One-day training on Deviation Management, including Root-Cause Analysis, Impact Assessment and Corrective and Preventive Actions (CAPAs).
Despite all the preparations, unforeseen problems sometimes arise. In the pharmaceutical industry, you are expected to investigate why mistakes happen and how they can be prevented in the future.
Good research is not easy. Often a root-cause analysis is time-consuming and it is a challenge to get to the real root cause. Common challenges with this are:
- What are good corrective and preventive actions?
- How do I make sure nothing is overlooked?
- How do I monitor timelines?
These are just a few examples of the challenges encountered in daily practice when performing deviation management.
Deviation management contributes to improving quality but can cause unnecessary loss of time and frustration for many companies. It doesn't have to be that way!
In this training, you will learn what the expectations are from the GMP/GDP regarding Deviations and CAPA management. The preparation of clear workflows is also discussed, but also how good impact assessments and root-cause investigations can be carried out.
Determining effective corrective and preventive actions (CAPAs) with realistic timelines and preventing exceedances of these timelines is also discussed in detail.
A practical training in which examples and tools are given to improve your Deviation and CAPA process.
