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Adiestramientos y Formación

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Listado Completo de 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) >>brochure<<

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)