Michael Hopper
Mick has over 30 years experience of working in the pharmaceutical Industry, primarily for Pfizer. Having started his career in Quality Control, where Mick held several Technical and Management roles he moved on to Quality Assurance where he gained experience in both API and Drug Product manufacturing environments. Following his extensive experience in a quality environment, Mick moved to an HR learning development role where he managed several large change projects as well as actively working with management development programmes, coaching, team development and managing all of the NVQ schemes for Pfizer.
Following his successful career in HR, Mick moved back to Quality Assurance where he led the Development and implementation of a GMP learning and Development strategy for over 1,000 people as well as leading several global GMP projects. Before leaving Pfizer, Mick moved to a business support role where he gained his green belt accreditation and led the implementation of several improvement initiatives including Human Error management, Quality Risk Management and yellow belt development.
Mick set-up GxPpro after leaving Pfizer and has been working as a consultant where he has developed laboratory Technical Certificates for the new apprenticeship framework, designed and delivered several GMP training workshops globally, worked as an External verifier/consultant for an awarding Organisation. Mick has also worked with the Royal Society of Chemistry and also lectures in Quality at Kingston University
Mick is a regular speaker at ECA conferences and has also contributed to books specifically for the pharmaceutical Industry.
Stephen Belsey
Steve has 27 years experience in the research, development and manufacture of pharmaceuticals. From Pfizer’s Global Research and Development Department in Sandwich, he brings considerable skills and knowledge in the following areas:
- The development and validation of regulatory and non-regulatory analytical methods.
- The transfer analytical methods between global sites.
- Qualification of reference standards/materials.
- Qualification (IQ/OQ/PQ) of off the shelf and bespoke analytical instruments.
- FMEA analysis and contingency planning.
- Resolving atypical analytical chemistry challenges.
- GAMP (Lifecycle documentation)
As part of a global initiative, he spent 5 years within the Technology Development group, leading the development of a bespoke analytical instrument, developed to make significant savings in sample preparation and analysis times.
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®).
“Your motivational partner for sustainable improvements in Quality and Compliance”. Henny Koch