Journal of Pharmacovigilance

Increase and effectiveness in the activity of audits of quality in the Center of Genetic Engineering and Biotechnology

6^th Pharmacovigilance Congress

September 28-30, 2016 Toronto, Canada

Mariela Diaz Cinza

Havana University, Cuba

Posters & Accepted Abstracts: J Pharmacovigil

Abstract:

This poster presentation aims at sharing the experiences of a study carried out by a group of researchers who audited the quality at the Center of Genetic Engineering and Biotechnology in Havana, Cuba, by means of its correct planning and control. For this purpose, bibliographical review as well as methods such as interviews, brainstorming, group decision-making and causes-effect diagrams was necessary. The application of the methods made it possible to carry out the diagnosis and analysis of the situation and to give a solution to the problem. The diagnosis showed that the activity does not guarantee a continuous improvement of the processes and quality of the system. Some actions were implemented, such as: Upgrading the procedures and forms of the activity, creating an organizational structure and making audit programs to accomplish different activities and processes. These actions rendered remarkable results for audits, since they included the evaluation by suppliers, the internal audits and the protocols, final reports and critical phases of the preclinical and clinical tests.

Biography :

Email: raydelhernandez1982@yahoo.com