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