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