- Manufacturing operations
- Investigations
- Regulatory audits
- Product surveillance, i.e, complaints and adverse events
DBT has extensive experience in the development and implementation of effective corrective action procedures that represent the culmination of a number of supporting structures and input:
- Conducting proper investigations
- Identifying sources of CAPA
- Determining the corrective or preventive actions
- Validating the actions prior to implementing them
- Determining the effectiveness of the actions
CAPA represents a key area that FDA concentrates upon because it goes right to the heart of product problems. Is your company prepared?