Elements of a Corrective and Preventive Action (CAPA) Program and Uses of CAPA Data
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Course Description:
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 non-conformances and potential non-conformances enables both regulatory compliance and cost savings. This session 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 explained.
This webinar will identify the most common elements identified as deficient by FDA, and provide recommendations for how to provide clear, concise documentation to assure FDA your firm has addressed these in your quality system. This webinar also provides recommended forms to assure that in addition to being able to illustrate compliance, your firm's CAPA system is useful and meaningful.
Why should you Attend?
This webinar will identify the most common elements identified as deficient by FDA, and provide recommendations for how to provide clear, concise documentation to assure FDA your firm has addressed these in your quality system. This webinar also provides recommended forms to assure that in addition to being able to illustrate compliance, your firm's CAPA system is useful and meaningful.
Areas Covered:
- Regulatory Requirements 1) FDA QSR & 2) ISO 13485
- Elements of a cross-procedural CAPA program
- Applications of CAPA
- CAPA Data, and best practices for its use
- Application of risk management to CAPA program
Who will benefit?
This webinar will provide valuable assistance to all regulated companies, since a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
- QA management
- CAPA coordinator
- Regulatory Affairs management
- Executive management
- Consultants
- Quality system auditors
- Quality and Regulatory Network Group
- Corrective and Preventive Action Group
- Medical Devices Group
- American Society for Quality
- Regulatory Affairs Professional Society
Those individuals who require a more in depth understanding of corrective and preventive actions, or those who are or will be undertaking root cause investigation.
Registration Options
Tags
FDA, CAPA, Corrective and Preventive Action, Medical Device, Regulatory Compliance, FDA QSR, ISO 13485, Regulatory Affairs, Quality System, Regulatory Network, Quality, Regulatory Affairs, Diagnostic, Pharmaceutical, Biologics
Speaker Details
Jeff Kasoff
FDA Speaker, Quality and Regulatory Consultant
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 start-up 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.
Refund Policy
Participants/Registrants for our live events, may cancel up to 72 hours prior to the start of the live session and ComplianceTrain will issue a letter of credit to be used towards any of ComplianceTrain's future events. The letter of credit will be valid for 12 months.
ComplianceTrain will process refund in cases where the event has been cancelled and is not rescheduled within 90 days from the original scheduled date of the webinar. In case if a live webinar is cancelled, participants/registrants may choose between recorded version of the course or a refund. Refunds will not be processed to participants who do not show up for the webinar. A webinar may be cancelled due to unavoidable circumstances, participants will be notified 24 hours before the scheduled start of the event. Contact us via email: admin@ComplianceTrain.com
