servizi-formazione-e-sviluppo

Training & Development

From the hominid to the scientist, evolution has progressed due to the acquisition of knowledge.

Training is a knowledge transfer that creates competence.

Training is an investment for the present indispensable for the evolution of, and innovation in the company.

Training is not only an obligation imposed by rules or by certifications! Even where there is not a requirement, trained staff is proactive, intent on improving daily operations, able to detect anomalies or inefficiencies and, consequently, to take corrective action.

Dueali consulting transfers knowledge and skills through

  • Courses in the classroom at their premises and / or at the Client
  • Organization of events related to recent regulations, on fundamental topics
  • “Training on the Job” during project deployment

to reach important goals

  • Transmit new market trends
  • Update and explore sensitive issues

in a pragmatic way

  • Training courses and events with a limited number of participants
  • Communication of concepts, tools, questions and discussion points
  • Practical Case studies dealt with in groups.

Areas: 

Process Optimization

  • Techniques and Tools for process mapping
  • LEAN/LAB/QA: ChimeraorOpportunity? Principlesandtoolsto maximize efficiencyin the laboratory
  • How tosuccessfully implementaLIMS systemfor managinglaboratory data “without paper” (paperless)
  • Electronic document management(EDMS) and processquality(QMS)
  • Electronic managementandsubmissionof theRegistration Dossierof thedrug (eCTD)

 Quality Systems

  • ISO 9001:2008
  • ISO 9001:2015
  • Quality System for Pharmacovigilance
  • Quality Assurance SOPs for GMP, GLP and GCP contexts
  • ISO 22716 and GMP in Cosmetics

 Project Management

  • Techniques and Tools for project management and control
  • EffectiveMeetings(skills and tools tocommunicate effectively)
  • Time and stress management
  • Definition, management and control of an information system implementation project. 

Computer System Validation

  • Electronic Record and Electronic Signature according to FDA CFR21part11 and EU Annex11
  • Computerized System Validation
  • Validation of Excel Spreadsheet with calculations
  • Automation of activities for Validation of Excel Spreadsheet with calculations according to current rules (GxP, FDA CFR21part11, ISO 17025)
  • Validation of Business Intelligence systems used to navigate data of centralized systems (ERP, LIMS, EDMS, SDMS,…).