We are very excited about our new medical device course and how it responds to FDA findings with CAPA systems...
Malvern, PA (PRWEB) September 16, 2015
The Center for Professional Innovation and Education (CfPIE), the global leader of technical training across the life sciences industry, has launched a new two-day course on the Corrective and Preventive Action (CAPA) Process for Medical Devices. The course gives attendees an in-depth understanding of CAPA system elements and defines what is required for compliance with the FDA's Quality System regulation.
CAPA is the most frequently cited process in FDA 483 and Warning letters. In 2014, the FDA issued 360 483s against the CAPA system. They found deficiencies in procedures, effectiveness, investigations, and timeliness.
Key topic areas of this course include:
- Key steps to an effective CAPA system from issue identification to verification
- Common pitfalls to avoid
- Real case examples with an emphasis on root cause analysis
- Implementation plans and effective monitoring
- FDA perspectives and expectations
- CAPA monitoring exercises
The CAPA Process course is led by Erin E. Wujek, an industry-active course instructor at CfPIE and principal consultant and managing member of BioMed Solutions that serves the medical device industry. Wujek specializes in all areas of the Quality System Regulations including CAPA, Complaint Handling, Nonconforming product and Process Validation, and the integration of new CAPA systems for the stakeholders.
“We are very excited about our new medical device course and how it responds to FDA findings with CAPA systems,” says Mark Mazzie, CEO at CfPIE. “Our industry-active instruction and dynamic learning format will prepare participants to be informed and effective for their organizations.”
Learn more about the learning objectives and who should attend this CAPA Process course.
Certification tracks available for this course include: Certified Medical Device Compliance Professional (CMDCP), Global Regulatory Affairs Compliance Professional (GRACP), and Quality System Regulation (QSR) Certified Compliance Professional (QSRCP).
CfPIE can tailor the CAPA Process course for on-site training offering convenience to multiple employees and a consistent experience with company-specific content.
The Center for Professional Innovation and Education (CfPIE) is the global leader in quality training for pharma/biotech, medical device, and skin/cosmetics segments of the Life Sciences industry. Classroom and custom on-site formats, and certification programs help improve personal skills, maintain regulatory compliance, and advance careers. Small class sizes and industry-active course directors promote a dynamic learning environment with excellent student-to-teacher interaction. More information: http://www.cfpie.com