Corso Live Webinar Registrato- How FDA Trains Its Investigators to Review CAPA, and Best Practices for Preparation [ENG]
1 h + 10 min. Question Time
Areas Covered in the seminar
Why You Should attend
Year after year, CAPA is the subsystem cited most frequently during FDA inspections. A robust Corrective and Preventive Action (CAPA) program is of the utmost importance to an FDA-regulated manufacturer. A system that identifies and eliminates nonconformances and potential nonconformances enables both regulatory compliance and cost savings. During an inspection, FDA personnel will take a great deal of time reviewing your company’s CAPA system. The best way to assure compliance is to be well versed in the method of questioning used by the FDA inspector, and prepare accordingly.
This session will discuss all the documents used by FDA to train their inspectors to review your CAPA system, some of which you may not be familiar with. Also contained in this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document in your preparation.
A chi è rivolto il Corso:
Requisiti per il rilascio dell’attestato:
Il partecipante dovrà assistere all’intero corso e dovrà superare con esito positivo un test finale. Il certificato verrà rilasciato con un punteggio conseguito superiore all’80%. Il certificato firmato dal trainer verrà spedito via email e se richiesto anche via posta.
Il programma Online include:
Corso presentato dal Trainer Americano Jeff Kasoff:
Jeff Kasoff, RAC, CMQ/OE has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff has the following certifications: Manager of Quality and Organizational Excellence certification from ASQ, Regulatory Affairs Certification from RAPS, and Lean Black Belt from IIE.