In the pharmaceutical industry, identifying and addressing Out of Specification (OOS) results is not just a regulatory requirement, it’s a crucial quality practice. Ensuring thorough OOS investigations and robust quality systems within laboratories is essential yet often challenging. Effective OOS investigations are vital for maintaining regulatory compliance and enhancing product quality. The role of quality assurance professionals in this context demands a diverse skill set—from understanding the fundamentals of OOS investigations to applying intricate technical knowledge across various analytical methods.
This workshop addresses these diverse needs by providing insights into the regulatory framework and best practices for conducting OOS investigations. Designed for laboratory analysts, quality assurance professionals, and regulatory affairs specialists, this course equips participants with the necessary skills to navigate the complexities of OOS investigations, covering aspects such as root cause analysis, documentation, and corrective and preventative actions. Join us for a structured approach to OOS investigation readiness, ensuring your laboratory is consistently prepared and confident in its compliance efforts. Let’s embark on a journey towards controlled, stress-free OOS management, ensuring your laboratory maintains the highest quality standards.
This workshop is ideal for individuals involved in the investigation, documentation, or management of Out of Specification (OOS) results in a GMP-regulated laboratory setting. It is particularly beneficial for quality assurance professionals, regulatory affairs specialists, laboratory analysts, and supervisors responsible for ensuring compliance, product quality, and continuous improvement within their organizations.
This workshop covers the following topics:
Develop the ability to identify and differentiate OOT and OOS results, applying regulatory guidelines to assess compliance risks.
Conducting Effective OOS InvestigationsLearn how to systematically perform Phase 1 OOS investigations, including hypothesis testing, remeasurement, retesting, and resampling.
Documenting and Reporting OOS FindingsUnderstand best practices for maintaining quality documentation, concluding investigations, and effectively reporting test results.
Preventing Future OOS OccurrencesExplore strategies to minimize OOS results through proactive quality control measures and process improvements.
All participants will receive a certificate of attendance upon completion of the workshop.
