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

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.