About This Workshop

This one-day workshop is designed to re-evaluate your deviation process by using risk to your advantage, in addition to corrective and preventive actions (CAPAs). Going through deviation and CAPA management training makes sure you and your team’s efforts are focused where they should be on; where potential patient impact is greatest.

Our objective is to help you:

  • Identify what is expected of the deviation system
  • Learn what a good deviation system and deviation report look like
  • Ensure your worksite benefits from a clear standard for the content of deviations
  • Minimize dead time in the review process by helping everyone understand what “good” looks like

After the workshop, stay for a human error prevention workshop that addresses the causes and resolution of events.

Key Learning Objectives

This deviation and CAPA management training course is about more than conducting a root cause investigation (although that is covered). At the end of the workshop, you will be able 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
  • Understand how to conduct a thorough investigation before jumping to conclusions
  • Set an expectation that events are handled in a timely manner and create processes that 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

The course identifies a baseline standard that can be adapted for your operation and agreed with all the affected teams, e.g. production, engineering, laboratories and quality assurance.

Why You Should Attend

Reduce wasted re-work in your deviation reports. This practical deviation management workshop looks at risk-based processes, singling out the most important events that need to be fully addressed while effectively identifying those of less significance that can be handled in a less comprehensive manner. The goal is to ultimately save you time and valuable effort by ensuring the system adds value, not bureaucracy.

The typical failings in deviation systems are:

  • Poor recognition and reporting of events
    • This can reflect badly chosen performance measures or lack of ownership of the system outside quality assurance (QA).
  • Failure to classify events on the basis of significance
    • If everything is handled the same way, you are wasting time and energy.
    • Potential major (or critical) deviations must be addressed in full while risk events are lowered and managed in a more appropriate manner to direct energy where it is needed the most.
  • Lack of rigor in investigation of root cause
    • True cause(s) and contributing factors are often missed and the same deviations recur again and again.

Who Should Attend

This course is ideal if you or your team:

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

Course Tutor

Course tutors will be selected from the following:

Catherine Kay - Catherine has extensive pharmaceutical operations management, technical and QA experience spanning more than 23 years, gained working for a major international pharmaceutical organization, a start-up manufacturing organization and, most recently, a contract manufacturing organization in a corporate operations role. Catherine is passionate about developing people and creating learning organizations, with continuous improvement embedded in daily operations.

Peter Savin - Peter has over 40 years’ experience in the pharmaceutical industry, including a senior management career in multinational pharmaceutical companies, and was formerly Vice President, Global QA for GSK. He has experience in warning letter and consent decree remediation activities and is passionate about preventing the typical errors that organizations make when in this situation. He is also the editor of GMP Review.