Laura Brown PhD, MBA, Diploma Clinical Sciences, is an independent QA and Training Consultant in the Pharmaceutical Industry as Managing Director LB Training and Development Ltd. , Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff, and Course Director MSC Regulatory Affairs, TOPRA . Laura has almost 20 years’ experience of running clinical trials and clinical quality assurance in the pharmaceutical industry, including auditing clinical trials internationally. Laura Brown has held a number of international and senior management QA positions in the pharmaceutical industry including as an Associate Director with a leading GCP audit consultancy. She has worked for several international companies including GlaxoWellcome, Hoechst Marion Roussel and Phoenix International. Laura is author of a chapter on “Training QA staff” in the leading GXP book: “Good Clinical, Laboratory and Manufacturing Practices” (2007). She is author of SCRIP’s latest GCP guide and a “Practical Guide to the Clinical Trial Directive. She is also co-author of several books including “Developing the Individual” and “Project Management for the Pharmaceutical Industry”. She has regularly lectured at conferences and on training courses on QA and GXP issues.

Laura developed an e-learning module: “How to Prepare for Audit and Inspection” for Zenosis (A regulatory commercial e-learning training organization) in 2008 and is editor of an e-learning SOP series for Henry Stuart Conferences (2013). Laura runs many training courses both on public courses and in-company on topics including: pharmaceutical project management, understanding the pharmaceutical industry/drug development, writing and managing SOPs, GCP , Regulatory requirements for Clinical Trials, the clinical trial directive, managing clinical trials, QA Management and business skills, how to prepare for audit and inspection, how to audit etc.