TRAINING

IRC has designed and tailored a variety of training programs for manufacturers of medical device, pharmaceutical and biotech companies in the U.S. and internationally. From a broad range of subjects covering general compliance matters, U.S. Law and Regulations, the "how to" on product submissions to detail subjects such as complaint handling and investigations, hundreds of individuals have successfully benefited from IRC's training programs.

Our non classical approach in designing training programs is engaging, interactive and highly effective. The training we have provided has targeted multidiscipline functions within a company as well as regulators from foreign health ministries.

TRAINING AND EDUCATION SERVICES
  • Regulatory Affairs Administration
    • U.S. Federal Food Drug and Cosmetic Act
    • U.S. Code of Federal Regulations
    • U.S. Food and Drug Administration Operations
  • International Requirements -- MDD93/42/EEC -- IVDMD 98/79/EC
  • U.S. Quality Systems Administration (cGMP)
  • ISO/EN Standards
  • Complaint Handling Systems
  • Medical Device Reporting / Adverse Event Reporting
  • Document Control / Design Control Practices
  • Submissions
    • Premarket Notification 510(k) System
    • Investigational Device Exemption and Clinical Trails
    • Premarket Approval Applications
  • Staff Development and Education
  • Senior and Executive Management
  • General and Departmental Management
  • Production and Quality Control Operations