Presented by: Connie Leech, Global Director Quality, Compliance & Regulatory Affairs , CAI
Top Reasons to watch
- Comprehensive Overview: Get a comprehensive overview of Annex 1 and its role in ensuring the sterility and quality of medicinal products, empowering you with essential knowledge for your role in the industry.
- Expert Insights: Gain valuable insights from industry experts on the intricacies of Annex 1 compliance, contamination control, risk management, and regulatory expectations.
- Stay Ahead of Deadlines: Understand the critical compliance deadlines and exceptions, helping you avoid disruptions in product availability.
- Enhanced Quality: Explore the significance of quality risk management (QRM) and contamination control strategies, ensuring the highest operational standards for your medicinal products.
- Risk Management Expertise: Explore the elevated importance of Quality Risk Management (QRM), a critical component in the pharmaceutical industry, and learn risk-based thinking techniques.
- Real-world Application: Learn practical strategies and techniques that you can immediately apply in your organization, ensuring smoother compliance, risk reduction, and operational excellence.
- Regulatory Insights: Get an inside investigate the regulatory expectations, with a focus on flexibility in implementation, and how to navigate potential challenges.
- Qualified Person Perspective: Understand the viewpoint of a Qualified Person (QP) during the manufacturing process, providing unique insights for product release and audits.
- Patient Safety: Gain a deeper understanding of how Annex 1 compliance directly impacts patient safety, ensuring your products meet the highest standards.
- Continuous Improvement: Discover how to implement continuous improvement strategies within your organization, fostering a culture of quality and risk management.


