With more than 45 years experience in the Biotechnology, Pharma- ceutical and Medical Device industries, Steve provides strategic solutions to regulatory and compliance challenges, along with advanced training courses. Steve has developed multiple training courses in GMP, GLP, Validation, Risk Management and Quality Systems. He also assists companies in remediation programs and prepares companies for regulatory inspection.

Rachel has over 25 years of experience across the biotech industry in commercial operations, strategic compliance and business management. By combining a science background with a passion for business and commercialising new products, she balances technical, patient and commercial realities. Rachel brings a strategic lens, while developing practical solutions, committed to developing both individuals and teams to achieve business goals and operational excellence.

Maurice has significant international experience as a subject matter expert and specialist trainer in science and risk based approaches to manufacturing across the biopharmaceutical industry, he is professional engineer drawing on 30 years’ experience in technical and consulting roles. Maurice is an expert in process design and validation under GMP regulations, who thoroughly understands international GMPs and current good manufacturing practice. 

Andrew has 30 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. As a consultant, Andrew specialises in identifying pathways and solutions to issues of design, compliance, quality and safety.

Lisa is a seasoned professional in the pharmaceutical and medical device industry, with a diverse background spanning from R&D to aseptic processing and sterile medicine manufacture to Quality Management Systems and auditing. Lisa volunteers with the Parenteral Drug Association (PDA) and is an active member of the PDA Board of Directors, PDA Regulatory Affairs and Quality Advisory Board (RAQAB) and the PDA Australia Chapter Board. 

Lyndall brings over 25 years of experience across pharmaceutical quality, regulatory systems, and medical research, with a proven track record in advising, auditing, and leading within complex manufacturing and compliance environments. Her deep expertise spans GMP systems, risk management, data integrity, regulatory compliance, and sterile and vaccine manufacturing. A former GMP Inspector at the TGA and senior quality leader in the pharmaceutical industry, she has contributed to the development of global standards (including new Annex 1).