- Are you in compliance with the FDA Corrective and Preventive Action (CAPA) requirements for medical devices?
- Do you know how to identify root cause?
The cost of regulatory noncompliance remediation is significantly greater than the cost of compliance.
By attending this two day intensive seminar on CAPA, participants will:
- Gain detailed knowledge of CAPA.
- Learn how to ensure that their CAPA process is adequate and effective.
- Understand and implement proven methods of problem solving to identify root causes.
- Learn proven, thorough, and efficient methods of problem solving to improve the performance of their current system and ensure regulatory compliance.
This program will include a “pre-test” to be reviewed on Day 1 of the program and a “homework” assignment to be completed on the evening of Day 1.
Upon completing this course participants will:
- Understand both corrective and preventive actions: definitions, differences, similarities
- Understand how FDA inspects CAPA
- Create a “closed loop” CAPA program
- Learn root cause analysis through the use of problem-solving tools and methodologies
- Evaluate the effectiveness, suitability, and adaptability of implemented solutions/corrective actions
- Understand where an issue can be localized or must be evaluated for systemic effect
- Prioritize using risk assessment methodologies
- Understand where companies miss the mark in triggering, investigating, and executing CAPAs
Who will Benefit:
This course is designed for personnel responsible for performing, maintaining, and improving the organization’s CAPA program in compliance with 21 CFR 820.100 (Subpart J – Corrective and Preventive Action). The following personnel will benefit from the course:
- Quality Managers and Professionals
- Regulatory Managers and Professionals
- Compliance Managers and Professionals
- Production Management
- Manufacturing Engineers
- Process Owners
- Quality Engineers
- Quality Auditors
- Document Control Personnel
- Legal Professionals
Since 2010, the FDA’s findings of medical device manufacturers Quality System Regulation (QSR) deficiencies have shown that Corrective and Preventive Action (CAPA), one of the seven subsystems under the Quality System Inspection Technique (QSIT) methodology is by far the most prevalent, accounting for almost one-third of cited violations; a significant number of those citations have led to the issuance of Warning Letters. The expectation of the FDA is the identification of the root cause leading to the issue, its effective elimination, and monitoring to ensure that the actions taken were effective.
The average cost of a Warning Letter remediation effort is estimated at $750,000 to correct the identified deficiencies and includes additional resources for consultants, personnel, remediation of legacy records, etc. This cost estimate does not even include the ramifications of product recalls or holds, cost of not going to market with a new device, or delays in FDA 510(k) or PMA processing as a result of a Warning Letter, and poor publicity.