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GCP Training
Certifying 2 Days Training - Principles of Clinical Quality Assurance Audits
In this Interactive GCP Workshop, you will learn about the changes and get an opportunity to better understand the implications of these additions for the quality management system of the sponsors and how to apply the principal of quality risk management into their day-to-day activity.

This introduction to the Principles of Clinical Quality Assurance Auditing has been developed to cover the principles of GCP and how they can be applied to clinical trial audits in consideration of both computerised system and data integrity considerations.

This interactive on-line workshop is developed and hosted by three experienced leading quality professionals, with broad experience of clinical trials in Europe, the UK and USA. It is recommended for delegates who are new to QA or wishing to move into auditing (1 to 3 years’ experience for example).

With a primary focus on European and UK requirements over two days delegates will be given the opportunity to understand GCP legislation and how it can be applied to individual audits and audit programmes using a risk-based approach. The course includes both points to consider for face-to-face audits and those conducted remotely.

As few clinical trials are successfully completed today without the use of electronic data capture systems and data collection tools, the workshop includes an introduction to computerised system validation and points to consider during routine clinical trials audits, as well as an overview of data integrity and application of the MHRA GXP Data Integrity Guidance.

By the end of the course participants will have:
  • Received an overview of the principles of GCP and how they can be applied to audits and audit programmes
  • Understood the basic principles of computerised systems validation and how the relate to clinical trial studies and processes
  • Engaged in discussions regarding the planning, conduct and reporting of audits
  • Practiced the development of audit plans using a risk-based approach
  • Discussed the inclusion of data integrity review to routine audits

    Dates and Time:
  • 9 November 2021 from 9.30AM to 5.00PM CET Time
  • 10 November 2021 from 9.30AM to 5.30PM CET Time
  • EFGCP Certificate of Completion based on Successful MCQ Test
  • Online Meeting
    Presented by:
  • Louise Mawer, Mirabilitas Ltd
  • Kathleen Williams, KEW Quality Ltd
  • Trev Simmons, TS CSV QA Ltd

Full Agenda and Speakers' Biography available in our Portfolio: Download the Training Portfolio

IMPORTANT: This Training has a minimum amount of 6 participants required and has room for a maximum amount of 24 participants. If the minimum amount of participants is not met by the 29th of October 2021, the course will not take place. Participants will be notified when the minimum amount of participants is reached and the course confirmed. In case the course cannot take place, registered participants will be fully reimbursed.
  • Seats Available: 7/24
  • Minimum Threshold: 6/6 - Threshold Reached
  • This course is Confirmed

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