division
Health Products Regulation Group
Health Sciences Authority
Singapore
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Presentation: "Towards A Quality Assurance System for Drug Regulatory Authorities"
Date: 7 June 2010
Track: Regulatory
Mr. Sia Chong Hock holds a Bachelors degree in Pharmacy from the University of Singapore as well as a Masters degree in Healthcare Management from the University of Wales. He has worked more than 25 years in various positions in the pharmaceutical and healthcare sectors – covering manufacturing and quality assurance, drug procurement, hospital and community pharmacy, total parenteral nutrition (TPN) production, regulatory control of psychotropic substances and narcotic drugs, adverse drug reaction (ADR) monitoring, drug product quality review and facility inspection.
Currently, he is the Director of the Division of Manufacturing and Quality Audit of the Singapore Health Sciences Authority (HSA), as well as an Adjunct Assistant Professor with the Department of Pharmacy of the National University of Singapore (NUS), where he delivers some lectures in industrial pharmacy and local pharmaceutical regulations. He is also the Chairman of the ASEAN Mutual Recognition Arrangement (MRA) Taskforce on GMP Inspection, the Secretary of HSA Quality Control Advisory Committee, a board member of the Singapore Pharmacy Council and a member of the SPRING Singapore Good Laboratory Practice (GLP) Advisory Committee.
On the regional and international front, Mr. Sia has represented Singapore and HSA in various official capacities - as a regulatory member of the negotiation team for the Singapore-Australia MRA and Singapore-Japan MRA on GMP inspection, as a Quality System Assessor and Technical Expert in the EC-ASEAN GMP Expert Team, as a delegation member of selected PIC/S Joint Assessment and Re-assessment teams, and as an invited speaker for many local and international conferences, seminars and workshops, particularly in the field of Good Manufacturing Practice, Quality Systems and Quality Assurance of medicinal and health products. |
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Steve Slater
Vice President, Asia Operations
PSC Pte Ltd
Singapore |
Presentation: Welcome Message
Date: 7 June 2010
Plenary Keynotes Session
Steve Slater has more than 25 years of experience in the pharmaceutical and consulting industries. Steve is highly experienced in assisting companies meet international GMP standards. He has been responsible for improving compliance standards for companies throughout Europe, South East Asia, India and China. His expertise in conceptual and detailed design of Biotechnology/Pharmaceutical plants and proven ability to integrate the regulatory requirements within the design and construction phases has enabled facilitated companies entry into new markets. His skills are the result of experience in managing numerous pharmaceutical projects. This extensive project experience is key to ensuring project deliverables are practical, achievable and meet regulatory expectations. Steve has carried out audits on behalf of WHO, UNICEF and other transnational organisations. He currently heads up the Asian region for Pharmaceutical Services Corporation. PSC provides Conceptual Design, Regulatory Compliance and Validation services |
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Tony Uhe
Senior Director Quality
External Manufacturing Asia Pacific
Global Pharmaceutical Supply Chain
Johnson & Johnson |
Presentation: “Ensuring Quality in the Supply Chain”
Date: 8 June 2010
Track: Supply Chain
Tony has extensive experience in Quality Assurance in various roles in several companies including J&J and GSK.
A graduate of Deakin University (MSc) and University of Melbourne (BSc Honours), Tony has over twenty years of pharmaceutical experience. His previous pharmaceutical roles included Head of Quality API site, Head of Quality R&D QA site, Analytical service manager and IT project manager.
He is currently responsible for External Manufacturing Quality at GPSG J&Js pharmaceutical supply chain, overseeing 40 external manufacturers across the Asia Pacific region.
Tony has been a member of ISPE since 1992 and active in the Singapore affiliate since 2007.
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Brenda Uratani, Ph.D.
Assistant Country Director
U.S. FDA
China |
Presentation: “Ensuring Drug Quality for Public Health: The Implementation”
Date: 7 June 2010
Plenary Keynotes Session
Presentation: “Securing the pharmaceutical supply chain: U.S. FDA’s efforts and perspectives”
Date: 8 June 2010
Track: Supply Chain
Brenda Uratani serves as Assistant Country Director for FDA’s China Office, and holds responsibility as FDA’s primary senior technical expert on issues related to drugs and pharmaceuticals.
Before joining FDA’s China Office, Dr. Uratani served as the Senior Compliance Officer in the Office of Compliance within FDA’s Center for Drug Evaluation and Research (CDER). Before her time with FDA, Dr. Uratani worked as a research scientist for a number of years in the field of molecular genetics and biotechnology, at the U.S. National Institutes of Health, and later at a biotech firm.
Dr. Uratani has extensive working experience in Chemistry, Manufacturing, and Control review, and current Good Manufacturing Practice and compliance. She is the CDER’s sterile drug and biotech drug expert. She plays a major role in the writing of a FDA drug GMP regulation on radiopharmaceutical drugs as well as several guidances on drug manufacturing. During her time with FDA/CDER, she was active in outreach, and represented FDA frequently in industry training. She received her Ph.D. degree from Brown University. |
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 David Vincent
CEO
Validation Technologies, Inc.
United States
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Workshop 1: Effective Cleaning Validation Programme for Biologics Facility
Date: 6 June 2010
Presentation: “Current Industry and Regulatory Requirements for Biological Process Validation”
Date: 8 June 2010
Track: Validation
Mr. Vincent has over twenty-five (25) years’ experience in the life science industry specializing in the Pharmaceutical, Biotechnology, and Biopharmaceutical and Medical Device industries. He has over (19) nineteen years dedicated to the field of quality systems and validation. He has expertise in many areas of Regulatory Affairs, Quality Assurance and Validation Engineering including; regulatory submission preparation, Design Review, Construction Qualification, Project Management, Utility and Process Equipment Qualification implementation. He is especially strong in the areas of Process Development and Validation as well as developing and implementing Environmental Monitoring and Cleaning Validation Programs. He has a under graduate degree in Industrial Microbiology and a B.Sc. degree in Mechanical Engineering degree.
Mr. Vincent has spent the last seventeen (17) years providing validation and quality consultant services to various companies. During this time, Mr. Vincent has provided both project management and project execution for numerous clients national and international. He is responsible for managing and supporting many different product launches and licensing. He teaches at San Diego State University (SDSU) for their Masters of Regulatory Affairs Degree program in the Field of Validation Technology RA-776. |
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Simon White
Sales Director
PSC Pte Ltd
Singapore |
Presentation: “Containment – Is an isolator just an expensive box?”
Date: 8 June 2010
Track: Innovation -Day 2
Simon is a qualified mechanical engineer who began working with PSC Asia at the start of 2010. He has over 10years experience in the pharmaceutical industry, having previously worked in research and development, field service and commissioning, project management and then more recently in sales. Simon has been responsible for sales of both process and containment equipment, where he quickly built up a detailed understanding of contained processing, retrofitting of containment solutions and up and down stream components. This has led him to his current role as Sales Director with PSC Asia, focusing on equipment sales in the Asian markets.
Prior to relocating from the UK to Singapore in 2009, Simon was an ISPE Committee member where he worked closely with academia, manufacturers and other equipment suppliers to promote industry development and knowledge sharing.
Simon is married, with no children yet, and enjoys getting outdoors when he can. He is usually found playing football, golf, running, cycling or walking his dog around the parks of Singapore. |