Regemon LLC
 
 
  Regulatory Affairs and Quality Systems Consulting
 
             
   
 
Training: Regulatory/ Quality/ Compliance

Regemon provides customized in-house training for individuals, small or large groups, organizations’ management or production personnel working in FDA- or ISO-regulated environment. 

FDA Regulations

  • 21 CFR 820 Quality System Regulations
  • Quality System Regulations for Management
  • Quality System Inspection Techniques (QSIT)
  • FDA Inspection Preparation
  • CAPA process and effective Root Cause Analysis
  • Complaint Handling and 21 CFR 803 Medical Device Reporting
  • 21 CFR 806 Corrections and Removals (Recalls)
  • Preparation for FDA and foreign inspections

International Regulations/ Standards

  • CE Marking: Regulation (EU) 2017/745 [MDR] replacing EU Directives for Medical Devices (MDD/ AIMD/ IVDD)
  • Canadian Medical Device Regulations
  • Japanese PAL
  • EU Vigilance Process
  • Internal auditing for FDA QSR and ISO 13485
  • ISO 13485: 2016 Quality Management System
  • ISO 14971: 2012 Risk Management
  • Preparation for FDA and Foreign Regulatory Bodies Inspections 

Training Services- In-house courses or offered at Northeastern University:

  • European Union Compliance Process and Regulatory Affairs1
  • Global Awareness: European Medical Device Regulations 1

1) The instructor is a former faculty member at Northeastern University in Boston, MA where he taught graduate-level courses offered under the Masters Degree in Regulatory Affairs program.

     
   
 
Welcome Regulatory Compliance Quality Systems Training EU (CE) Compliance Resources Contact Us
 
 

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