Alison Tennent is a chemical engineer with a background in process and equipment validation within the pharmaceutical and medical device industries. Also a competent technical writer and quality systems consultant, Alison has successfully delivered suitable and effective quality management systems to a number of our clients. Alison also has experience in the Principles of (Good Laboratory Practice) GLP, routinely working as a quality assurance manager for our clients.

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Bob Tribe is an experienced, approachable, industry veteran who has been a key player in the development of the GMP standards and their application within Australia and internationally. Bob was previously the Chief GMP Auditor for TGA, Australia  (1980 – 2003) and Chairman of the Pharmaceutical Inspection Cooperation Scheme [PIC/S] (2000 – 2001). Current regulatory advisor to the ISPE, special advisor to a number of regulatory authorities seeking PIC/S accreditation.

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Gordon Farquharson is widely recognised as a world leader and expert in sterile products manufacture, clean room design and maintenance and utilities for the same.  Gordon is the Chair of British, CEN and ISO committees responsible for development and deployment of the ISO 14644 family of cleanroom standards. He is also an advisor to the EMeA concerning the revision to Annex 1 of the EU GMP in February 2008 and a member of the WHO expert committee (WHO Pharmaceutical Water GMP; Sterile GMP Annex 1).

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Norm Cheale has significant consulting, project and operational management experience in the pharmaceutical, medical devices and veterinary fields. Norm managed the validation of a green-field, sterile, LVP, biological manufacturing facility. Norm was  responsible for the unique validation of the various safety features of a state-of-the-art, PC4, veterinary, diagnostic and research containment facility. Norm’s wide experience and practical approach provides cost effective solutions to your problems.

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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.

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Tim Saunders is a UK registered pharmacist with 10 years experience in clinical pharmacy and 20 years in the pharmaceutical industry.

He has extensive experience in managing product development, technology transfer, validation and clinical trials, both in the UK and Australia. His project management and quality systems skills are regularly utilised in the pharmaceutical and medical devices industries, including swift and effective remediation of regulatory non-compliance.

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Trevor Schoerie has 21 years manufacturing and 8 years consulting experience in the chemical, pharmaceutical, pesticides & veterinary drugs industry. More recently the consultancy has included the oversight of facility design, construction, commissioning, validation and operation. Many of the more recent projects have involved remediation of practices to international regulatory authorities, i.e. FDA, TGA, Medsafe and PIC/S standards. Trevor believes strongly in sensible, practical compliance that delivers business results, not just audit success.

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