John Montalto

John Montalto is a training manager with PharmOut Pty Ltd, one of the largest GMP and regulatory consultancies in the Asia-Pacific region. John routinely trains and consults to multinationals, regulatory agencies and small business in pharmaceutical validation, project management, quality management systems and risk management.
John has had extensive 'in the trenches' experience and line responsibility for the delivery of several 'turn-key' projects within vaccine, device and anti-viral manufacturing facilities. John has also served a valuable apprenticeship outside of the life sciences industry enabling him to 'cross pollinate' his experiences.
During his time at Kodak, John was able to implement and develop lean manufacturing projects, including 5S upgrades, Kaizen events, lean manufacturing and 'just-in-time' chemical delivery processes. Additionally, John spent several years in pharmaceutical production management roles implementing and maintaining quality management systems, and leading major scale validation projects.
John now focuses on transferring his experience through training and improving the skills of regulated industry personnel throughout Australia, New Zealand, Asia and South Africa. John has developed a reputation for his 'active' style of presentation and has delivered an array of training presentations in many topics including:

• good manufacturing practices
• quality risk management
• computerised systems validation
• process and equipment validation
• lean manufacturing.

Over many years, PharmOut have developed a series of professional development training programs. These range from on-site and off-site training courses, and e-learning modules. John has played an instrumental role in developing these with Bob Tribe, ex TGA, Head of the GMP compliance.
John is a current Director of the Australian affiliate of the International Society of Pharmaceutical Engineering and a consultant to the Food and Agriculture Organisation of the United Nations.