ADVICES AND COACHING
Advice & quality action plan
- CGMP – FDA upgrade of production sites
- Reorganization of the Quality structure in accordance with cGMP
- ICHQ10 compliance of a Quality Management System
- Quality Risk Management (ICHQ9), deviations, CAPA
- Pre, post and inspection assistance
- State of play, Product Quality Reviews, Institution Change Requests
- Supplier’s specifications
- Optimization of document systems, organization of archiving
- Writing of procedures, operating modes, quality manuals
- Design and implementation of internal trainer empowerment processes
Coaching & training
- Coaching Personal Quality Coaching (QP, QP substitute , Operational or Functional Quality Assurance)
- Other quality personal coaching (manufacturing, packaging, control laboratory, maintenance, supply chain, …)
- Design and animation of GMP training modules on-demand (face-to-face, webinars, e-learning, …)
- Assessment of achievements
- Design of educational games, playful approach of GMP
We support you throughout all steps of the conception and lifecycle of your products ensuring a complete quality service.
Thanks to our participation to international networks Regulanet and Pharmaxi, we have a privileged access to specialists in more than 90 countries.
STRATÉGIE SANTÉ
53, Boulevard de la Reine
78000 Versailles - France
Tél : +33 (0)1 42 86 86 00
Our certifications
Member of
Newsletter inscription
Follow us