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