2017 GMP, Engineering & Validation Forum – Speaker Bios

Trevor Schoerie - GMP, Validation and Engineering Consultant

Trevor Schoerie is a thirty year industry veteran and founding owner of PharmOut, Trevor has substantial, practical, hands-on experience in GMP, auditing and validation. He has a thorough knowledge and understanding of the whole product lifecycle.

Trevor has been consulting for 12 years, designing, building, validating and operating plants and consulting directly to regulatory agencies.

Bob Tribe headshot

Bob Tribe has over three decades of pharmaceutical regulatory compliance experience, and is regarded as a true expert in the field. As Chief GMP Auditor at the Australian TGA for 23 years, Bob had a hand in creating many of the GMP requirements now in place. He now consults to manufacturers on complying with them.

Bob also consults to many GMP regulators around the world, assisting them reach the PIC/S level of regulatory control. He has assisted the Health authorities of South Africa, Israel, Cyprus, Ukraine, Indonesia, Taiwan, South Korea and Hong Kong in obtaining PIC/S membership. He works frequently in developing countries, supporting their efforts to establish safe and compliant pharmaceutical manufacturing facilities.

While at the TGA, Bob’s expertise was recognized by his appointment to Deputy Chairman of the PIC/S during 1998-1999. This was followed by a tenure as Chairman of PIC/S from 2000-2001.

In 2004 Bob was the recipient of the US Food and Drug Administration (FDA) Commissioner’s special citation Award as a member of the ICH Q7A Expert Working Group (“for outstanding cooperation and achievement in developing an internationally harmonised GMP guidance for APIs used in human drug products”).

In 2005 he was the recipient of the John Martin Memorial Award issued by the NSW Pharmaceutical Science Group of The Royal Australian Chemical Institute (“For exceptional leadership and service to the Australian Pharmaceutical industry”).

Specialties: Assists GMP regulatory authorities improve their systems and procedures prior to being assessed for PIC/S membership.

gordon-faruharson-headshot

Gordon Farquharson is a Chartered Engineer with a unique blend of regulatory, technical and operational experience. He has conducted a broad spectrum of international audits, inspections and training assignments, encompassing technical aspects, GMP compliance and operational due diligence.

Gordon is also active in developing standards and guidance within the global pharmaceutical industry (PIC/S, EU, USFDA, WHO).

Bryan Wright - ex Head of MHRA GMP - Headshot

Bryan Wright has extensive European regulatory compliance having spent most of his 22 years at the MHRA as GMP Inspector, later as a GMP expert inspector, the last 5 years as the Head of GMP/GDP.

During that time he had oversight of significant growth in the number of inspectors in response to increased regulatory demand within the EU and abroad. He retired from MHRA in 2011 and now works as a pharmaceutical consultant in the UK.

He established his own company WorkingWright Ltd, and for a number of years Bryan has been the European Regulatory Affairs Advisor for ISPE, continuing his passion to improve health outcomes for this prestigious non-profit organisation.

Jacob MacDonald has incredibly diverse experience, whilst initially training as scientist he has had a proven track record working in a highly regulated environments as a Chemist, Project Manager and Validation Manager. He has led teams in the design, construction and validation of Facilities Equipment and Systems to meet the challenges of a high potency manufacturing environment. He has extensive expertise in process systems and technical transfer projects. Jacob also has excellent technical writing skills, business management and GMP knowledge (FDA, PICs, EMA).

Ashley Isbel 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

Seamus Orr is a Senior Consultant, has over 10 years of experience consulting to the pharmaceutical and biotechnology industries. His expertise includes regulatory compliance, technical writing, procurement and project management.

Seamus is an engineer and is experienced in design, validation and project management involving process systems, equipment evaluation and qualification and installation and upgrade of pharmaceutical plants.

Eoin Hanley 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.

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.

Cameron Roberts is a chemical engineer with over 15 year’s process engineering experience across pharmaceutical manufacturing, nanoparticles and resource efficiency.  He specialises in process design, commissioning, validation, project management and resource efficiency auditing.