General Methods for Sterilization Processes Applied to Pharmaceuticals Epidemiology Seminars

Two aspects justify this discipline. The first one concerns the great demand existing in the HC / FMUSP complex on the debate and understanding of projects / studies that use epidemiological methodology, and articles published in scientific journals. The second aspect concerns the possibility of integrating the different fields and disciplinary areas of research of the complex, facilitating the incorporation and understanding of the methodological instruments by the graduate students and discussing the validity of the use of these instruments in specific researches. Discuss current epidemiological and related issues Analysing the validity of studies using epidemiological methodology Understand subjects relevant to the postgraduate in the health area Medical School (FM) São Paulo, Pinheiros campus The course will be given in the form of seminars. Papers will be analyzed from epidemiological studies or on topics important for research in the health area, published or to be submitted for publication in national and foreign scientific journals, and projects / studies that use epidemiological methodology. Eventually, faculty and researchers from the institution or from other institutions may present a topic related to their area of research. Jose Eluf Neto 25 MPR5749 4 Presentation and participation in seminars

General Methods for Sterilization Processes Applied to Pharmaceuticals

Sterilization processes are performed in laboratories, hospitals and industries as the final processing step for preparation of safe critical materials and devices used in the Public Health sector and for pharmaceutical products, in order to preserve products and to ensure their expected shelf-life. A better understanding of sterilization processes (as the choice of sterilizing agent to be used, kinetic parameters determination and biological indicators application) can minimize misunderstandings related to contamination, production and/or processing of these pharmaceuticals devices. This course aims to present the basic concepts and parameters related to sterilization and validation processes, which are responsible to guarantee consistent sterility levels required for obtaining pharmaceutical and medical products. School of Pharmaceutical Sciences (FCF) São Paulo main campus 1. Introduction_- Concepts and application of sterilization. 2. Kinetic parameters: Decimal reduction time (D-value), Relative resistance (z-value), Sterility Assurance Level, Process equivalent time (F value), Q10 parameter and activation energy. 3. Biological and chemical Indicators: main characteristics, types, applications and relationship. 4. Sterilizing agents: Physical, chemical and gaseous agents. 5. Validation processes: definitions and legislation, qualification of installation, operating system qualification_and physical and biological validation. Practical: Application of biological indicators, determination of kinetic parameters Marina Ishii 13 FBT5736 6 Exercises and seminars.