Corrective and Preventive Action (CAPA) Process for Medical Devices

CAPA (Corrective and Preventive Action) is the most frequently cited process in FDA 483 and Warning letters. In 2014, the FDA issued 360 483s against the CAPA system. The major deficiencies were:

• Inadequate procedures
• Inadequate effectiveness
• Inadequate investigations
• Timeliness

Identifying the key steps to an effective CAPA, this course leads participates through practical steps from issue identification to verification of effectiveness. Identifying pitfalls and working real case examples with an emphasis on root cause analysis, this course prepares both those new to CAPA and CAPA veterans for the ever increasing challenges of medical device CAPA compliance.

Erin E Wujek is the Principal Consultant and Managing Member of BioMed Solutions LLC. There, she is a consultant to the Medical Device industry and provides services in all areas of the Quality System Regulations including CAPA, Complaint Handling, Nonconforming product and Process Validation – including the integration of new CAPA systems for the stakeholders.

Prior to her consulting work, Erin served as Sr. Quality Engineer, Sr. Manufacturing Engineer and a Research Engineer for large Medical Device companies throughout the country. She was employed in the Research and Development department of Arthrex, Inc, where she specialized in prototype testing and design of new and innovative arthroscopic devices and procedures in Orthopaedic sports medicine. This was followed by specializing in failure analysis and reliability of Orthopaedic implants as well as Dental power instruments while employed by ConMed Linvatec. While at Teleflex Medical and Zimmer she received a firm understanding of manufacturing processes, process validation, quality improvements, Kaizen and other Lean manufacturing skills. At Cook Endoscopy, she specialize in Risk Management, CAPA root cause analysis and new product development activities.