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

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.

Recorded Version

$299.00
1x Person - Unlimited viewing for 6 Months (For multiple locations contact Customer Care)
rec Recorded Link and Ref. material will be available in My Account Section
Last Recorded Date: Apr-2019

Training CD / USB Drive

$399.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days
Customer Care

Fax: +1-650-362-2367

Email: customercare@fdatrainingalert.com

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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.
Instructor Profile:
Laura Brown 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).

Refund Policy

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. FDATrainingAlert 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 customercare@fdatrainingalert.com call +1-888-771-6965 (Toll Free).

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