| Greetings!
In the pharmaceutical industry, identifying and resolving Out of Specification (OOS) results is not only a critical regulatory requirement- it’s a core component of quality assurance. AAPS Pharma invites you to attend an in-depth workshop focused on developing the essential skills and regulatory awareness required to conduct effective OOS investigations in GMP-regulated laboratory environments. Whether you work in QA, regulatory affairs, or the lab, this session is designed to elevate your practical understanding and confidence in handling OOS cases.
The workshop will guide participants through the regulatory landscape, industry expectations, and real-world best practices, with a focus on root cause analysis, documentation standards, and structured corrective and preventive actions. It will also offer valuable insights into Out-of-Trend results, additional testing approaches, and reporting obligations- all through practical case-based learning.
The session will be led by Kevin Mueller, an accomplished pharmaceutical industry professional with over 25 years of experience at Novopharm Ltd. and Teva Canada Ltd. Kevin has held leadership roles in Analytical R&D, QC Stability, Method Transfer, and Operational Excellence. With his hands-on knowledge of laboratory compliance, data integrity, and CAPA implementation, Kevin brings a grounded, solutions-oriented perspective to quality systems training. He holds an M.Sc. in Chemistry from the University of Western Ontario and is recognized for his collaborative teaching style and dedication to continuous improvement.
We look forward to welcoming you to this important session, designed to help you streamline OOS management and ensure your lab is always inspection-ready. | 
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