CONSULTING, AUDIT AND TRAINING -
PHARMACEUTICAL AND COSMETIC INDUSTRIES
Specialist in the pharmaceutical and cosmetic industries, we support you in your transformation and optimization projects
Consulting & Audit
We are a specialized consulting and training firm for the drug industries.
Our expertise:
- Quality System Audit & Optimization (GMP and ICH Q10)
- Internal audit, inventory and performance diagnosis
- Support in Data integrity compliance
- Support in the risk analysis process (ICH Q9)
- External audit: suppliers and subcontractors
- Technical and organisational project support and expertise
- Support for the formulation of pharmaceutical products - Technical expertise
GMP training
Pharmaceutical Quality System (ICH Q10)
How to successfully implement a pharmaceutical quality system (ICH Q10)?
Objectives:
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
good manufacturing practices
How to implement Good Manufacturing Practices in a GMP environment? How to ensure compliance of pharmaceutical operations in a GMP environment?
Objectives:
Identify the risks applicable to your department’s activities
Apply GMP rules within your entity
Understand everyone’s responsibilities in implementing GMP requirements
Data Integrity in the Pharmaceutical Industry
How to ensure data integrity in a GMP environment? What requirements should be implemented?
Objectives:
Understand data integrity requirements
Understand and apply data integrity criteria (ALCOA principle)
Federate its teams around “Data Integrity”
Change management - Change control
How to implement an effective change management approach in a GMP environment?
Objectives:
Understand change management expectations
Implement an effective management system
Define the governance associated with this approach
Management of deviations
How to treat deviations effectively? Method and tools for an efficient and optimal quality approach
Objectives:
understand regulatory requirements
Optimize the deviation process
Use tools appropriately
CAPA Management
How to implement an efficient CAPA management system? Which strategy to implement?
Objectives:
Understand regulatory requirements
Define an optimal system for CAPA management
Focus Areas
the opinions of our customers
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.
Delphine
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.
Auditeur AQ
Pragmatic, operational and synthetic approach.
Resp. Qualité