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 course is valuable for Directors, Managers, Supervisors, Laboratory Analysts and Associates working in a GMP environment in the Pharmaceutical and related industries with daily responsibilities in the following areas:
This workshop covers the following topics:
Gain a thorough understanding of FDA guidelines and international regulations for conducting OOS investigations and how to apply these in a laboratory setting.
Conducting Effective OOS InvestigationsLearn how to accurately conduct Phase 1 OOS investigations, including identifying the root cause and documenting findings.
Quality Documentation and ReportingDevelop the skills to create, review, and approve quality documentation required to support OOS investigations, ensuring all regulatory requirements are met.
Corrective and Preventative ActionsUnderstand how to implement effective corrective and preventative actions based on OOS investigation findings to minimize future occurrences.
All participants will receive a certificate of attendance upon completion of the workshop.
Note: Registration closes one week prior to the start of workshop.
AAPS
Instructor
A Chartered Chemist, her career spans 30 years in the pharmaceutical industry. She started as a stability chemist at Sterling Drug and soon moved to Health Canada where she worked over 13 years in various capacities with the Health Product Branch Inspectorate (HPBI) in the Ontario region. Her expertise include Medical Devices Inspection, Drug GMP Inspection and Compliance issues. She is currently the director of QA/QC at Experchem Laboratories Inc. where she is responsible for overseeing and maintaining the GMP compliance of the chemistry and microbiology laboratory, Auditing, and providing Quality Control Services to importers and distributors.
She has a degree in chemistry from York University and a diploma in Pharmaceutical Chemical Technology from Seneca College.
