Course Descriptor

This course in collaboration with ERA Sciences provides an introduction to Data Reliability with an emphasis placed on Application Lifecycle Management (ALM). The impact of GAMP 5 Revision 2 and Computer Software Assurance (CSA) as it applies to validation will inform classroom discussions and how efforts are becoming increasingly commensurate with risk. 

And in case you are unsure of what ALM means to your GxP processes and records – ‘Ensuring a system remains ‘fit for purpose’ to meet the intended business need and deliver reliable data’

We examine what happens when you cannot gain access to your data, cannot read it or cannot migrate it to a newer application? and what regulatory observations and findings continue to highlight poor ALM.
We look at how poor Application Lifecycle management can just creep up on you (and if there were any warning signs?)
You will learn to identify during work sessions how

  • software with limited/no updates cannot sustain business processes
  • outdated software is considered by vendors ‘unmaintained’
  • software develops a bug and how it impacts data records and results
  • software can fall prey to cyber-attacks on the company network when patching is ‘patchy’
  • how a move from on premise to cloud based solutions needs to consider ALM of each solution and its risk to data/records

The final course work session will help you to identify and map out the points where
an application becomes not fit for purpose and ultimately leads to unreliable data.

Data Reliability and Application Lifecycle Management (ALM) in Collaboration with ERA Sciences

SKU: Introduction-to-Data-Reliability-and-Integrity-1-2 Category:

595.00

Dates:
  • 13/02/2023

    14 Places Remaining

Fee:
€595
Suitable for:

New to the organisation or requiring more advanced topic understanding in relation to GxP applications lifecycle management. QA, CSV, Manufacturing, IT

Who should attend

New to the organisation or requiring more advanced topic understanding in relation to GxP applications lifecycle management. QA, CSV, Manufacturing, IT

Learning outcomes

You will learn to identify during work sessions how

  • software with limited/no updates cannot sustain business processes
  • outdated software is considered by vendors ‘unmaintained’
  • software develops a bug and how it impacts data records and results
  • software can fall prey to cyber-attacks on the company network when patching is ‘patchy’
  • how a move from on premise to cloud based solutions needs to consider ALM of each solution and its risk to data/records

The final course work session will help you to identify and map out the points where
an application becomes not fit for purpose and ultimately leads to unreliable data.

Assessment

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

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