QP mathematics and statistics

Andy has over 35 years of pharmaceutical industry experience, beginning at Smith and Nephew in 1985 as a microbiologist, progressing to QA Microbiology Manager in 1996. During that time, he gained experience in QA and QC activities of the manufacture of sterile eye drops (terminally sterilized and aseptically filled), aseptically filled sterile creams and non-sterile syrups. In 2003 he became the RSSL Pharmaceutical Training Manager with responsibility for providing commercial pharmaceutical training courses. In 2007, Andy moved to Catalent pharma Solutions, in Swindon, as Microbiology Manager leading a team responsible for microbiological control of freeze-dried tablets and soft gel capsules. Andy gained valuable experience in regulatory inspections, failure investigation, risk assessment and operational excellence activities including Lean Six Sigma Kaizen events. In 2012 Andy set up ABM Consulting Ltd which offers services specializing in Microbiology, QA and Good Manufacturing Practice. Andy is also treasurer for the UKs foremost microbiology organisation, Pharmig.

With over 30 years industry experience, Donna Connew has worked in stability and method development laboratories, process technology, GMP auditing, incoming materials QC, supplier quality, production QA and clinical trial QA. A QP since 2001, Donna has worked in the generic pharmaceutical industry and also as a contract auditor of API facilities.