Navigating Out-of-Specification (OOS) Results in Stability Studies
Webinar Date & Time
Thursday, 22nd of May, 2025
2:00 pm (Ireland) | 3:00 pm (Belgium) | 09:00 am (Durham, NC, USA)
Register now
Join Q1 Scientific and Philippe Bollen, Co-Founder and Managing Director of QP Pro Services in Belgium, as we explore the issue of Out-of-Specification (OOS) results encountered during stability studies — a critical concern in pharmaceutical development and quality assurance.
Stability studies, conducted under stringent ICH guidelines (e.g., Q1A(R2)), are essential for evaluating the chemical, physical, microbiological, and functional integrity of drug products throughout their shelf life under defined storage conditions.
The emergence of OOS results can signal product degradation, formulation instability, or variability in analytical performance. These findings necessitate comprehensive investigations in accordance with FDA and EMA guidance to differentiate between true quality defects and aberrant analytical or procedural anomalies. Addressing OOS outcomes effectively is crucial to maintaining regulatory compliance, ensuring timely market authorization, and safeguarding patient safety.
Register now to gain valuable insights into managing OOS results and mastering the best practices for overcoming these challenges in pharmaceutical quality assurance.
Speaker profile
Mr. Philippe Bollen
Co-Founder and Managing Director, QP Pro Services SRL
Philippe Bollen is an industrial pharmacist with extensive experience in pharmaceutical operations and quality systems. As the Co-Founder and Managing Director of QP Pro Services, he brings a wealth of expertise in GMP, GDP, and ISO 13485 standards. Philippe holds a Master’s degree in Industrial Pharmacy and a specialization in Pharmaceutical Engineering from Université Catholique de Louvain.
With a career spanning over two decades, Philippe has excelled in various roles, including Qualified Person (EU), freelance consultant, and GxP specialist. His areas of expertise encompass quality management, regulatory affairs, pharmacovigilance, and the oversight of contract manufacturing organizations. Philippe is adept at managing quality systems for both non-sterile and sterile products, blood derivatives, monoclonal antibodies (mAb), and advanced therapy medicinal products (ATMP).
Philippe’s professional journey includes significant contributions to renowned organizations such as AstraZeneca, Janssen Pharmaceutical, and Zoetis. He has successfully led quality assurance teams, conducted audits, and ensured compliance with regulatory standards. His commitment to continuous improvement and quality culture is evident through his work as a trainer and project leader at the QP Academy.
Join us to hear from Philippe Bollen, a leader in pharmaceutical quality assurance, as he shares his insights and best practices for navigating Out-of-Specification (OOS) results in stability studies.