CAPA: A Critical Quality System Requirement

There has been several form 483’s and warning letters being issued to companies by the FDA as it relates to CAPA investigation because of insufficient or incomplete quality systems procedures applicable to corrective action and preventative action programs (CAPA). Addressing an FDA form 483 with findings associated with CAPA systems must be performed adequately, complete and must provide enough details within the CAPA procedures to ensure an effective CAPA investigational procedure. All failure, deviation or out of specification investigations must be adequately documented, corrected, prevented and checked for corrective action effectiveness through the use of a compliant CAPA investigational system and program. The result of a product investigation impacts the quality of the cGMP manufactured product label claim, to avoid it from being termed ‘adulterated” by the FDA which may result in product recalls, complaint and further actions by the FDA.

This 90-minute accredited training will benefit manufacturers of cGMP products in designing an effective, robust and compliant CAPA investigation system in order to avoid FDA or other regulatory bodies’ inspection findings in these areas. It will also be a great resource to Quality Assurance, Manufacturing, Regulatory Affairs and Quality Control personnel and management within the Pharmaceutical, Biotechnology and Medical Device companies.