Adiestramientos y Formación
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Talleres Que Ofrecemos >>descargar brochure<<
Las ventajas de ofrecer un taller internamente son múltiples: más baratos, confidencialidad, adaptación del contenido a sus necesidades especificas y la utilización de casos reales de la compañía para los ejercicios. Nuestros talleres se presentan con un enfoque práctico y la mayoría son de un día. Contáctenos y permítanos ofrecerle una cotización libre de compromiso.
CAPA System
· Effective Problem Solving: Root Cause Analysis and CAPA (2 day)
· Effective CAPA System for the FDA-Regulated Industry: the Ten Biggest Opportunities and How to Fix Them (1 day)
· Human Error Identification, Analysis and Prevention (1 day)
· How to Measure Training System Effectiveness (1 day)
· Train the Trainer for FDA-Regulated Industry (3 day)
· CAPA EXPERT CERTIFICATION (6 days)
GMP – Regulatory & Compliance
· Drug and Biotech GMP Education for Managers and Supervisors (1 day)
· Medical Device QSR Education for Managers and Supervisors (1 day)
· Quality System Compliance for the Pharmaceutical Industry: ICH Q10 & GMP 21 CFR 210 & 211 (2 day)
· ASQ New Certified Pharmaceutical GMP Professional (CPGP) (3 day)
· Quality System Regulations (21 CFR 820) . AAMI-style workshop including exam (2 day)
· Comparative Analysis and Interpretation of Medical Devices QSR (21 CFR 820) and ISO 13485:2003 (1 day)
· Overview of Combination Product Guidance Regulations 21 CFR 4 (1 day)
· ASQ Medical Devices Certification (Certified Biomedical Auditor) (3 day)
· Internal Audit for Drug and Biotech (4 day)
· Internal Audit for Medical Devices: ISO 13485:2003 blended with FDA’s QSR (4 day)
· Supplier Certification: Establishing an Effective Program (1 day)
· ANVISA Brazilian Regulation Analysis and Interpretation (1 day)
· Inspection and Audit Readiness (1 day)
· Foreign Inspection Readiness (Canada, Japan, Europe) (1 day)
Laboratory Quality
· Stability Program for Pharmaceutical Industries (2 day)
· ISO 17025 Accreditation Overview (1 day)
· Analytical Test Methods Validation (1 day)
· Investigating OOS in the Pharmaceutical Q C laboratory (1 day)
· Good Laboratory Practices for HPLC (1 day)
Risk Management
· Medical Devices Risk Management: Analysis and Interpretation of ISO 14971:2007 (1 day)
· Drugs and Biotech Quality Risk Management: A Complete Analysis of ICH Q9 (1 day)
Statistical Knowledge
· Applied Statistics for Non-Statistics using SigmaXL software (3 day)
· Applied Statistics using MINITAB (3 day)
· Design of Experiments (DOE) using MINITAB (2 day)
· SPC (Control Charts and Run Charts) applied to Process Trending and Analysis: Principles and Application to the FDA Regulated Industries (2 day)
· Sampling Best Practices workshop applied to FDA regulated industries. How to use Z1.4 and Z1.9 (1 day)
Technical
· Lean Six Sigma Green Belt ASQ Certification (6 day, $1,695)
· Lean Six Sigma Green Belt for Healthcare (6 day, $1,695)
· Lean Six Sigma Black Belt ASQ Certification (12 day)
· Value Stream Map (1 day)
· 5-S (1 day)
· Kanban (1 day)
· Practical FMEA (Failure Mode and Effect Analysis) Workshop (1 day)
· Geometrical Dimensioning & Tolerancing (GD&T) (1 day)
Compliance and Technical Writing
· How to Design and Write Effective Procedures, Working Instructions and Forms for the FDA-Regulated Industry (2 day)
· Writing Effective Investigation Reports and CAPAs for the Regulated Industry (2 day)