The major objective of this course is to provide a detailed insight into the practical aspects and approaches of process scale-up for different unit operations and technologies.
Interview with Asya Chernyavskaya
Read the short interview with Asya Chernyavskaya, Executive Director in Microbiological Center, Akrikhin, Russia.
What were the areas where you have faced risks and had to mitigate them? What were the steps you had to undergo?
It's important to manage risks in all areas and stages related to the quality of a drug: R&D, assessment of a design for a warehouse/quality control laboratory, assessment of necessity for implementing changes, investigation of deviations, evaluation of suppliers, etc.The process of risk management includes the task of taking accurate (maybe at times risky, but conscious and well-balanced) decisions. The outcome of the risk management process: confidence in stable and predictable manufacturing processes.
Interested in this topic?
Targeted Drug Delivery
Gain detailed overview of the newest strategies in drug delivery and targeting.
Next Generation Antibody Therapeutics
This focused 2-day training will cover the discovery, engineering and production of next-generation antibodies, antibody fragments, bispecific Abs, innovative ADCs and more. Follow the path from their discovery and selection through engineering and expression to production and regulatory issues.
White Paper: Beyond the Cold Chain
Take a Good Look at the Future of Corporate Universities
There are four things corporate universities can do to avoid becoming irrelevant in the digital age.
Ready for the new GCP ICH E6 (R2) addendum?
On the 23rd of July 2015, the EMA's Committee for Human Medicinal Products released the Guideline for Good Clinical Practice E6(R2) for consultation. On the 14th of June 2017, it will come into effect and influence everyone involved in the clinical research process. What does it mean to pharma and biotech companies, sponsors, CROs, research institutes and third-party organizations?