Corrective Action / Preventive Action
Last year alone, nearly 200 Warning Letters were issued to medical device and pharmaceutical firms for QS/GMP deficiencies, with CAPA being the most prevelant subsystem noted.
Can your CAPA System stand up to regulatory scrutiny?
Our world-class CAPA training and CAPA consulting solutions help address the following key quality areas:
- Risk Assessments
- Investigator Toolkit
- Implementation
- Effectiveness Checking
PathWise focuses on a solution-based approach to solving client issues. When training is the appropriate solution, we help simplify the necessary concepts and processes, ensuring a quality system program that conforms to industry and regulatory standards. Our instructors utilize a how-to approach to learning, using a blended application of classroom exercise and real-life experience.
Whether it is remediation resulting from regulatory findings, (Form 483 or Warning Letter) or the objective is to improve quality and compliance before that happens, PathWise will work with your organization to deliver solutions. Our consultants go beyond prescriptive suggestions- we work in tandem with clients to create new systems or write new procedures.
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Learn how to prepare your CAPA system for an FDA Inspection using our FDA Inspection Flow Diagram.
Why do you need CAPA?
The FDA defines CAPA as one of the most important quality system elements. The purpose of the corrective and preventive action subsystem is to collect and analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their occurence or recurrence.
Critical activities within CAPA are: verifying or validating corrective and preventive actions, communicating corrective and preventive action activities to responsible people, providing relevant information for management review, and documenting these activities are essential in dealing effectively with product and quality problems.
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