Dr. Laura Brown, Ph.D., 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 more than 20 years’ experience of drug development and quality assurance in the pharmaceutical industry, including writing SOPs and auditing internationally and helping to prepare companies for inspection. 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 GXP audit consultancy preparing and managing SOPs. She has worked for several international companies including Glaxo Wellcome, Hoechst Marion Roussel, and Phoenix International. Laura is the author of a chapter on “Training QA staff” in the leading GXP book: “Good Clinical, Laboratory and Manufacturing Practices”. 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 SOPs and quality issues. Laura developed an e-learning module: “How to Prepare for Audit and Inspection” for Zenosis (A regulatory commercial e-learning training organization and is editor of an e-learning SOP series. 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, 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.
August 05 2019
01 : 00 PM EST
The General Data Protection Regulation (GDPR) came into force on 25 May 2018 and brought substantial changes to the rules around personal data and its use. Most companies have implemented requirements such as creating records for personal data processing activities, preparing data protection assessments. However, while the GDPR built on the previous data protection legislation, it represented a significant ..