Forced Degradation and Impurity Monitoring
Philadelphia, United States
Stability is a critical quality attribute in the development of pharmaceutical product. Stability data establishes quality of the product and support the proposed specifications. Pharmaceutical quality system (PQS) must be built to maintain integrity and quality throughout the product lifecycle. Stress testing and stability-indicating methods are also necessary in the product development and monitoring of stability studies. Different regulations and initiatives of monitoring organic impurities; and evaluation of stability data and data trending based on Quality-by-Design (QbD) and Quality Risk Management (QRM) to establish critical quality attributes are addressed. This live and interactive course delivers advanced technical issues to design the most effective stability program; and covers forced degradation studies to establish stability-indicating methods, monitoring organic impurities, handling deviations, data investigations, and different control strategies to improve stability program and manage regulatory inspections. It is designed for directors, managers, supervisors, project managers, analysts, quality assurance professionals or quality control personnel working with pharmaceutical products.
Participants must take the fundamental course or have at least 3-year experience with the stability program to participate in this course.
***Attend this event along with Stability Testing & Program Management Roadmap and save $200.00! Use promo code 2DAYSAVE to register for both seminars and save!***