ComplianceOnline

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

Instructor: Laura Brown
Product ID: 701982
  • Duration: 60 Min

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$499.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

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Read Frequently Asked Questions

This Project Management training for Auditors will help you understand how to apply project management principles to auditing to ensure efficient and effective quality assurance of drug development.

Course "Project Management for Auditors - Improving audit productivity for GCP, GMP and GLP" has been pre-approved by RAPS as eligible for up to 1 RAC credits towards a participant's RAC recertification upon full completion.

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 Seminar:

  • 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.

Instructor Profile:

Dr. Laura Brown, PhD, MBA, Diploma Clinical Sciences is an independent QA and Training Consultant in the Pharmaceutical Industry, and Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. Laura has more than 17 years experience of running clinical trials and clinical quality assurance in the pharmaceutical industry.

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 GCP 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 GCP 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 GCP 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.

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, GCP , the clinical trial directive, managing clinical trials, QA Management and business skills, how to prepare for audit and inspection.

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