Presented by: Connie Leech, Global Director Quality, Compliance & Regulatory Affairs , CAI

Top Reasons to watch

  1. 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.
  2. Expert Insights: Gain valuable insights from industry experts on the intricacies of Annex 1 compliance, contamination control, risk management, and regulatory expectations.
  3. Stay Ahead of Deadlines: Understand the critical compliance deadlines and exceptions, helping you avoid disruptions in product availability.
  4. Enhanced Quality: Explore the significance of quality risk management (QRM) and contamination control strategies, ensuring the highest operational standards for your medicinal products.
  5. 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.
  6. Real-world Application: Learn practical strategies and techniques that you can immediately apply in your organization, ensuring smoother compliance, risk reduction, and operational excellence.
  7. Regulatory Insights: Get an inside investigate the regulatory expectations, with a focus on flexibility in implementation, and how to navigate potential challenges.
  8. Qualified Person Perspective: Understand the viewpoint of a Qualified Person (QP) during the manufacturing process, providing unique insights for product release and audits.
  9. Patient Safety: Gain a deeper understanding of how Annex 1 compliance directly impacts patient safety, ensuring your products meet the highest standards.
  10. Continuous Improvement: Discover how to implement continuous improvement strategies within your organization, fostering a culture of quality and risk management.

SPEAKERS

Connie Leech

Global Director of Quality, Compliance and Regulatory Affairs, CAI


Connie Leech is Global Director of Quality, Compliance and Regulatory Affairs in the Life Science Industry with CAI. She has significant practical experience in Biopharmaceuticals (including Sterile Fill Finish) Pharmaceutical, Drug Substance and Oral Solid Dose. She has 30 years of international hands-on experience in quality management, regulatory compliance, validation, strategic and operations management in manufacturing and quality control.

Connie has a BSc., Hons. in Microbiology and a Post Graduate Diploma in Pharmaceutical Manufacturing Technology (Qualified Person) from Trinity College, Dublin.  She is also an experienced Qualified Auditor, assisting in audit preparation, management, and hosting of Global Regulatory authorities and supporting suppliers and contractors to drive measurable improvements to their Quality Management System.

Connie leads and coaches’ teams through periods of transformation to achieve excellence in the effective implementation and management of quality systems and optimization of business performance.

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