Mishandling deviations and failing to investigate them correctly can lead to serious compliance problems. Hence, regulators can shut-down your operation in a blink of an eye. Additionally, not addressing deviation properly leads to reoccurring issues, which waste time and are a killer of productivity. Therefore, each GMP professional must know the correct framework to deal with such issues quickly and effectively.
This interactive workshop covers the essential elements for investigating issues that arise within a product’s life cycle. It includes the manufacturing, testing, control, and distribution of medicinal products.
It provides a best practice framework for analyzing deviations and implementing corrective actions. Additionally, it teaches you approaches to apply to all relevant areas of the product life cycle and supply chain, which includes:
- Product quality complaints,
- audit findings,
- laboratory Out of Specification / Out of Trend results
The approaches will help you:
- document deviations quicker and more effectively,
- drive continual improvement to your systems,
- reduce the number of reoccurring deviations,
- minimize the number of overdue deviations in the system
- become more effective and reduce stress.