Quality Management Systems - QP Module

Mike Halliday has extensive pharmaceutical manufacturing management and QA experience, gained over 20 years working for three major international pharmaceutical manufacturers. Before joining NSF in 2003, he was Associate Director, Global Audit and Compliance for Wyeth Europa. He was also previously a partner at David Begg Associates (DBA).

Mr. Halliday is eligible to act as a Qualified Person and is an honorary lecturer at the University of Strathclyde.

He has broad experience in the manufacturing management and QA of a wide range of sterile and non-sterile dosage forms and is fully conversant with current EU and FDA GMP regulations and requirements. He has extensive experience in international QA auditing of a wide range of pharmaceutical manufacturers and specialist distributors in Europe, the Middle East, America and Asia Pacific.

Areas of recognized expertise include:

• QP training
• Packaging and labeling control
• GMP legislation
• API manufacture and control
• Auditing and self-inspection skills – Education of auditors
• Supply chain distribution

Rob Hughes has worked in the pharmaceutical industry for 30 years. He supports organizations in systems development and implementation, mentoring, staff development, training and process mapping.

Mr. Hughes began his career in tablet analysis and supplier assurance at Glaxo, where he underwent training as a Qualified Person. He subsequently joined ICI (later Zeneca) as Quality Assurance Officer responsible for tablet manufacturing at Macclesfield. Later he had responsibility for the quality assurance of liquids and creams and management of the product release office. After leading a project to prepare for the first FDA inspection of API manufacture at Macclesfield, he was seconded to the Bristol API plant as Quality Assurance Manager.

Mr. Hughes then moved to Central Operations QA initially with responsibilities for the development of QA systems for the international supply chain and the management of post approval dossiers, and subsequently the development and implementation of the international QA strategy and supporting systems.  During the merger with Astra, Rob was responsible for devising the structure of QA in operations and development. Post merger he assumed responsibility for the development of the corporate quality management system and the strategy for process analytical technology.

After transferring to R&D as Head of QA for drug substance and drug product development, he assumed leadership of the continuous improvement team responsible for improving R&D performance from pre-clinical to the end of Phase II. During this period, he worked with industry colleagues to produce a lifecycle guide to change management under the ISPE PQLI initiative.

David Selby has 40 years of experience in the pharmaceutical industry, primarily in roles requiring knowledge of GMP and the regulatory environment. He is eligible to act as a Qualified Person under EU Law. With this breadth of experience, Dr. Selby is currently focused on auditing, risk management, pharmaceutical quality systems and all aspects of validation and qualification. He helps companies prepare for regulatory inspections (both EU and FDA) and has developed the IRCA Accredited Pharmaceutical GMP auditing course.

Dr. Selby spent several years in research and development at Glaxo, before moving into international GMP compliance auditing and then becoming responsible for the manufacture of tablets and then antibiotics at the Glaxo site in County Durham, UK. Subsequently he occupied the role of Site Quality Assurance Manager and most recently was the Site Manager.

Dr. Selby served for a full term of nine years on the board of directors of the International Society of Pharmaceutical Engineering (ISPE). In 2003-2004, he was elected Chairman of ISPE and was the first non-American to be so honored.  He has been involved in many ISPE initiatives and the organization of many conferences.  He is a founder member and chairman of the GAMP® Forum and has chaired and is currently a member of ISPE’s PQLI Management Committee.