Webinar Duration: 60 minutes
RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)
SPEAKER: Laura Brown
This webinar will help Sponsors, CROs in the US, EU and internationally,understand how to write SOPs to comply with inspection requirements.
Why should you Attend: 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 those who have to follow them. Well written and effective SOPs are not only a regulatory requirements, they also make good business sense. Too often employees fail to follow SOPs because they can’t understand them, and too many times we’ve seen procedures being constantly revised.
This leads to lengthy and expensive investigations and costly revisions. The webinar has been specifically designed to learn how to create and review SOPs, and generate a system for training and implementation of effective and compliant written procedures. This webinar will assist you to prepare for inspection of SOPs, particularly since such inspection readiness of SOPs are taking considerable time to prepare for. Inspections of SOPs of critical activities that impact business success on several levels. Therefore, preparation and management of the inspection and audit process of SOPs is an important business activity, not just a distraction from day to day routine.
Potential adverse consequences to the company if an inspection of SOPs does not go well range from time consuming responses to regulatory observations, to publicly available Warning Letters, delayed product approvals, and the specter of civil or even criminal litigation by the FDA. These consequences are preventable with good preparation and management of SOPs.
Areas Covered in the Session:
– Understand why we need written SOP procedures
– Gain an insight into expectations for an effective written documentation
– Understand Regulatory requirements for the creation, compliance and maintenance of SOPs
– Gain techniques for creating effective SOPs and other written documents to minimize costly revisions
– Understand roles and responsibilities for the review and approval of written documents consistent with compliance requirements
– Learn how training and implementation of SOPs should be carried out to meet inspectors expectations
– Ensure you have an effective control, archival and disposal of SOPs
Who Will Benefit:
– Drug Research and Development Managers and Personnel
– Clinical Research Associates
– Clinical Research Archiving and Document Management Personnel
– Quality Assurance Managers and Auditors
– Clinical Development Managers and Personnel
– Project Management
– Sponsors and Non-Commercial Sponsors
– Sponsors who Have their Own Laboratories for Analyzing Clinical Trial Samples
– Laboratories Analyzing Samples from Clinical Trials
– Regulatory Affairs
– Clinical Trial Supply
– Document Management
– To those Departments who have SOPs
– Legal, Regulatory Authorities and all Other Professionals who want to know More about – Inspection of SOPs
Dr. Laura Brown , PhD, MBA, Diploma Clinical Sciences, is an independent QA and training consultant in the pharmaceutical industry. She is a managing director with LB Training and Development Ltd., course director for the M.Sc. in Clinical Research, School of Pharmacy at the University of Cardiff, and course director for M.Sc. Regulatory Affairs, TOPRA. Dr. Brown has 20 years experience running clinical trials and clinical quality assurance in the pharmaceutical industry, and auditing clinical trials internationally. She has held a number of international and senior management QA positions in the pharmaceutical industry including her role as an associate director with a leading GCP audit consultancy.
She has worked for several international companies like GlaxoWellcome, Hoechst Marion Roussel and Phoenix International. Dr. Brown has published material on the new EU Clinical Trial Regulation and also a practical guide to the current regulatory requirements for carrying out clinical trials in the EU. She has penned a chapter on training QA staff in the leading GXP book “Good Clinical, Laboratory and Manufacturing Practices” (2007). She has authored SCRIP’s latest GCP guide and one entitled “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 in training courses on QA and GXP issues.
Dr. Brown 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). She runs many training courses on topics such as: 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.