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Principles of Clinical Quality Assurance Audits

A two days Certifying Virtual Open Training by the Quality Working Party

Description

Event Training
Type Virtual Event
Language English
Date(s) 12 & 13 Dec 2022
Day(s) 2 Day(s)
Duration 8 Hours / Day

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 systems and data integrity.

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.

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 GXP Data Integrity Guidance.

Trainers:

  • Louise Mawer, Mirabilitas Ltd
  • Kathleen Williams, KEW Quality Ltd
  • Trev Simmons, TS CSV QA Ltd

Certificate: Principles of Clinical Quality Assurance Audits

  • Principles of GCP
  • Principles of GCP Audits
  • Routine GCP and Clinical Trials Audits
  • Audit Planning
  • Computerised System Validation Principles & Practices
  • Audit Planning and Computerised Systems
  • Data Integrity in Audit Practice

A minimum number of registrants is necessary to run this course. As soon as the threshold is reached, all registered participants will be informed that the course is confirmed. Information on the number of registered participants can be found on our Website’s Dedicated page.

Minimum Number of Participants: 6
Maximum Number of Participants: 24

In case the minimum number of participants is not reached by the 30th of November 2022, the Training will be Cancelled, and all registered participants will be fully reimbursed (should they have already paid).

UPDATE: Minimum number of participants reached, this training is confirmed to take place.

Programme

Monday 12 December 2022
9:30 Opening of the Training
10:00 Introduction & Welcome
10:30 Principles of GCP
An overview of GCP Principles applied in Europe, the UK and Worldwide including EU Clinical Trial Directives, EU Clinical Trial Regulation, ICH GCP (R2 & R3) and the UK Medicines Regulations
11:00 Break
11:15 Principles of GCP (Continued)
An overview of GCP Principles applied in Europe, the UK and Worldwide including EU Clinical Trial Directives, EU Clinical Trial Regulation, ICH GCP (R2 & R3) and the UK Medicines Regulations
11:45 Principles of GCP Audits
- An overview of Auditing Principles & Practices - On-site and Remote Audit Considerations
12:45 Lunch
13:30 Computerised System Validation Principles & Practices
- Key legislation – an overview of important global guidance - An introduction into computerised systems validation - Comparison of V-Model/System Development Lifecycle and Agile methodologies - Key records and evidence for audit - Role of the Sponsor in GCP
15:15 Break
15:30 Routine GCP and Clinical Trial Audits
- Different types of GCP audit and how audit programmes are developed using a risk-based approach - Applying GCP principles to audit planning
16:30 Summary
- Discussion, Questions & Answers - Workshop set-up and scenarios for Day 2 - Preparation by delegates for Day 2
17:15 End of Day 1
Tuesday 13 December 2022
9:00 Opening of the Training
9:15 Welcome & Recap from Day 1
- Discussion, Questions & Answers - Workshop set-up and scenarios for Day 2
9:45 Audit Planning Workshop (1)
Delegates will have the opportunity to plan an example GCP audit, to be conducted either face-to-face or remotely, using case studies and present their plan for discussion and development
11:15 Workshop Feedback
Delegates share their plans and critically evaluate the strengths and weaknesses of their audit process
12:00 Lunch
12:45 Audit Planning and Computerised Systems
- Overview of common computerised systems used in clinical trials - Points to Consider when planning GCP audits
13:30 Data Integrity in Audit Practice
- An introduction to data integrity applied to clinical trial audits - Regulatory perspectives on data integrity
14:30 Audit Planning Workshop (2)
- Consideration of electronic tools and systems, GCP & data integrity in GCP audits - Common GCP Computerised System examples – delegates will have the opportunity to propose methods for review of common GCP electronic systems - Group feedback and discussion on systems and methods
16:45 Course Summary & MCQ Test
17:30 End of the Training