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Listado de Cursos/Adiestramientos

Unidad De Desarrollo Profesional y Adiestramiento

Quality (Training/Course Programs) List

 JOB CENTER PR puede desarrollar o proveer el adiestramiento/curso o programa, no limitado a:

  • Certificación en Validación Industrial I- 4 dias
  • Certificación en Validación Industrial II - 4 dias
  • FDA Computer System Validation Certification
  • CAPA and Investigation Training Certification- 3 dias
  • Certificación en Inspector de Calidad
  • cGMPs Trainer Certification Program
  • cGMP for Pharmaceuticals Industry (CFR 21 Part, 210, 211)
  • Buenas Practicas de Laboratorio- No Clinico (GLP)
  • Quality System Regulation (QSR?s) MEDICAL DEVICES, CFR 21, Part 820
  • ISO 13485 Regulation Course
  • Quality System Regulation (QSR?s) MEDICAL DEVICES, CFR 21, Part 820 for ISO 9000-2000 Certified Organizations
  • Como escribir efectivamente procedimientos Operacionales (SOP?s) para la Industria Regulada: Farmacéuticas, Biotecnología, Dispositivos Médicos, Planta Química, 2 días
  • Revisión de Lotes (Batch Record Review)
  • How to Handle Investigations & Deviations
  • How to document and Handling Regulated documentation
  • Quality Assurance Unit: knowing the roles and responsibilities
  • Quality Subsystems: Ensuring Compliance and Product Quality
  • FDA Inspection System Approach and the Consequences of Non-Compliance
  • Internal Auditing for cGMP Compliance I & II
  • Drug Product Submissions for US Regulated Industries
  • Vendor and Contract Supplier Qualification
  • New Drugs Application Submission and Post Approval Changes
  • Post Approval Changes & Change Control
  • Introduction to Regulatory Affairs
  • Quality Assurance in-Process Roles/Manufacturing/Packaging Process
  • Post Approval Changes and Final Product Disposition Roles and Responsibilities
  • Develop, implement and Maintains an Effective CAPA Program
  • Determine the Root Causes and Corrective Action for Product Quality Issues.
  • Audit your CAPA System for FDA Compliance
  • Analytical Problem Solving Techniques / Root Cause Analysis
  • Technical Writing for Compliant Documentation
  • Risk Assessment and Risk Management for Medical & Drug Industry

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