Project Management for Auditors - Improving audit productivity for GCP, GMP and GLP

Why Should You Attend:

Auditing is essential to ensuring quality assurance of drug development. Each audit has a degree of complexity which needs effective project management. With ever increasing pressures to complete the audit promptly and to the appropriate quality standard, the effective use of project management can provide essential tools and techniques to achieve this. Indeed effective project management can be a key factor to successful completion of efficient auditing.

This presentation will provide you with an excellent understanding of project management skills, to apply to auditing in all GXP areas. You will be provided with an integrated project tool kit which can easily be used with your existing or future project management tools used for auditing. This tool kit has been used to significantly improve the successful completion of auditing on time to the right quality standard in many pharmaceutical organisations. The presentation will show you how to use these project management skills to gain the most benefit from them in your auditing activities.

We will discuss the basics of project management, including how you can achieve improved, resource utilization, and more timely audit conclusions of your auditing. You will then apply these techniques to improving productivity in the audit process. Using audit-specific examples, you will learn project planning, scheduling, control, and decision support concepts and methodologies -- the basics of project management. The techniques outlined in this session will significantly improve your productivity in planning and managing all audit projects.

Areas Covered in the Webinar:

• What is a Project Management framework for auditing?
• What are the benefits and relevance of project management to audit?
• Key principles of project management applied to auditing
• key project management definitions relevant to audit
• Defining project scope and requirements for an audit project
• Developing the Project Work Plan for an audit
• Defining activity dependencies and creating network diagrams for an audit
• Producing a project plan for an audit
• Monitoring and controlling audit projects
• Closing the audit project
• What are typical elements of a project plan for an audit?
• How to breakdown the work, scheduling, critical path considerations
• How to identify problems early in the process and understand the root causes of these
• How to Meet Today’s Audit Challenges with Project Management Techniques
• How to manage your project when you don’t know the final product at the onset
• Risk assessment and contingency in auditing
• Key Project Management Tips for Improving Audit Productivity

Who Will Benefit:

This webinar will provide critical assistance to FDA and EMA regulated companies currently carrying out or preparing to conduct audits for pharmaceutical, biotechnology, and biologics products in paediatrics. It will be relevant to all the GXPs regulated areas: GCP, and GMP.

• Quality assurance managers and auditors
• Audit support staff
• Clinical Development managers and personnel
• Clinical research associates
• Clinical Research archiving and document management personnel
• Clinical Development managers and personnel
• Audit Consultants
• Regulatory Affairs professionals
• Academic clinical trial site auditors
• Anyone interested better planning and execution of auditing activities in GCP, GMP and GLP.

Laura Brown
Independent QA and Training Consultant, Laura Brown Training and Development

Dr Laura Brown is an independent Pharmaceutical QA, Management and Training Consultant, and Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. Laura has more than 20 years' experience of Quality Assurance and managing international clinical trials including risk identification and management and risk based monitoring. She has worked for several companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. She has consulted with numerous pharmaceutical companies, suppliers to the pharmaceutical industry as well as academic institutions.

Dr Brown has an MBA with specialization in project management including risk management. She is also the external project management expert for a pharmaceutical e-learning MSc module in project management covering risk management, and the author of two books on project management including the leading book “Pharmaceutical Project Management” (Gower).

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