Course Descriptor

This course in collaboration with ERA Sciences provides an introduction to Data Reliability with an emphasis placed on Data Integrity, a key enabler of reliable data.
Training material will include Data Integrity core concepts such as ALCOA+, Data and
Records Lifecycle Management, and impact of poor data practices.

This course is hands-on with case studies and scenarios challenging the learner to
understand:

  • how actions and activities can make/break data reliability efforts
  • how to examine systems and records in the NIBRT laboratory /or
    manufacturing suite
  • how to assess data integrity controls

Recurring and emerging inspection observation examples including FDA Warning
letters and 483s will be discussed, and how risks associated with data often occur
but could have been avoided. References to 21 CFR part 11 and Annex 11 will be
included to enhance understanding of the regulatory landscape. Management of raw
data and original records will be described across the data lifecycle with some
practical solutions, and the learner identifying if ALCOA+ attributes are delivered.
As technology solutions continue to expand and improve more traditional manual
processes we will also examine the challenges associated with the introduction of
new systems/technology and how these must comply with existing regulations.
The importance of a Data Integrity culture of excellence will be shown with examples
of how to escalate potential issues before they can negatively impact the patient.

Data Reliability and Integrity in Collaboration with ERA Sciences

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

595.00

Dates:
  • 08/02/2023

    15 Places Remaining

Fee:
€595
Suitable for:

New to the organisation or requiring refresher data integrity training with an understanding of the current regulatory landscape.  QA, QC, R&D, Validation, Metrology, C&Q, QMS, Manufacturing, Supply Chain, IT.

Who should attend

New to the organisation or requiring refresher data integrity training with an understanding of the current regulatory landscape.  QA, QC, R&D, Validation, Metrology, C&Q, QMS, Manufacturing, Supply Chain, IT.

Learning outcomes

This course is hands-on with case studies and scenarios challenging the learner to
understand:

  • how actions and activities can make/break data reliability efforts
  • how to examine systems and records in the NIBRT laboratory /or
    manufacturing suite
  • how to assess data integrity controls

Assessment

There will be multiple test yourself opportunities to benchmark your learning.

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