Learn about the Background of CAPA to Understand why the FDA, EMEA and ISO9001
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Add to gcalThis webinar provides a basic grounding of CAPA, its origins, use, and the connection to today’s FDA’s 21 CFR Part 820 Subpart J-Corrective and Preventive Action.
This webinar provides a basic grounding of CAPA, its origins, use, and the connection to today’s FDA’s 21 CFR Part 820 Subpart J-Corrective and Preventive Action. A solid understanding of CA (Corrective Action) and PA (Preventive Action) is essential for maintaining a high level of quality throughout any company. The control mechanisms for medical devices -- from heart valves to sticking plasters to artificial hips – are being tightened. Companies are asked to implement a product monitoring system that records product-specific complaints and immediately implements corrective action, as well as, actions to prevent recurrence and guarantee future-safe performance.
Your CAPA system should not be a dutiful exercise in regulatory compliance but rather an integral part of your company’s risk mitigation for future product or service development, marketing, and sales. CAPA provides a structured framework for compliant and increased quality processes and procedures in industries ranging from pharmaceuticals to medical devices to manufacturing and tech. Dr. Deming: “A system must be managed.” “Without an aim, there is no system. The aim must include plans for the future.” “To successfully respond to the myriad of changes that shake the world, transformation into a new style of management is required."
- Overview and Definitions
- The history of CAPA – this background knowledge provides the basis for PA
- Learn to understand: Title 21, Chapter I, Subchapter H, Part 820, Subpart J-CAPA, §820.100, (a), (1)
- Why there is a CA and a PA, and about the Known and the Unknown
- Learn who and where you should implement a CAPA System
- Understand the criticality of PA in a computerized environment
- Common mistakes and today's problems
- Best practices, and where to find them
- Questions
- Management
- Business system/application owner
- Process developer
- Risk managers and analysts
- Change-management owners
- QA, QC managers, and analysts
- IT, Information technology analysts
- Computer System Validation specialists
- Start-Ups
Willi Ramseier is currently the owner and director of QVRAM GmbH of Basel, Switzerland. As an expert in quality assurance, system validation, risk awareness, and management, Ramseier is a reputed trainer, mentor, and quality compliance officer.
Having worked at Hoffman-La Roche, he now consults across Europe as a process-validation expert at Synthes-DePuy-Johnston & Johnston Switzerland, a quality consultant and CSV advisor, and GxP Workshop Trainer for a CROs in Cologne and Dresden. He also is a teacher and lead auditor for ISO 9001:2015.
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