PQS Compliance with New Requirements

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 remain compliant.This course provides a practical and reliable approach to PQS compliance.You will work with a clear process for:

• Capturing new external regulatory requirements
• Assessing their relevance and impact on your quality system
• Deciding what needs to change
• Implementing 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:

• Identifying relevant regulatory requirements
• Mapping them to your quality documents
• Supporting impact assessment
• Providing an overview of deadlines and compliance status

You will work with practical examples and discussions throughout the day.

Your benefit

• You will gain a clearer structure for monitoring and implementing new regulatory requirements in your PQS.
• You will perform focused and practical impact assessments of new requirements.
• You will understand how structured processes and AI can reduce manual review and improve overall overview.

Your company's benefit

• Your employee will strengthen PQS compliance through a more systematic approach to new regulatory requirements.
• Your employee will achieve faster and more consistent assessment of regulatory impact, supported by AI-based requirements mapping.
• Your employee will reduce the risk of overlooking critical compliance gaps.