To become familiar with concepts of quality assurance in the pharmaceutical industry. The student will become autonomous in finding and reading the guidelines published in the sites of Eudralex and ICH.
Course Prerequisites
The course requires the knowledge that comes from Pharmaceutical Technology teachings
Teaching Methods
Lectures and class activities about the topics covered in the course, aimed at improving the skills related to the reading of the guidelines concerning the Quality aspects (GMP and ICH).
Assessment Methods
Oral evaluation of the ability to find, read and discuss the guidelines about the subjects of the course
Texts
Material provided during the lectures. EMA and ICH guidelines, found in Eudralex and ICH websites.
Contents
Concepts and tools of quality assurance and quality by design will be approached though the GMP and ICH guidelines. In particular, aspects relating to the quality system and the organization of the pharmaceutical industry, including personnel and documentation, will be explored. Attention will be paid to risk assessment and Design of Experiments methods, with reference to applications in the Quality by Design approach.
