GMP & Engineering Forum 2018
Managing Director, PharmOut
PharmOut’s founder with a passion for innovation, continuous improvement and manufacturing, Trevor has held a variety of roles within the automotive, pharmaceutical, food and chemical industries. His vision is to provide industry with practical, cost-effective solutions and help to improve manufacturing practices throughout Australia.
Bob is a life-long learner who stays engaged in new technology and organizational trends in order to adapt them to solving operating issues across the process industries. He works with a wide variety of organizations within the Life Sciences market identifying operational problems, evaluating how to make improvements, and then justifying the best approach. Bob loves seeing the successful deployment of a solution and then sharing the benefits so that others can take advantage of the approach. Bob gets special gratification from seeing how those improvements help manufacturing improve people’s lives.
Bob is responsible for planning & delivering on Emerson’s Life Sciences Business and Operational strategy globally, working collaboratively across all facets of the Emerson portfolio.
Bob has a BS in Chemical Engineering from Rose Hulman Institute of Technology and an MBA from the University of Texas.
Charles has over 15 years’ experience in the manufacture of sterile pharmaceutical products. He has worked as a project manager at CSL both in Melbourne and Switzerland where he managed the development of a novel aseptic manufacturing process. Following his work at CSL, Charles worked as a GMP consultant specialising in sterile facility design, commissioning and validation before taking on the role as General Manager of a Contract Manufacturing Organisation. Charles brings considerable experience in all facets of facility operations and Good Manufacturing Practice.
Head of Sales and Consulting ANZ, Swisslog
Training Services Manager, PharmOut
Maria Mylonas, Lead Consultant – Training Services Manager, Maria has over 20 years’ experience in Quality Control, Quality Assurance and Learning & Development management roles in the Pharmaceutical, Medical device and Automotive industries in the Asia Pacific Region. She is a qualified Biological Scientist and educator and routinely trains industry in a wide range of GMP topics including current PIC/S updates, Data Integrity, Quality Risk Management, CAPA, ISO 13485 just to name a few. Maria is passionate about program design and competency assessments that align to business strategy and quality culture.
Bass Masri is the principal consultant at Statistical Techniques < www.statisticaltechniques.com.au>, a consulting business providing professional advice and specialising in quality analysis and strategic research. Bass has over ten years quality assurance experience in the highly regulated medical device industry and over five years of experience in project management and portfolio reporting in the public service.
Tertiary qualifications include a Bachelor of Science and a Master of Statistics from Macquarie University along with professional certificates in Advanced Data Analytics, Lean Six Sigma and PRINCE2 Project Management.
Bass has a strong passion for the statistical techniques most commonly used in the social sciences, process improvement, manufacturing engineering and research and development. Bass has a long-standing relationship with Minitab, first using Minitab in 1995 at Macquarie University and more recently, as Principal Statistician with ResMed, the leader in sleep and respiratory medicine. Bass is also part of Minitab’s Consultant Support Program.
Varkey Joseph Vettoor
Varkey has been working in GMP environments for around 8 years and has worked in a variety of technical and quality roles, including validation, compliance, QA and production.
Working with QikSolve since it’s launch in 2014, Matt has a background in Business Analytics and with a focus on process design and improvement. Working at QikSolve he has been setting the strategic direction and leading the product development of the company. He brings a highly consultative approach in developing new ideas and workflows.
Lead Consultant, PharmOut
Tanja is a qualified Microbiologist with extensive experience in the pharmaceutical manufacturing of sterile injectable and non-sterile drugs encompassing:
- Quality management
- Routine microbiological testing
- GLP and GMP compliance
Mark is an experienced Director of Quality Assurance with a demonstrated history of working in the pharmaceutical industry. Strong quality assurance professional skilled in Data Integrity, Good Manufacturing Practice (GMP), Inspection management, Quality Improvement, investigations and Change Control.
Stoyan is a Senior QA Compliance Associate at CSL Behring Melbourne. Prior joining CSL Behring, he was a Team Leader at TGA MQB (GMP Clearance Assessments).
Stoyan has over 16 years of experience in the Pharmaceutical and Biotech industries. He has worked for European and Australian manufacturers (sterile and non-sterile dosage forms) and has experience in Manufacturing, Validation, Regulatory Compliance and Quality. He has held various leadership roles in Validation, Regulatory Compliance and Quality Assurance in EMA, TGA and FDA regulated entities.
Stoyan holds a Master of Chemical Engineering degree (University of Technology Burgas) and a Master of Medical Science in Drug Development degree (University of New South Wales).
Production Manager, Grunbiotics
Keith is the Production Manager at Grunbiotics which is a start-up company manufacturing Food for Special Medical Purposes.
I am a passionate professional who has worked for companies such as Novartis, Mayne Pharma (Pfizer), Catalent and Leica Biosystems with cross functional experience in Quality, Production and Supply Chain roles. I have also worked with different presentations including API’s, Sterile Parenterals, Softgel and Hardshell Capsules, Tablets and Medical Devices in many regulated environments including TGA, FDA, EMA, HSA and PMDA.
David possesses 30 years experience in the pharmaceutical industry and is currently the General Manager at Quest Pharmaceuticals, a contract manufacturer of listed therapeutics. Prior to joining Quest in 2015, Mr. Doolan has worked in a variety of roles for both global pharmaceutical and Nutritional Medicine companies, with extensive experience overseeing Production, Quality, Technical, NPD, and several other processes in the production and distribution of pharmaceutical and nutraceutical
Validation Services Manager, PharmOut
Ashley offers over 20 years’ experience as a qualified Chemical Engineer in GMP-regulated industries, including pharmaceuticals, pharmacies, medical devices and blood & tissue organisations. His expertise includes validation, process engineering and GMP compliance, GDP, with specialties in sterile manufacture, HVAC systems and cleanroom design and construction.
Ashley has trained regulatory agencies as well as supported start-up companies to find their way through CFR 820, CFR Part 11, PIC/s and ISO 13485. Ashley routinely conducts practical gap analysis and inspections to assist companies develop compliance road maps and support vendor audits
Wayne is a tertiary qualified Medical / Pharmaceutical Microbiologist and has over 40 years of experience in the Pharmaceutical Industry in the areas of Quality Management, Sterile Product Manufacturing, Technical Training, cGMP Auditing, Validation & Process Improvement.
He has held senior positions in Sales & Marketing which have enabled him to develop knowledge & skills in areas of business Management complementary to his technical experience.
Wayne is a Qualified Quality Auditor with Certificate 4 (Category 2), in Workplace Training. He has developed a sound knowledge of all aspects of the Code of Good Manufacturing Practice. He is a skilled practitioner in Contamination Control, and as a result has worked on a number of projects, here and overseas (Germany, China, Bangladesh , Indonesia &Thailand) in both corrective & preventative situations.
Wayne has also worked for the WHO in Iran.
Wayne is Managing Director for Waytotrain Pty Ltd, a company specializing in Corporate Training & Consultancy. The Company provides a broad range of Business, Management Technical Training & Consulting Services to companies and organizations in both the public and private sectors.
In 2007 Wayne & his business partner established a Microbial genomics business (MICROGENETIX P/L) performing target PCR and DNA sequencing services to the Pharmaceutical & Food industries. The company is now Australia’s leading provider of Genomic Microbial identification Services.
Since joining the Microgenetix team, Tara has been instrumental in the method development and implementation of the Next Generation Sequencing service. Including the investigation and understanding of:
- Matrix specific DNA technology incorporating each specific QIAgen extraction methodology (automated on the QIAcube (Qiagen)).
- The use of environmental specific primers for amplification of the 16S gene.
- The implementation of library preparation methodology for sequencing on the Illumina Miseq system.
- The investigation of various analysis pipelines for the most useful data interpretation.
The implementation and interpretation of mock communities to ensure validity of results.
Eoin has worked for over 13 years in the pharmaceutical and biotech industries on products including APIs, small molecular products, blockbuster recombinant proteins and IV solutions. He has experience in the areas of development, quality control, quality assurance, validation, engineering, regulatory affairs and lean manufacturing. Eoin has strong knowledge of GMP/QMS systems and regulatory compliance in US, EMA and TGA regions.
Member of the extended management team Jason is responsible for the Product Management and Marketing function for SICK across Australia and New Zealand. Having commenced his working life in the manufacturing industry.
Jason has gained over 25 years experience across a number of disciplines including Technical, Product Management, Sales and Marketing. He understands the challenges the manufacturing sector face in a global market space having spent over 10 years in manufacturing improving productivity and safety through the introduction of advanced technical automation.
He is a current member of the SF041 Safety committee for Standards Australia developing the AS/NZ 4024 safety series of standards for the Australian and New Zealand markets. He also supports industry through providing machine guard safety training and is an active member of the National Safety Council of Australia.
Experienced Consultant with a demonstrated history of working in the pharmaceuticals and Life Science Industry. Skilled in Negotiation, Pharmaceutics, Sales, Medical Devices, and Sales Operations.
Keith has over 30 Years’ experience within the Pharmaceutical, Medical Device and associated Cleanroom/Sterile Facility space, predominantly within the Consumable and specialist Services market.
He is responsible for all Sales and Marketing activities throughout Australia and New Zealand.
Michael graduated from the University of New South Wales in Sydney Australia with a degree in Chemical Engineering specializing in Bioprocess Technology. For the past 38 years at Merck (Millipore) he has been in a variety of positions in Australia, Asia and the USA including ten years in Bedford USA as Manager of Worldwide Technical Training, and ten years as Asian Validation & Technical Support Manager. He is now the Senior Biosafety Technical Consultant in Merck Asia supporting both regulatory authorities and pharmaceutical companies in areas of compliance and best practices in sterile processing.
Michael has audited and reviewed a large number of local and multinational companies over the past 18 years focusing on regulatory compliant and effective filtration practices. He has presented in a variety of PDA and industry conferences on areas of integrity testing, good filtration practices, compliance and validation.
Lucas Bogtstra is the General Manager and Head of Solutions Business for Testo Australia. He leads a team of professionals and through them coordinates activities to provide clientele with solutions specifically tailored to their environment to enhance outcomes be that in product quality, risk mitigation, compliance, customer satisfaction and importantly providing a return on investment impacting on the profitability for the organisation.
Lucas with his team has worked with many large organisations in the Health and Pharma Industries and is privileged to be working for a solely owned subsidiary of the manufacturer Testo Germany for over 13 years.
Lucas has spearheaded specialized projects with organisations such as Bio 21, The University of Melb, The Alfred Hospital, Baxter Laboratories, Virtus Health, Jurlique, Central Health Services, GSK, BMS and Monash IVF Group amongst others.
Having worked collaboratively with these organizations Lucas and his team have managed to address critical pain points specific to each operation.
Ryan is the National Segment Manager hygienic. The role of Hygienic Processing covers the market for Pharmaceuticals, Biotechnology, Food & Beverage. Within each of these industries it is the Segment Managers responsibility to understand, communicate and engineer typical automation & control solutions for applications in these industries such as CIP/SIP, Control Networks, Clean Utilities, Fermentation, Plant Utilities, Sterilization and any other typical automation & control type applications.
Nic van der Nol
Executive Architect, PharmOut
Nic is a registered architect and building practitioner. Nic has over 15 years’ experience in the detail design, documentation and contract administration of a large range of pharmaceutical, hospital and sterile manufacturing facilities, both locally and internationally.
Barry has a unique mix of technical skill and international business experience with a strong focus on bringing new technologies to market. A track record of applying skills to a range of markets and technologies. Proven delivery in all aspects of product development from needs analysis, strategy and solution concepts through to development, marketing and sales.
Experience has ranged from small to large private Australian companies (ANCA) through to the bluest of blue-chip multinationals (Kodak), working in local, Asia regional and international roles, including time living in the USA.
Product Manager, DCS, Siemens
Experienced and successful Product Manager with a demonstrated history of working in Plant Automation field for Process and Manufacturing industries; in particular in Water & Waste Water, Chemical and Pharmaceutical industry domains. Currently specialising in Process Control, Process Safety, Control Systems Design, with previous experience in SCADA, PLC and HMIs.
PhD and Masters in Architecture and Masters in Science with 20 years work experience, with key expertise is the strategic application of technology for the design, delivery and operation of built assets.
He consults, researches and publishes about the use of technology in Design, Construction Management, and Facilities/Asset Management and teaches as a Senior Lecturer in Digital Architectural Design at Melbourne University, Australia.
Specialties: Building Information Modelling, BIM to FM, Organisational Change Management, Collaborative Design, Advanced Geometry, Parametric Design, Building Performance Analysis, Optioneering