October 22, 2018 @ 9:30 AM - 4:30 PM
Philadelphia, United States
Stability studies are an essential component of pharmaceutical development and manufacturing used to establish a retest date for active pharmaceutical ingredient (API) or a shelf-life for drug products (DP). The stability program studies the behaviors of API and DP under the influence of a variety of environmental factors such as temperature, humidity, and light. ICH has placed a foundation for stability program and continues to be the driving force of new quality initiatives. A comprehensive review of ICH Q1 family (Q1A to Q1F) will be done to build the program infrastructure. The product shelf-life is established based on stability data during development phases and continue to support the change control program in commercial phase. This live and interactive course delivers a comprehensive look at ICH and global regulations and operational issues surrounding the stability program. It is designed for directors, managers, project managers, quality assurance professionals or quality control personnel seeking to understand and develop an effective stability program for their pharmaceutical products.
***Attend this event along with Advanced Stability Testing & Program Management and save $200.00! Select the dual event ticket type for $1790.00 to register for both seminars and save!***