Corrective and Preventive Action Training Overview
This training session online will discuss the importance, requirements, and elements of a CAPA program, as well as describing the uses of CAPA data. Additionally, the application of risk management to a CAPA program will be reviewed, and a specific risk management system detailed.
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 a medical device manufacturer. A system that identifies and eliminates nonconformances and potential nonconformances enables both regulatory compliance and cost savings.
This session will cover all the items listed above, and more. If you want to improve your CAPA system, you cannot afford to miss this.
Webinar Includes : All the training handouts , certificate ,Q/A and 6 hrs Live Webinar
- Applicable Regulations, INCLUDING ISO13485:2016 CHANGES
- Contents of Procedure(s)
- Quality Data and Recommended Practices for Inclusion in CAPA
- Elements of a CAPA program
- Detection of nonconformance
- Identification of cause (Investigation)
- Review of Investigation
- Determination of Corrective/Preventive Action
- Performance of Corrective/Preventive Action
- Implementation of Corrective/Preventive Action
- Effectiveness of Corrective Action
Who will benefit from this Corrective and Preventive Action Training
This webinar will provide valuable assistance to all regulated companies, a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
- CAPA Coordinators
- Executive Management
- R&D management
- Regulatory management
- QA management
- Quality system auditors
Jeff Kasoff, RAC, CMQ/OE, LBB
Regulatory Compliance and Quality Assurance ► FDA QSR, ISO 13485/9001 ► Operational Excellence -Remote Consultations
York, Pennsylvania, United States
Jeff Kasoff, RAC, CMQ/OE, LBB, 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.
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