GxPpro - Consultancy

Jim Smyth

James is an experienced Qualified Person with over twenty years experience in both commercial and Investigational medicinal products in a Premier Multinational Pharmaceutical company. He has held a number of positions at Pfizer in Quality Control, managing testing laboratories and Quality Assurance, supervising and mentoring other QPs. He was involved globally in Pfizer in advising colleagues on the requirements of the new wave of Directives and setting policy.

James was a QP Assessor for the Royal Society of Chemistry between 2001 and 2010 and Chair of the RSC QP Panel of Assessors (2007-2010).

Brian Szukala

Brian has over 20 years experience in the pharmaceutical industry, several as UK Head of Training for two of the worlds most succesful pharmaceutical companies (Pfizer and Abbott Laboratories). He has been actively involved in the implementation of cultural change programmes, incorporating competency based performance management, values based leadership through to performance improvement initiatives (eg Lean Six Sigma, Class A MRPII, behavioural safety). Brian has designed and delivered courses in leadership, performance improvement, health and safety and other compliance topics.

Brian also has global experience of developing company training standards and has been involved with several UK public service bodies (eg Sector Skills Councils, NVQ Awarding Bodies, Skills Academies) in helping to identify workforce development needs and supporting initiative implementation across industry.

As well as working in the pharmaceutical arena Brian has managed the training operation at the Freight Transport Association, one of the UK’s largest trade associations responsible for training over 5000 sector Directors and Managers annually. Recognised as a European expert on various legislative topics and worked with UK government on the implementation of driver training legislation into the country plus numerous other driver behavioural change initiatives.

Presented at numerous seminars across the globe on a variety of performance improvement subjects, logistics topics and pharmaceutical compliance issues. Designed, developed and delivered numerous training courses and the originator of the concept of behavioural Good Manufacturing Practice (bGMP®) and behavioural Good Pharmaceutical Practices (bGxP®).

Henny Koch

Upon completion of his education in analytical chemistry, Henny Koch started his employment in the pharmaceutical research and development department of Organon in 1975. Within R&D his expertise and focus were on analytical method development and pharmaceutical formulation technology. In 1977 he joined Organon’s sister OTC company Chefaro International as formulation specialist in colloid chemistry and later became development laboratory manager. In 1993 he moved to international manufacturing and additionally holding the position of manager processing of the production department in Rotterdam.

August 2000 he rejoined Organon to apply his broad pharmaceutical experience in compliance control and Quality Systems. In 2006 he moved to Global Quality to participate as Compliance Manager in the setup of a business wide Quality Management System for Organon BioSciences wherein he was assigned for the manufacturing (GMP), ISO (Medical Devices) and Management related systems.

After the take-over by Schering Plough he became a program manager for Global Clinical Quality Systems. When Schering Plough merged with MSD /Merck, he decided after 36 years of employment in the pharmaceutical arena, to start his own business and founded Qimp Management Systems Ltd. Qimp Management Systems B.V. is a company with focus on improvement of quality, compliance and business sustainability with focus to be:

“Your motivational partner for sustainable improvements in Quality and Compliance”.

Henny holds a Master in Quality Management and his major goal is to support companies striving for efficient and effective quality processes, to achieve operational excellence and leading to cost effective health care products and improved patient safety.

Driven to continuously broaden the intrinsic scope and to excel in an adventurous environment, being:

• Advocate of Total Quality Management approach; Hoshin Kanri, Gemba Kaizen and Lean Six Sigma.
• Regulatory and quality systems expert covering the product life cycle for medicinal products and medical devices.
• Experienced global lead auditor in pharmaceutical compliance and ISO based systems.
• Thesis Quality Management (2010): How to create reference for Pharmaceutical Process Management and GxP regulations to improve process sustainability and quality awareness? And resulting in a process interaction driven QA management model.
• Initiator and project manager for a modern Quality Management System in pharmaceutical industry.
• Motivational speaker and trainer on conferences and courses.