Basic audit findings and EU GMP clauses

Greg qualified as a pharmacist and completed a PhD prior to joining the pharmaceutical industry. He worked for Wellcome, GlaxoWellcome and GlaxoSmithKline for 37 years in a wide range of technical and leadership roles in the pharmaceutical development of new medicines. Greg has a passion for pharmaceutical quality management, developed over 30 years in quality-related roles in a GMP environment, and more specifically in the last 10 years in dedicated quality and risk management roles. Greg is a subject matter expert in data integrity and has played a leading role in public consultation on Regulatory Authority Data Integrity Guidance. Outside of work Greg enjoys sport and revelled in the experience of bringing the two together whilst being seconded to the Anti-Doping Team for the London 2012 Olympic and Paralympic Games.

David is a Computer Systems Validation and Compliance expert. He has worked in the IT/Computer Systems arena for almost 30 years, the last 16 years he has provided Consultancy, Auditing and Training to the pharmaceutical/biotech and healthcare industry across the UK, Europe, Asia and the U.S.A. He is a Chartered Engineer with both the MIET and the MInstMC and a member of the GAMP MES SIG. He is involved in our data integrity and computers systems auditing courses.

Mark is a Fellow of the Royal Society of Chemistry with over 25 years’ experience as an analytical chemist. He is an expert in chromatography, spectroscopy and pharmaceutical dissolution testing. Until September 2013, he was Scientific Manager at Quay Pharmaceuticals, a contract research and manufacturing organisation, where he was responsible for analytical development and technical training. He now works as a trainer and consultant specialising in laboratory quality systems, chemical analysis and technical writing.

Dr Douglas Thorogood is a Quality Assurance and Sterility Assurance Expert. His former roles include senior management positions in Production, QC and QA, Regulatory Affairs and Research Development for Baxter Healthcare located in U.K., U.S.A. and Belgium. His experience also includes the use and application of isolator technology and development of Aseptic Processes. Douglas’ qualifications include a Bachelor of Medicine and Surgery, from Guys Hospital London University and a Doctor of Philosophy.

Ron has been involved in the learning and development industry for over 20 years. He is a Fellow of the Learning and Performance Institute and in 2004 received the LPI ‘Colin Corder’ award for outstanding services to the training industry. He is the architect behind our website and our learning platform and also develops the web-based learning courses that we now offer to support many of our learning programmes. In addition, he also provides general business support on strategy and sales and marketing.

Peter is arguably the finest Quality Management Systems tutor in the business, his enthusiasm for quality system thinking and his outstanding training abilities have gained him international praise and appeal. He is an IRCA registered Quality Management Systems Lead Auditor. Peter is an enthusiastic trainer with over 30 years of quality and industrial experience, including spending the past 15 years working closely with pharmaceutical organisations small and large.

Neil is an experienced Quality leader and Qualified Person with over 35 years of pharmaceutical industry experience. He has been a registered QP on several site MIAs and MIA (IMP)s for multiple dosage forms for human pharmaceutical medicinal products, including sterile products, solid dose and ATMPs. Neil also has experience of being a registered QP on a site Man(A) veterinary medicines licence. In addition, he has also acted as a successful QP Sponsor and particularly enjoyed this role.

As well as being a registered QP, Neil has also been named on both UK and Swedish GDP Licences as an RP, and gained substantial GDP knowledge across global supply chains.

During his career he has built extensive knowledge of European and Global GMP and GDP quality systems and has a successful record of team management, including internationally. He has worked for major pharmaceutical companies including GlaxoWellcome, Wyeth, Novartis, Allergan and Boehringer-Ingelheim Animal Health. Neil is also an experienced Corporate GMP Global quality auditor.

Christine started her career with Sanofi Winthrop working in QC over 20 year’s ago, moving through to the QA Department and from there into QP training as her career progressed, finally working as Head of Quality. She has extensive experience of working in both ethical and generic pharmaceutical companies and with a wide range of dosage forms. She is eligible to work both as a Qualified Person (QP) and a Responsible Person (RP), having extensive GMP and GDP experience internationally.

Andy started working in the Pharmaceutical industry in 1985 as a lab technician for Smith & Nephew. Following this he had a number of roles culminating when he took over as QA Microbiology Manager. In 2003 he moved into Pharmaceutical Training and then in 2007 he moved back into Microbiology when he took up the position of Microbiology Manager for Catalent Pharma Solutions. Since 2012 he has operated as a consultant specialising in Microbiology and Quality Systems.

Vanessa started her career in the pharmaceutical industry working for Celltech (now Lonza) in 1989 primarily working in their manufacturing sites, as a cell culture and fermentation technician. After moving to Evans Medical Limited (now Novartis Vaccines), Vanessa worked in Quality Assurance and then specialised in Documentation. Vanessa then worked for Oxoid (now Thermo Fisher Scientific Oxoid Ltd) for 3 years also in Quality Assurance where she trained as an internal auditor. Following this, Vanessa became a Customer Operations Consultant for GlaxoSmithKline providing first line support during and after their SAP implementation specialising in production and manufacturing areas.

Ruth has over 35 years’ experience in the pharmaceutical industry beginning in analytical R&D and Quality Control functions before transitioning to Quality Assurance in 2002. She became a full time Global Quality GMP auditor in 2007 for a biologics company, conducting internal manufacturing and external supplier audits. Most recently Ruth gained experience in Good Clinical Practice and Good Pharmacovigilance practice Quality systems and has led audit and inspection management activities for all GxPs. In 2016 she resumed her full-time audit career as a global quality auditor and after 2 years of extensive global travel and GMP/GDP audits, she held the position of Director of Global Quality managing a team of GxP auditors and promoting improvements to the audit quality systems and working practices.

Matt is a dynamic, energetic and authentic trainer who demonstrates his passion and communicates this to all who encounter him. He began his Pharma career at Napp Laboratories before having short spells in related industries. He then spent 15 years with GlaxoSmithKline gaining extensive knowledge of GMP from roles in Packaging, Logistics and QC.

More recently, Matt worked as GMP Learning and Development Manager for Lonza Biologics and draws on all his varied experience to create a lively, relevant training environment.

Emma has worked in the pharmaceutical industry since 2010 and has experience in sterile biologics, medical devices, and homeopathic products in cream, tablet, powder and liquid dosage forms. She worked for 6 years at Nelsons, an FDA regulated homeopathic company in QA and set up the supplier qualification programme gaining Lead Auditor certification in the process. She then moved to Nicovations within the medical device sector, working as QA in the development and authorisation of new medical devices. Most recently Emma has spent 5 years working at Boehringer Ingelheim with sterile biologics as Lead Quality Systems Specialist, as well as Aseptic Processing Specialist supporting the filling department.

Emma’s particular interests are quality management systems and the individual elements within them, including problem solving, change management, management review, training and continuous improvement.

Dominic Parry has worked in the pharmaceutical industry since 1992 and is a leading pharmaceutical quality management specialist.  He initially worked for Evans Medical Limited as a Production Development Scientist.  He then moved to Hoechst Marion Roussel where he worked as a Quality Assurance Officer and then Validation Manager for the sterile manufacturing operations.

Over the past 20 years he has worked as a leading pharmaceutical trainer and Quality Management System specialist.  He works closely with pharmaceutical companies and their suppliers on evaluating, developing and continually improving their quality systems so that they add real-value to organisations.  He has a real passion for training in the pharmaceutical industry and has presented GMP and Quality Management related training courses all over the world.  He is an IRCA registered GMP Lead Auditor and regularly performs audits of pharmaceutical companies and their suppliers.

Susan began her career in the Pharmaceutical industry as a graduate in 2002 taking on the role of Regulatory Affairs Manager for a newly established Parallel Import company (Manufacturing Assembly only Licence). During this time, she successfully streamlined and automated the parallel import application process and designed and implemented the Quality Management System. She also developed the internal audit programme and successfully guided the company through GMP/GDP inspection with the MHRA. She now has over 20 years’ experience in the industry and has been registered as an RP for over 10 years. More recently she has also been registered as an RPi.