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Webinar Language: English


This Process Validation Requirements webinar will review process validation basics, with emphasis on looking beyond compliance towards achieving a robust process. Review of process validation basics, with emphasis on looking beyond compliance towards achieving a robust process. When used as intended, process validation can provide increased process reliability, improved yields, and reduced operating expenses.

Areas Covered in the Session :

  • Global Harmonization Task Force requirements (includes FDA and ISO)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Design Qualification
  • Facilities and utilities
  • Strategies for achieving a robust and reliable process.
  • Typical process validation protocols

Who Should Attend:

  • Research and Development Departments
  • Engineering Departments
  • Quality Departments
  • Manufacturing Departments
  • Operations Departments
  • Production Departments
  • Document Control Professionals
  • Device Development Teams
  • Quality Auditors
  • Personnel involved in Verification and Validation planning, execution and documentation for devices

Webinar Language: Español


Este seminario web sobre Requisitos de Validación de Procesos revisará los conceptos básicos de la validación de procesos, haciendo hincapié en mirar más allá del cumplimiento para lograr un proceso sólido. Se analizarán los fundamentos de la validación de procesos, con énfasis en buscar la excelencia operativa más allá del cumplimiento para lograr un proceso sólido. Cuando se utiliza según lo previsto, la validación de procesos puede proporcionar una mayor confiabilidad del proceso, mejores rendimientos y menores gastos operativos.

Temas cubiertos en la sesión:

  • Requisitos del Grupo de Armonización Global (incluye FDA e ISO)
  • Calificación de Instalación (IQ)
  • Calificación Operativa (OQ)
  • Calificación de Rendimiento (PQ)
  • Calificación de Diseño
  • Instalaciones y servicios públicos
  • Estrategias para lograr un proceso sólido y confiable.
  • Protocolos típicos de validación de procesos

Quiénes deben asistir:

  • Departamentos de Investigación y Desarrollo
  • Departamentos de Ingeniería
  • Departamentos de Calidad
  • Departamentos de Manufactura
  • Departamentos de Operaciones
  • Departamentos de Producción
  • Profesionales de Control de Documentos
  • Equipos de Desarrollo de Dispositivos
  • Auditores de Calidad
  • Personal involucrado en la planificación, ejecución y documentación de la Verificación y Validación de dispositivos.

Course Director: José Mora

José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.

José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices. José worked for 10 years at Cordis Corporation, now a Cardinal Health company, where he led the successful tooling, process development and qualification of Cordis’ first PTA (percutaneous transluminal angioplasty) catheter.

His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopaedic implants and instruments, and vascular surgery grafts and textiles. During his time at Cordis, José managed the Maintenance and Facilities Department, taking that operation to a level rated as “tops” by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under José’’s leadership.

He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches.