Specialist in the pharmaceutical and cosmetic industries, we support you in your transformation and optimization projects
We are a specialized consulting and training firm for the drug industries.
How to successfully implement a pharmaceutical quality system (ICH Q10)?
Understand Regulatory Requirements (GMP – ICH Q10)
Establish a strategy for implementing a pharmaceutical quality approach within your institution
Identify the action levers for an effective and sustainable implementation
How to implement Good Manufacturing Practices in a GMP environment? How to ensure compliance of pharmaceutical operations in a GMP environment?
Identify the risks applicable to your department’s activities
Apply GMP rules within your entity
Understand everyone’s responsibilities in implementing GMP requirements
How to ensure data integrity in a GMP environment? What requirements should be implemented?
Understand data integrity requirements
Understand and apply data integrity criteria (ALCOA principle)
Federate its teams around “Data Integrity”
How to implement an effective change management approach in a GMP environment?
Understand change management expectations
Implement an effective management system
Define the governance associated with this approach
How to treat deviations effectively? Method and tools for an efficient and optimal quality approach
understand regulatory requirements
Optimize the deviation process
Use tools appropriately
How to implement an efficient CAPA management system? Which strategy to implement?
Understand regulatory requirements
Define an optimal system for CAPA management
Thank you for your support. I feel much better and can therefore approach the future more serenely. I realize that this coaching has been very beneficial to me both professionally and personally.
Complete and customized training. Interactive and dynamic presentations adapted to our organization and our problems. Enriched by the experiences of the trainer and captivating anecdotes, they allow the topics discussed to become concrete and transposable.
Pragmatic, operational and synthetic approach.