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."

• 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 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)

His assets :

• Presenter, speaker, (SAS Stockholm; Allan Lloyd Amsterdam; DIA data Madrid, DIA Barcelona, ERES Roche)
• Vendor Audits and Quality Reviews
• Concepts for the quality management system, CAPA system, Change management, ISO9001:2015
• Process management (Policies, SOP’s, SA entries, System Validation); Risk assessment and management; CAPA plans (create, review and approval); Equipment (inventories, qualification, validation); Documentation, Templates; Training (GxP, CSV, CAPA, Company rules, Project management methodology)

Variety of work :

• IT projects (from quality assurance and validation to access concept and security)
• Lab projects (pathology, CPU, DNA, RNA)
• Clinical trial teams quality assurance (Report validation, endpoint adjudication, Web sites)
• CRO’s (clinical research organization)