Training

Customised Training : Quality System/ GxP/ GMP/GDP/Quality Auditor/Laboratory 

    • GMP / cGMP for Finished Pharmaceuticals and Active Pharmaceutical Ingredients (APIs) – FDA & EU
    • GxP for Managers & Technical Personnel- Advanced level
    • GMP for the Laboratories QC & R&D
    • Internal Auditor Training for GxP/ GMP/ Quality System Compliance
    • QSR/ISO13485 for Medical Devices FDA & EU
    • Clean Rooms and Aseptic Processing –EU Annex 1 & FDA
    • Designing & Delivering Effective GxP /GMP Training  (Train the GMP/GxP Trainer)
    • Good Distribution Practices (GDP)
    • Good Practices for Sales & Marketing
    • GxP and the Role of the Marketing Authorization Holder (MAH)
  • Courses are  customised to company needs and available at Induction, Foundation and Refresher levels, for all levels of responsibility.
  • The competency of participants is assessed.
  • Courses may be presented in-house or at external venues.

Management Coaching/Mentoring

 Senior Managers assuming new roles or embarking on new projects with regulatory implications