Reacting to deviations that occur within a process is one thing, but setting practical corrective measures is another. Failing to implement effective corrective and preventive actions (CAPAs) can lead to serious compliance problems. Consequently, it may give regulators a free hand to shut-down your operation without warning. Additionally, not implementing the right CAPAs will lead to repeating deviations will waste time, money, harm KPIs, and cause stress daily.
This course covers the essential elements for managing issues that arise within a product’s lifecycle. It includes the manufacturing, testing, control, and distribution of medicinal products. Also, it provides a best practice framework for managing your reactions to issues that occurred during the life-cycle process.
The workshop will allow you to align yourself with all the requirements of ICH Q10 and ISO 9001:2015 regarding events investigation.
By the end of the workshop, you will know how to create effective CAPAs, which will reduce the number of reoccurring deviations and minimize overdue deviations in the systems. As a result, you will save a lot of time, money, improve KPI’s, and have less stress in your daily routine.