Learn a practical and reliable process for monitoring and implementing new requirements in your PQS. Discover how AI can reduce manual review and highlight exactly what impacts your quality system.
A Pharmaceutical Quality System (PQS) is the structured framework that ensures your company consistently complies with GMP and maintains product quality throughout the product lifecycle.
Your PQS defines how you manage processes, documentation, risk, and continuous improvement.
Regulatory requirements change continuously.
If you do not detect and assess them in time, your PQS may no longer be compliant.
This course gives you a practical and reliable approach to PQS compliance.
You will work with a clear process for how to:
• Capture new external regulatory requirements
• Assess their relevance and impact on your quality system
• Decide what needs to change
• Implement updates in a structured way
You will see how others structure their work and where they experience the greatest challenges.
We guide you through a robust process that helps you avoid blind spots and reduce manual guesswork.
You will see how an AI-based tool can support your work by:
• Identify relevant regulatory requirements
• Map them to your quality documents
• Support impact assessment
• Provide overview of deadlines and compliance status
You work with practical examples and discussions throughout the day.
The course language is English.
At the course you will meet:
Anette Yan Marcussen, Senior Pharma Consultant, Marcussen Group ApS
