Course description
Deviation & CAPA Management
This one-day training course 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
Upcoming start dates
Suitability - 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
Training Course Content
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 course, 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.
Course delivery details
If you choose our virtual learning option, training will be delivered via a combination of an instructor-led virtual classroom and self-paced learning online. Full details will be sent to you following registration.
All of NSF's pharmaceutical training courses can be brought on-site, tailored to your key concerns and delivered at a time that suits you.
Why choose NSF International, Health Sciences
Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course
Provided expert health sciences training for over 30 years
More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider
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Expenses
Discounts
Discounts offered to NHS staff, regulators and charities.