Assessing risk in nonconformities, conducting investigations, implementing corrective and preventive actions and effectively documenting them all; in order to meet FDA expectations and your organization’s needs can seem like a Herculean feat. Anyone who has ever conducted some, or all, of these activities understands these challenges. It is very important to recognize the relationship of the different steps in the investigation phase, the key statements in each phase, and the relationships of those key statements. Crafting those statements well will improve the quality of each activity as well as the Investigation Report.
- 5 Hours
- Region: Global