Regulated Bioanalysis – Trends, Challenges and Practices

Advanced Bioanalytical Science is designed for participants to have an adequate understanding of recent Trends, Challenges and Industry Standards/Practices applied to Bioanalytical Lab intended to carry out Regulated Bioanalysis in support of ANDA/IND submissions. Some hands on exercises are also designed to train personnel on practical aspects of Latest Quality Practices and Industry Standards applicable to Regulated Bioanalysis

Enhance knowledge about science, quality and regulatory standards keeping ethics as focal point. Update them about the current scientific practices, GxP and international regulatory requirements for conduct the Bioanalysis to support Healthy and
Patient BA/BE studies. This training will include both true expertise and hands on elements to achieve best
understanding of current industry trends, exiting challenges and international regulatory requirements for bioanalysis, and qualified interpretation of these requirements during inspections.