How to respond to GXP (GCP, GLP, GMP, GPV) Inspection and Audit Findings using Correction and Preventative Action (CAPA)

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:

• What is CAPA system?
• CAPA term and their application.
• What is CAPA and why is there so much emphasis on the use of CAPA in the regulated industry?
• Understanding regulatory requirements.
• How to investigate and use of root cause analysis to identify the root cause of CAPAs
• Documenting CAPA activities – what do regulatory inspectors expect?
• Apply and review CAPA case studies to enhance the webinar learning.

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:

• Clinical Development Managers and Personnel
• Clinical Research Associates
• Clinical Research Archiving and Document Management Personnel
• Quality Assurance Managers and Auditors
• Clinical Development Managers and Personnel
• Professionals working in Manufacturing
• Professionals working in Pharmacovigilance
• Professionals working in Laboratories
• CROs
• Project Management
• Sponsors and Non-commercial Sponsors
• Consultants
• Laboratories analyzing samples from clinical trials
• Regulatory Affairs
• Clinical Trial Supply
• Document Management
• To those departments who liaise / support drug development
• Legal, regulatory authorities and all other professionals who want to know more about compliance with inspections and audits

Instructor Profile:

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.

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