Description

Quality Assurance Related Courses

This 1-day course on System Audit will allow you:

  • Understanding what a system audit is, the advantages and disadvantages of conducting them
  • Engaging with your stakeholders; ensuring stakeholder buy-in and support
  • Deciding which systems to audit
  • Understanding the system/process; Process mapping and its benefits in developing system audits
  • Scoping the system audit; what to include and how far to go
  • Conducting and reporting a system audit

The course includes cases studies, short exercises and a final evaluation to encourage understanding.

System audits are a valuable addition to your company audit program.  In the new ICH GCP E6 R2 world, a risk-based approach to clinical trials including audits is essential.  System audits are designed to seek out those high-risk weaknesses and failures of the process and associated systems.  When performed well these audits add tremendous value in identifying systematic risks and issues, and form part of the risk management and monitoring activities of an organisation.

The conduct of system audits can be challenging as they require;

  • Comprehensive evidence in support of the measurement of compliance, effectiveness and performance of the process/system
  • If the audit examines complex activities, then obtaining and interpreting the evidence can be difficult and may require technical expertise for specialised areas.
  • No reporting standards exist for a system-based audit because each audit has specific requirements and results.

Clinical auditors will need to have the skills and confidence to embrace these challenges and understand the concept of system audits and their application in the delivery of high quality audits.

This course provides you with the grounding that will allow you to become familiar with the key stages in preparing, developing, conducting and reporting a system audit.

Course time
09h00-17h00
Who should attend

Clinical auditors, other quality professionals and anyone with a professional interest in Clinical Trial System Audits.

Programme highlights
  • Defining system audits
  • Regulations: ICH-GCP E6
  • Objective assessment of the advantages and disadvantages of system audits
  • Determination of key stakeholders
  • Stakeholder engagement
  • Risk based approach to system selection for audit
  • Process mapping exercise
  • Scoping the system audit appropriately
  • The system audit plan
  • Defining the audit roles and responsibilities
  • How to conduct the system audit
  • How to write system audit reports that generate action
Learning Objectives
  • Understanding the advantages and disadvantages of system audits
  • Understanding how to position these audits for success
  • Understanding how to plan conduct and report a system audit

Competencies

This course covers competencies that are part of the ECCRT Competency Framework:

  • Clinical Studies Operations (GCPs or ISO 14155) (2)
  • Study and Site Management (1)
  • Data Management and Informatics (1)

Book a course

Date Lang Location
 
Proceeding your application may take up to 24 working hours. In case of question, contact campus@eccrt.com.
1 250,00 € excl. VAT (if applicable)

Testimonials

Susan Holt
June 2018
Company
SGS

Using the afternoon session to apply what we learned in the morning.  Using a real-life example to practice and obtaining valuable input and guidance from Cathy as to how to proceed with our next system audit - Thank you Cathy for a productive day of hands-on training and sharing your personal experiences as an auditor and quality assurance expert.