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.
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."
Willi Ramseier is the pragmatic system thinker, project management skills, risk management know-how, expertise in CAPA system and QMS (quality management system), a consultant for general quality issues (especially for start-ups)
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