BSc MSc PhD CChem MRSC
I am a QP via permanent provisions with detailed working knowledge of the European and FDA regulatory requirements with over 30 years of experience auditing pharmaceutical manufacturing sites across Europe and USA, as well as preparation for and fronting of EU and FDA regulatory inspections. I was actively involved in development of ISO 15378 (packaging components) and PS9000, 2011 (Packaging standards for pharmaceutical products).
I am acknowledged expert in quality management system for pharmaceutical supply chain, and currently advising companies on developing and validating Cold Chain Supply process. I am a regular speaker at Pharmaceutical industry conferences in Europe and the USA. I am co-chairman of the European Compliance Academy (ECA) advisory board and the Chairman of the EU GDP Implementation Guidance Preparation Working Party, and a visiting lecturer at the London Metropolitan University.