Course Overview

This workshop is designed to re-evaluate your process – use risk to your advantage and make sure the effort of you and your team is focused where it should be placed; where potential patient impact is greatest. Learn what a ‘good’ deviation system and deviation report looks like. Can your site benefit from a clear standard for the content of deviations? Reduce the rejection rate by helping everyone understand what ‘good’ looks like.

Why You Should Attend

The typical failings in deviation systems are:

  • Poor recognition and reporting of events
    • Reflecting badly chosen performance measures, or lack of ownership of the system outside QA
  • Failure to classify events on the basis of significance
    •  Is everything handled the same way and do potential major (or critical) deviations get overlooked
  • Lack of rigor in investigation of cause
    • So true cause(s) and contributing factors are missed and the same deviations recur, again and again

This practical workshop looks to risk-based processes, identifying the most important events to fully address and effectively identifying those of less significance which can be handled in a less comprehensive manner. This will ultimately save you time and valuable effort ensuring the system adds value not just bureaucracy. 

The course identifies a baseline standard which you can adapt for your operation and agree with all the affected teams; production, engineering, laboratories and quality assurance and so reduce the wasted re-work of the reports!
 

Tools/Skills You Will Leave With

This course is not just about how to conduct a root cause investigation (although that is covered) - it is much, much more:

  • Learn to efficiently triage or prioritize incidents based on potential risk
  • Handle incidents according to that potential risk and target your restricted resources where they will add greatest value
  • Helps you conduct a thorough investigation – before you jump to a conclusion!
  • Set an expectation that events will be handled in a timely manner.  Helps you create processes which enable you to report, investigate and resolve deviation incidents in hours not weeks
  • Identify the needs for the written report so that years after the incident you can accurately reconstruct the history of the event from the report and are not left guessing in front of a frustrated inspector

Who Would Benefit

This course is ideal for you if:

  • You are in QA and own the site system
  • You or your team are having to complete deviations and need help with how to best approach the investigation and reporting
  • You have had issues with your deviations raised in your latest (and previous) inspections – issues that have not been investigated fully or repeat issues

Identify:

  • What is expected of the deviation system?
  • What does ‘good’ look like for the system?
  • What does ‘good’ look like for the report?

Come to this one-day workshop and stay for the two day Human Error Prevention workshop which follows and addresses the causes and resolution of events.

Facilitated By

Erika Notman - Erika has vast experience of deviation and CAPA systems as an operations QP and operations manager. A microbiologist by profession, Erika has used all of the tools and techniques covered on the course, successfully helping companies prevent errors and mistakes by implementing very simple, proven to work solutions. 

Workshop Fees

Course cost (excluding VAT)  £695.00

DISCOUNTS AVAILABLE

Early bird and multiple delegate booking discounts available. Discounts also offered to NHS staff, regulators and charities - contact us for details.

Have a question or want to book a place? Contact pharmacourses@nsf.org - you can also register online by clicking below.

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