Course Descriptor

This course in collaboration with ERA Sciences provides an introduction to Data Reliability with an emphasis placed on Risk Management.

When discussing risk in relation to data, which includes both paper based records and automation of ‘GxP’ processes resulting in electronic records, a common pitfall is to get the context wrong. For example, “What is the risk of this machine failing?” has an unclear context and does not directly link back to the patient.
Inspection observations continue to cite ‘ lack of appropriate measures’ …, taken when issues relating to QC data are identified but the product has already been released. Risk assessments associated with such critical issues need a focussed and adequate approach to mitigate further patient risk – we will help to walk you through this process.
In this course we will also explore what a catastrophic event means to Patient Health, Product Quality and Data Reliability and discuss some examples of realised risks with unbounded downsides.
We will use practical examples to understand risk subjectivity and how to optimise creative inputs for best data outcomes whilst effectively managing group biases.

Learners will have to complete tasks and be part of

  • small team risk sprint workshop
  • examine ICH Q9 R1 and the Risk Management Lifecycle
    ○ how to leverage formality
    ○ how to manage subjectivity
  • determine risk management and oversight controls for data and automation

Typical team risk challenges examine how data must be reviewed by QA departments, including: computerised records stored in the cloud/shared drives.

The use of data maps to identify data at risk will be showcased with learners getting hands-on experience of uncovering risks in a challenging cross functional setting.

Data Reliability and Risk Management in Collaboration with ERA Sciences

SKU: Introduction-to-Data-Reliability-and-Integrity-1-1 Category:

595.00

Dates:
  • 09/02/2023

    14 Places Remaining

Fee:
€595
Suitable for:

New to the organisation or part of the site QRM team with an understanding of the current regulatory landscape. QA, IT, Validation, QRM champions.

Who should attend

New to the organisation or part of the site QRM team with an understanding of the current regulatory landscape. QA, IT, Validation, QRM champions.

Learning outcomes

In this course we will also explore what a catastrophic event means to Patient Health, Product Quality and Data Reliability and discuss some examples of realised risks with unbounded downsides.

We will use practical examples to understand risk subjectivity and how to optimise
creative inputs for best data outcomes whilst effectively managing group biases.

Learners will have to complete tasks and be part of

  • small team risk sprint workshop
  • examine ICH Q9 R1 and the Risk Management Lifecycle
    ○ how to leverage formality
    ○ how to manage subjectivity
  • determine risk management and oversight controls for data and automation

Assessment

There will be multiple test yourself opportunities and a short assessment to benchmark your learning.

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