Steve has over 40 years experience in the Biotechnology, Pharmaceutical and Medical Device industries in Quality Systems, Compliance and Manufacturing, including 25+ years consulting in GxP Quality Management and Regulatory Compliance.
Steve conducts FDA and EU/TGA/PICs compliance audits and gap analyses, assists companies with remediation programs and prepares companies for regulatory inspection. He has developed multiple training courses in PQS, GMP, GLP, Process Validation, Risk Management, Sterile Manufacture and Medical Device Quality Systems. He specializes in sterile products, risk management and compliance training solutions for the Life Sciences Industry.
Steve is 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. He is a past member of International Board of Directors for ISPE.
Jeff has more than 30 years experience in the biopharmaceutical industry. He has 8 years of general management experience with CSL with oversight on the manufacture and supply of plasma products, influenza vaccines, anti-venoms and diagnostic products, and the in-licensing of pharmaceuticals and vaccines.
From 2000 to 2005 Jeff was Global Head of Plasma Products Research and Development responsible for R&D strategy and programs conducted in Switzerland, Australia, the USA and Japan. Prior to this his roles included Director of Clinical and Regulatory Affairs-plasma products (1997-2000) and R&D Management of Albumin, Immunoglobulin and Virology.
Jeff has had a number of advisory roles including industry representative on Pharmaceutical Industry Council, a member of the Australian Red Cross Advisory Board and CSL representative on European Plasma Fractionation Association.
Maurice is a professional engineer with 28 years experience in manufacturing management operational and technical roles within the human and animal health, biotechnology and medical device sectors including 18 years in consulting roles. He is an expert in management of technical operations under GMP regulations and specialises in biopharmaceutical process scale up, optimisation and validation.
He has a thorough understanding of operational and quality policies, procedures and international regulations. Maurice has managed in excess of 350 compliance and operational projects of varying scale for clients nationally and internationally for organisations from those developing new products to mature players in these markets.
Maurice is Principal/Director of NewWayz Consulting Ltd. NewWayz multi-disciplined specialists are available as consultants or as value added resource for CBE projects.
Maurice is a current director of ISPE (Australia), previous chair of the ISPE Asia Pacific Affiliate Council and a member of ISPE’s Asia Pacific Regulatory and Compliance committee.
Paul has over 25 years experience in the Pharmaceutical and Life sciences industry as a Manufacturing/Operations Manager, Engineer and Consultant. From 2011 to 2014, Paul was the Manufacturing Manager for the Australian Red Cross Blood Service with overall responsibility for processing, testing and distributing of therapeutic blood products to the public and private hospitals within the states of NSW and ACT, Australia.
Prior to this, Paul had 21 years in project management, qualification and validation, Production / Manufacturing and Operations Management with Sandoz, AstraZeneca, Schering-Plough, Seer Pharma and iNova (previously 3M). Paul has extensive industry and consulting experience in compliance, interpretation and practical application of TGA/PICs and FDA GMPs. He also has experience in continuous improvement, change management and productivity improvement. Paul has worked on behalf of clients to obtain GMP licensing and remediate compliance gaps.
Paul is a current Director of ISPE (Australia).
Andrew has 20+ years experience in the design, construction, commissioning/validation and operation of a wide range high tech facilities, including pharmaceutical manufacturing, high containment, industrial cleanroom, hospital pharmacy and specialist research facilities.
This experience extends to facility layout, building fabric design, construction techniques, utility design, such as HVAC and purified water, process equipment and project management and encompasses all aspects of FDA, EU-TGA-PIC/s and associated regulations, local and international standards and general quality practices. Andrew has performed gap analyses on many pharmaceutical manufacturing facilities and sterile/cytotoxic dispensing suites to assess aspects of compliance, safety, design and rectification.
Andrew is a past president of ISPE (Australia) and is an active member in local and international standards committees. He is Independent Chair of ME-060 (Cleanroom Standards) for Standards Australia and committee member for TC-209 (ISO 14644 and 14698 suite of standards).
Alison has more than 30 years experience in the Biopharmaceutical and Diagnostics industry, in Operations and General Management roles – both in Australia and internationally. Her corporate experience includes 13 years with CSL Ltd in senior executive positions across the Animal Health, Biosciences and Pharmaceutical Divisions – managing veterinary and human vaccines, antivenoms, diagnostics and other biologicals manufacture..
Alison spent three years providing consulting services in technical, operational and strategic management areas to both Australian and international organisations. In 2009, she joined Genetic Technologies Ltd as Chief Operating Officer where she was responsible for the genetic testing laboratories and was instrumental in the due diligence and acquisition of a new breast cancer risk assessment test (BREVAGen). This test was subsequently launched onto the US market in 2011, following significant validation and US regulatory submissions (CMS/CLIA) and Alison assumed responsibility for the reimbursement program. In December 2012, she was appointed CEO of Genetic Technologies and retained this role until December 2014.
Alison has served as Director for a number of subsidiaries of Genetic Technologies Ltd.
Justine has over 20 years experience in the Pharmaceutical industry as a Quality Operations Director and Technical Operations Manager. From 2013 to 2016, Justine was Lead Director for Quality Operations in Australia, New Zealand and a joint venture site in India, with overall responsibility for leadership, quality systems, compliance, testing and release of pharmaceuticals, biopharmaceuticals and medical devices. Responsibility included operational and commercial quality organisations.
Justine has had responsibility for providing technical, operational and strategic leadership to ensure compliance in accordance with US FDA, EU-TGA-PIC/s regulations and local and international standards. Justine specialises in developing strategic quality plans and risk management plans, focusing on remediation strategies, quality enhancements and process improvements for operational efficiency. Combining a Microbiology background with an MBA specialising in business management and leadership, Justine works with clients to provide strategic and compliant solutions.