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.
June 10 2019
01 : 00 PM EST
Currently pharmaceutical and medical device industry guidance for quality in clinical development is fractured across multiple documents from multiple sources. Also, with the implementation of ICH GCP R2, it is expected that the CQMS should be risk-based.Regulatory inspectors including those in Europe, the FDA and UK’s MHRA now expect a CQMS to be in place. However, there is no industry-wide conceptual fram..
April 22 2019
01 : 00 PM EST
This webinar will help Sponsors, CROs in the US, EU and internationally; understand how to write SOPs to comply with inspection requirements.The lack of or inadequate standard operating procedures (SOPs) continue to dominate the FDA's and other regulatory inspector’s inspection observations. This is often caused by poor writing and management and control of SOPs. SOPs need to be easily understood by all tho..