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