Why Should You Attend:
The GXP Inspectorate have assessed many responses to GXP inspection reports and responses that require amendment/clarification. This assessment has led to additional time spent by the inspector and the inspected organization in order to close the inspection after responding to inspection findings. Therefore, many inspectors and auditors are now looking for a CAPA approach to respond to inspection and audit findings as a way to improve the response to findings and also to identify the root cause of the issue.
This webinar aims to enable you to understand how to respond to the GXP inspection report findings using CAPA. It will also increase your awareness of the GXP Inspectors’ expectations and provide assistance in how to formulate a response.
This webinar will provides an understanding of how to run effective CAPA procedure that will meet the regulator’s requirements as well as benefit the organization. It will cover areas that can cause confusion including terms, definitions, deviations, discrepancies, non-conformances, documentation needed and applying the CAPA approach through application of the root cause analysis technique to inspection findings.
Areas Covered in the Webinar:
Who will Benefit:
This webinar will provide critical assistance to FDA and EMA regulated companies including professionals in pharmaceutical, biotechnology, CRO, SMO, vendor companies, or study sites including investigator initiated studies who are subject to inspection or audit.
It will also be of interest to personnel such as:
Dr. 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 working in the pharmaceutical industry and quality assurance, including carrying out CAPA for responding to audit and Regulatory Inspection findings and working as an auditor 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 GXP 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 GXP 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, Regulatory requirements, QA Management and business skills, how to prepare for audit and inspection, how to audit etc.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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